[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-negative-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-negative-breast-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,44,65,77,87,115,141,183,213,237,262,290,313,332,354,379,442,466,489,514,535],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053526","phase-3-testing-whether-hormone-therapy-with-ribociclib-is-as-effective-as-chemotherapy-followed-by-hormone-therapy-with-ribociclib-for-the-treatment-of-high-anatomic-stage-breast-cancer-with-low-recurrence-risk-the-rxfine-low-trial-100053526",false,"NCT07391774","Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial","A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos\u002FHER2-neg Breast Cancer With RS≤25 (RxFINE-Low)","Inclusion Criteria:\n\n* STEP 0: Patient must be ≥ 18 years of age\n* STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration\n* STEP 0: Patient must be a postmenopausal woman or a man\n\n  * NOTE: Menopause can be determined by any of the following:\n\n    * Prior bilateral oophorectomy\n    * Age ≥ 60 years\n    * Age \\\u003C 60 years with amenorrhea for ≥ 12 months and estradiol and follicle stimulating hormone (FSH) levels in the postmenopausal range\n  * NOTE: FSH and estradiol levels should be repeated as clinically indicated to ensure menopausal status in patients with breast cancer with chemotherapy-induced amenorrhea\n* STEP 0: Patient must meet one of the following staging criteria postoperatively according to American Joint Committee on Cancer (AJCC) 8th edition criteria\n\n  * pT0-T3 with 3 positive ipsilateral lymph nodes (micro-or macrometastatic disease) and no planned axillary lymph node dissection after definitive surgery in the breast and axilla with curative intent.\n  * pT0-T3 with N2 or N3\n  * pT3 with N0-N3\n\n    * NOTES:\n\n      * Patients with T4 breast cancer are not eligible.\n      * Positive isolated tumor cells (ITCs) in axillary nodes without micro- or macrometastasis are considered N0 for eligibility purposes.\n      * ITC does not contribute to nodal count for staging purposes\n* STEP 0: Patient must have a primary breast tumor that is estrogen receptor (ER) positive with \\> 10% ER expression by immunohistochemistry (IHC) as per 2020 American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) Estrogen Receptor Testing Guideline.\n\n  * NOTE: ER 1-10% are reported as ER low positive. These tumors have less endocrine-sensitive disease and are not eligible)\n* STEP 0: Patient must have a primary breast tumor that is HER2-negative by current ASCO\u002FCAP guidelines utilizing immunohistochemistry and\u002For fluorescence in situ hybridization (FISH)\n* STEP 0: Patient may have multicentric or multifocal breast cancer if the highest stage tumor meets eligibility criteria outlined above, and the tumor sites are felt to represent a single disease process by local pathology or other sites of disease are also ER-positive (\\> 10%) and HER2 negative, if such testing is completed. If local pathology feels that multicentric or multifocal disease may represent distinct disease processes repeat disease receptor testing is required other sites of disease must also be also ER-positive (\\> 10%) and HER2-negative\n* STEP 0: For patients who have undergone a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection\n* STEP 0: For patients who have undergone mastectomy, the margins must be free of residual gross tumor. Patients with microscopic positive margins are eligible if post-mastectomy radiation treatment (RT) of the chest wall will be administered\n* STEP 0: Patient must have undergone axillary staging with sentinel lymph node biopsy (SLNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND)\n* STEP 0: Patient must have no evidence of locoregional or distant metastatic disease by clinical history and physical exam. Treating physician can consider additional imaging evaluation per National Comprehensive Cancer Network (NCCN) guidelines and\u002For institutional practice\n* STEP 0: Patient must be able to have Oncotype DX testing performed.\n\n  * If Oncotype DX testing was previously performed, the results of Recurrence Score (RS) must be available and must meet Step 1 eligibility criteria.\n  * If Oncotype DX testing was not performed yet, tissue from the core, excisional biopsy or surgical specimen of the tumor lesion must be available and must be shipped to Exact Sciences for determination of the Oncotype DX Recurrence Score (RS) for eligibility and stratification.\n\n    * NOTE: Exact Sciences will notify the submitting institution of Recurrence Score results within two (2) weeks of receipt of the tumor specimen. Institutions will receive an email notification of eligibility status once Recurrence Score results are entered into Rave by the submitting institution\n* STEP 0: Patient must have had their final cancer surgery for breast cancer (including re-excision of margins) less than 16 weeks prior to Step 0 Pre-Registration.\n\n  * NOTE: This excludes additional surgery for reconstructive purposes\n* STEP 0: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 0: Patients with synchronous DCIS or LCIS are eligible\n* STEP 0: Patient with prior history of ER-negative DCIS diagnosed at least 5 years prior to Step 0 Pre-Registration without evidence of recurrence are eligible\n* STEP 0: Patient must not have a prior history of invasive ER-positive breast cancer. Patients with a history of ER-negative breast cancer are eligible if they were diagnosed at least 5 years prior to Step 0 Pre-Registration and have had no evidence of recurrence\n* STEP 0: Patients must not have received prior endocrine therapy such as tamoxifen, raloxifene, or aromatase inhibitors for chemoprevention within 5 years prior to Step 0 Pre-Registration with the exception of a short course of endocrine therapy of less than 6 weeks duration prior to Step 0 Pre-Registration.\n\n  * NOTE: The Oncotype Dx for study eligibility must be performed on specimen obtained prior to initiation of any endocrine therapy\n* STEP 0: Patient must not be concurrently using systemic hormone replacement therapy (HRT). If receiving HRT at the time of breast cancer diagnosis, this must be discontinued prior to Step 0 Pre-Registration with appropriate washout\n* STEP 0: Absolute neutrophil count (ANC) ≥ 1,500\u002FµL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Platelets ≥ 100,000\u002FµL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Total bilirubin ≤ institutional upper limit of normal (ULN) or \\\u003C 1.5 x ULN for patients who have a bilirubin elevation in patients with well documented Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × institutional ULN (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fminute\u002F1.73 m\\^2 (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 Pre-Registration are eligible for this trial\n* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 0: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better\n* STEP 0: Patient must have a standard 12-lead electrocardiogram (ECG) within 28 days prior to Step 0 Pre-Registration, documenting:\n\n  * QT interval using Fridericia's correction (QTcF) \\\u003C 450 msec.\n  * Resting heart rate 50-90 beats per minute (determined from the ECG)\n* STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* STEP 0: Patient must not have comorbidities considered a safety risk for standard adjuvant chemotherapy, endocrine therapy or CDK4\u002F6 inhibitor as per Investigator's discretion\n* STEP 0: Patient must not have a contraindication to adjuvant chemotherapy based on treating physician's discretion\n* STEP 0: Patient must not have received prior chemotherapy for this malignancy\n* STEP 0: Patient must not have received prior CDK4\u002F6 inhibitor\n* STEP 0: Patient must not have a known contraindication to ribociclib per current Food and Drug Administration (FDA) indication\n* STEP 0: Patient must not have a known hypersensitivity to any of the excipients of ribociclib and\u002For endocrine therapy (ET) (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy)\n* STEP 0: Males must not expect to father children and males and their partners must be willing to use highly effective methods of contraception while on protocol treatment. Males must not donate sperm while on protocol treatment and for at least 12 weeks following the last dose of protocol treatment.\n\nHighly effective methods include the following:\n\n* Intrauterine device\n* Bilateral tubal occlusion\n* Vasectomized partner\n* Sexual abstinence If the highly effective contraceptive methods are contraindicated or strictly declined by the patient, or in the event of sexual activity of low frequency, a combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods) is also considered an acceptable birth control method. Local regulation\u002Fguidelines are to be followed with regard to highly effective birth control method, if more restrictive\n\n  * STEP 1: Patient must meet all Step 0 Pre-Registration eligibility criteria at the time of their Step 1 randomization\n  * STEP 1: Patient must not have had any major surgery or radiotherapy within 14 days prior to Step 1 randomization\n  * STEP 1: Patient must have a Recurrence Score (RS) of 0-25 from Oncotype DX testing from diagnostic biopsy or surgical specimen as reported by the Exact Sciences assay","ALL","18 Years",{"count":19,"type":20},1978,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.",[26,27,28,29,30],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Estrogen Receptor-Positive Breast Carcinoma","HER2-Negative Breast Carcinoma","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":20},"2027-02-14",{"date":39,"type":20},"2029-07-31",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",59,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100053294","phase-3-adding-an-immunotherapy-drug-medi4736-durvalumab-to-the-usual-chemotherapy-treatment-paclitaxel-cyclophosphamide-and-doxorubicin-for-stage-ii-iii-breast-cancer-100053294","NCT06058377","Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer","Phase III Trial Of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone For Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive \u002F Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer","Inclusion Criteria:\n\n* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and\u002For progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines\n\n  * NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible\n* STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer\n\n  * NOTE: Participants with inflammatory breast cancer are eligible\n  * NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node\n* STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines\n* STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer\n* STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions\n\n  * NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued\n* STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status\n\n  * Submitting tissue for on-study MammaPrint testing:\n\n    * Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment\n\n      * NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR\n  * Submitting prior known MammaPrint Index Score:\n\n    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy\n\n      * NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network\n      * NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study\n      * NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment\n* STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy\n* STEP 1: REGISTRATION (SCREENING): Participants must be \\>= 18 years old at the time of registration\n* STEP 1: REGISTRATION (SCREENING): Participants must have body weight \\> 30 kg\n* STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2\n* STEP 1: REGISTRATION (SCREENING): Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 1: REGISTRATION (SCREENING): NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for Step 1 Registration\n* STEP 2: RANDOMIZATION: Participants must have MammaPrint High Risk 2 result\n\n  * For participants submitting tissue for on-study MammaPrint testing:\n\n    * Participants must be registered to Step 2: Randomization within 84 calendar days (12 weeks) after receiving an MP2 status from the MammaPrint Index score. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) from initial tumor biopsy OR\n  * Submitting commercial MammaPrint Index Score:\n\n    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy\n\n      * NOTE: Participants without a MammaPrint High-Risk 2 score must not be registered to Step 2 Randomization\n* STEP 2: RANDOMIZATION: Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed\n* STEP 2: RANDOMIZATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* STEP 2: RANDOMIZATION: Participant must have Zubrod Performance Status of 0-2\n* STEP 2: RANDOMIZATION: Participants must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within two years prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants must not have active autoimmune disease that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) prior to Step 2: Randomization. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 2: RANDOMIZATION: Participant must have a complete medical history and physical exam within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Leukocytes \\>= 3 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Total bilirubin =\\\u003C institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 × institutional ULN (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Participants must have a calculated creatinine clearance \\>= 50 mL\u002Fmin using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* STEP 2: RANDOMIZATION: Participants must not have uncontrolled diabetes defined as hemoglobin A1c of 9.0% or greater, within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants with history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have an undetectable viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained while on suppressive therapy within 6 months prior to Step 2: Randomization, if indicated\n* STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization, if indicated\n* STEP 2: RANDOMIZATION: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* STEP 2: RANDOMIZATION: Participants who can complete questionnaires in English, or Spanish must be offered the opportunity to participate in the Quality of Life study\n* STEP 2: RANDOMIZATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines",{"count":52,"type":20},3680,[23],"This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.",[26,56,30,57],"Anatomic Stage III Breast Cancer AJCC v8","Hormone Receptor-Positive Breast Carcinoma",{"date":34,"type":35},{"date":60,"type":35},"2023-11-27",{"date":62,"type":20},"2032-05-31",{"name":41,"class":42},543,{"id":66,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":24,"conditions":69,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":75,"locationsCount":76},"100623064",{"count":19,"type":20},[23],[26,27,28,29,30],"2026-07-01",{"date":72,"type":35},"2026-07-02",{"date":37,"type":20},{"date":39,"type":20},{"name":41,"class":42},36,{"id":78,"slug":4,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":54,"conditions":81,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":85,"locationsCount":86},"100520577",{"count":52,"type":20},[23],[26,56,30,57],{"date":72,"type":35},{"date":60,"type":35},{"date":62,"type":20},{"name":41,"class":42},541,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":94,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100491336","feasibility-study-of-biobehavioral-stress-reduction-intervention-in-patients-with-triple-negative-breast-cancer-100491336","NCT05677802","Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer","Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients","Inclusion Criteria:\n\n* Age \\>=18 years\n* Untreated newly diagnosed triple negative breast cancer\n* Stages I-III\n\nExclusion Criteria:\n\n* Prisoners\n* Male\n* Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander\n* Individuals not able to speak and understand English\n* Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer\n* Stage IV breast cancer","FEMALE",{"count":96,"type":20},40,[98],"NA","This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.",[101,26,56,30,102,103],"Anatomic Stage I Breast Cancer AJCC v8","Hormone Receptor-Negative Breast Carcinoma","Triple-Negative Breast Carcinoma","2026-06-24",{"date":106,"type":35},"2026-06-29",{"date":108,"type":35},"2022-12-14",{"date":110,"type":20},"2027-06-30",{"name":112,"class":113},"Ohio State University Comprehensive Cancer Center","OTHER",2,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100524736","mobile-health-for-adherence-in-breast-cancer-patients-100524736","NCT06112613","Mobile Health for Adherence in Breast Cancer Patients","Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)","Inclusion Criteria:\n\n* NON-PATIENT: Participants must be an oncology healthcare provider (i.e., oncologist, advanced practice provider, or oncology nurse)\n* NON-PATIENT: Participants must have taken care of at least one patient randomized to Arm B (CONCURxP) who had less than 85% adherence rate at 12 months as measured by the WiseBag\n* NON-PATIENT: Participant must speak English\n* NON-PATIENT: Participant must be employed at an National Cancer Institute Community Oncology Research Program (NCORP) site for at least 6 months\n* NON-PATIENT: Participant must be able to provide informed consent to participate in this study\n* PATIENT STEP 0: Patient must be \\>= 18 years of age\n* PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish\n* PATIENT STEP 0: Patient must present with new or established pathologically proven hormone receptor (HR)+ HER2- metastatic breast cancer at the time of Step 0\n* PATIENT STEP 0: Patient must have initiated any of the CKD4\u002F6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 30 days prior to consenting to Step 0 or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent\n\n  * NOTE: Patients who have been treated previously with anticancer treatments other than CDK4\u002F6 inhibitors are eligible\n  * NOTE: CDK4\u002F6 inhibitors must be provided\u002Fsupplied as a single agent blister pack. If the medication is supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible\n  * NOTE: Ribociclib (Kisqali) and abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4\u002F6 inhibitor that might be available in a capsule formulation. However, this is an outdated formulation and is rarely prescribed as a new start. The format of ordered palbociclib can be determined based on the prescription order\n* PATIENT STEP 0: Patients must not have been previously treated with any of the following CDK4\u002F6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio\n* PATIENT STEP 0: Patients must not already be enrolled in a therapeutic clinical trial that monitors CDK4\u002F6 inhibitors\n* PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at an NCORP site\n* PATIENT STEP 0: Patient must have a personal mobile phone in which they are able and willing to send and receive text messages\n\n  * NOTE: The restriction to those with mobile phone access with text messaging is based on the primary intention of the study which involves the use of text messaging to improve adherence\n* PATIENT STEP 0: Patient must have an email address\n\n  * NOTE: The restriction to those with an email address is based on the primary intention of the study which involves patients responding to questions regarding their reasons for non-adherence after every missed dose to improve adherence\n* PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document\n\n  * NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available are not eligible\n* PATIENT STEP 0: Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status \\>= 3 OR patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)\n* PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance\n\n  * NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance\n* PATIENT STEP 1: Patient must meet all the eligibility criteria for Step 0\n* PATIENT STEP 1: Patient must have signed a written informed consent form\n* PATIENT STEP 1: Patient must have completed baseline survey within 30 days of the date of Step 0 Registration\n* PATIENT STEP 1: Patients must have initiated their CDK 4\u002F6 inhibitors within 30 days of the date of Step 0 registration",true,{"count":124,"type":20},410,[98],"This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4\u002F6 inhibitor. To ensure CDK4\u002F6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4\u002F6 inhibitor.",[128,129,30,57],"Anatomic Stage IV Breast Cancer AJCC v8","Breast Carcinoma","2026-06-16",{"date":132,"type":35},"2026-06-18",{"date":134,"type":35},"2024-01-26",{"date":136,"type":20},"2027-07-31",{"name":138,"class":139},"ECOG-ACRIN Cancer Research Group","NETWORK",506,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":159,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":182},"100599536","phase-3-palazestrant-in-combination-with-ribociclib-for-the-first-line-treatment-of-erher2--advanced-breast-cancer-100599536","NCT07085767","Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)","OPERA-02","Inclusion Criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).\n* De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4\u002F6 inhibitors)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nExclusion Criteria:\n\n* Disease recurrence during adjuvant endocrine therapy\n* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.\n* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.\n* History of allergic reactions to study treatment.\n* Any contraindications to letrozole and ribociclib.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.",{"count":150,"type":20},1000,[23],"This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.",[154,155,156,157,158],"Breast Cancer","Locally Advanced Breast Cancer","Metastatic Breast Cancer","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma",[160,161,162,163,164,165,166,167,168,169,170,171,172],"Randomized","Multicenter","Double-Blind","Active-Controlled","Phase 3","Palazestrant","Complete Estrogen Receptor Antagonist (CERAN)","Selective Estrogen Receptor Degrader (SERD)","Ribociclib","CDK4\u002F6i","Letrozole","Aromatase inhibitors","Antineoplastic agents","2026-06-12",{"date":130,"type":35},{"date":176,"type":35},"2025-11-03",{"date":178,"type":20},"2032-01",{"name":180,"class":181},"Olema Pharmaceuticals, Inc.","INDUSTRY",150,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":94,"minAge":190,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":195,"conditions":196,"keywords":200,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100630102","phase-2-a-study-of-the-impact-of-endocrine-therapy-on-surgical-outcomes-in-people-with-lobular-breast-cancer-100630102","NCT07483307","A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer","Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study","Inclusion Criteria:\n\n* Written informed consent by participant or legally authorized representative\n* Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment.\n* Tumors of the ER+\u002FHER2- subtype, defined as:\n\n  1. ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei.\n  2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay.\n\nExclusion Criteria:\n\n* Patients with prior ipsilateral breast cancer.\n* Patients with advanced regional disease (cN2\u002FcN3) or stage 4 disease.\n* Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist.\n* Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease).\n* Patients with gadolinium allergy, precluding the use of breast MRI.","50 Years",{"count":192,"type":20},176,[194],"PHASE2","The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at the edges of tissue removed during surgery (positive margins).",[154,197,158,198,199],"HER2-negative Breast Cancer","ER+ Breast Cancer","Lobular Breast Carcinoma",[154,197,158,198,201,202,203],"26-095","Memorial Sloan Kettering Cancer Center","Lobular Breast Cancer","2026-06-02",{"date":206,"type":35},"2026-06-04",{"date":208,"type":35},"2026-03-13",{"date":210,"type":20},"2030-03-13",{"name":202,"class":113},7,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":94,"minAge":17,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":221,"phases":4,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100545914","divitumtka-a-biomarker-assay-for-efficacy-in-hr-breast-cancer-patients-100545914","NCT06388122","DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients","Inclusion Criteria:\n\n* Pre- or post-menopausal HR+ metastatic breast cancer patients who are:\n\n  * Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC).\n  * Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.\n  * Group 3: currently receiving 1st line therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.\n  * Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.\n  * Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4\u002F6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC\n\nNOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.\n\nExclusion Criteria:\n\n* Treatment including investigational agent or therapies\n* Early breast cancer diagnosis\n* Male breast cancer\n* Currently receiving treatment for other active malignancy at time of registration\n\n  * EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)\n* Inability to give written informed consent",{"count":220,"type":20},100,"OBSERVATIONAL","This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4\u002F6 inhibitor used for hormone receptor positive HER2 negative breast cancer.",[197,224,156,26,56,128,158,225,226],"Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Metastatic Breast Carcinoma","2026-05-28",{"date":229,"type":35},"2026-06-01",{"date":231,"type":35},"2024-04-30",{"date":233,"type":20},"2031-06-15",{"name":235,"class":113},"Mayo Clinic",1,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":248,"conditions":249,"keywords":253,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":212},"100568211","phase-1-a-study-of-abemaciclib-and-radiation-therapy-in-people-with-metastatic-breast-cancer-100568211","NCT06678269","A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer","A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Both male and female patients are allowed\n* Histologically confirmed metastatic breast cancer (mBC), current stage IV.\n* Plan for ablative radiotherapy (SBRT) to a bone metastasis.\n* Documented estrogen receptor (ER) positive and\u002For progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ER or PgR positive is ≥1% per ASCO\u002FCAP guidelines.\n* HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO\u002FCAP guidelines.\n* Any line of prior treatments (hormonal therapy and chemotherapy) is permitted including prior abemaciclib, palbociclib and ribociclib.\n* At the time of enrollment, treating physician has intent to resume abemaciclib (at any dose) following radiotherapy.\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy).\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. No prior radiotherapy to the current intended target site is permitted (ie. reirradiation is excluded from this study).\n* The patient must be able to swallow oral medications.\n* The patient must have adequate organ function per the following criteria (as defined in Table 2):\n\nTable 2: Laboratory Value Guidance to Establish Adequate Organ Function Hematologic ANC: ≥1.5 x 10\\^9\u002FL Platelets: ≥100 x 10\\^9\u002FL Hemoglobin: ≥8 g\u002FdL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n\nHepatic Total bilirubin: ≤1.5 x ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted ALT and AST: ≤3 x ULN\n\n* Patient may remain on hormonal therapy and abemaciclib before enrollment.\n* Patients must discontinue other CDK4\u002F6 inhibitor (palbociclib or ribociclib) for at least 7 days and recover from the acute effects of therapy (until the toxicity resolves to ≤Grade 1) except for residual alopecia and peripheral neuropathy.\n* Measurable or non-measurable disease is permitted as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) status of ≤2 or Karnofsky Performance Status (KPS) ≥60.\n* Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.\n* Women of childbearing potential must agree and commit to the use of a highly effective method of contraception as determined to be acceptable by the investigator, from the time of informed consent until 28 days after the last dose of the investigational product. Men must agree and commit to use a barrier method of contraception while on treatment and for 4 weeks after last dose of investigational products.\n* Patients (or their legally authorized representative) must provide written, informed consent to participate in the study and follow the study procedures\n* At the discretion of the treating radiation oncologist, radiation to a metastatic bone lesion is indicated inclusive of bone lesions in the spinal column.\n\nExclusion Criteria:\n\n* Treatment to bone lesions in the calvarium are not eligible for the dose-finding or expansion portions of the study. Patients who otherwise have calvarial lesions not undergoing treatment on this protocol are eligible to enroll.\n* Patients currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug\u002Fdevice used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to the start of study intervention, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* Patients who received radiation therapy ≤14 days prior to initiation of investigational agents are excluded.\n* Patients are ineligible if they have serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Females who are pregnant or lactating.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology screening).\n* Malignant spinal cord compression (ESCC2 or above)\n* Prior radiation therapy to the current target site.",{"count":245,"type":20},28,[247],"PHASE1","The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.",[156,250,154,251,252,197,158,224],"Stage IV Breast Cancer","Breast Cancer Stage IV","Breast Cancer Metastatic",[156,250,154,251,252,197,158,224,202,254],"24-138","2026-05-26",{"date":227,"type":35},{"date":258,"type":35},"2024-11-15",{"date":260,"type":20},"2028-11-30",{"name":202,"class":113},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":272,"conditions":273,"keywords":276,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":288,"locationsCount":236},"100614229","phase-2-preoperative-chemotherapy-pembrolizumab-and-low-or-high-dose-radiation-in-an-expansion-cohort-of-node-triple-negative-breast-cancer-100614229","NCT07276880","Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer","P-RAD(+)TN-DCT","Inclusion Criteria:\n\nIn order to participate in this study, a subject must meet all of the eligibility criteria outlined below.\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects are willing and able\n* to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* ECOG or Karnofsky Performance Status of 0 or 1\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy.\n* Pregnant or breastfeeding.\n* Prior ipsilateral invasive breast, chest wall or thoracic radiotherapy\n* Prior ipsilateral invasive breast cancer, contralateral breast cancer or a known\n* additional, invasive malignancy that is progressing or required active treatment in\n* the last 5 years",{"count":270,"type":20},32,[194],"This is a prospective radiation dose-finding, phase 2 expansion study of the Triple Negative (TN) cohort of the multicenter randomized study P-RAD (A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer; NCT04443348) that seeks to establish the optimal dose of radiation therapy (RT) to elicit an immune response when combined with immune checkpoint inhibitor (ICI) in breast cancer patients. Eligible subjects include women or men with operable, lymph node-positive, triple negative (TN) breast cancer who are candidates for standard of care neoadjuvant chemo-immunotherapy (NAC) based on the KEYNOTE-522 clinical trial. Thirty-two (n=32) patients will be randomized 1:1 to receive either low RT boost (9Gy total) or high RT boost (24Gy total). All RT will be delivered to the intact breast tumor in 3 daily fractions over 3 days.\n\nIn the Neoadjuvant Phase, the first cycle (C1) of pembrolizumab (200 mg i.v.) will be administered within 0-2 days of initiating RT. Participation in this study requires availability of residual diagnostic tissue biopsies of the primary tumor and metastatic lymph node for research use. If this tissue is not available, baseline research biopsies will be performed. Additionally, a research biopsy of the breast tumor and lymph node is required on Day 10-14 of C1 of pembrolizumab. After completion of the research biopsy in Week 2, the participants can commence standard-of-care neoadjuvant chemotherapy and pembrolizumab at the discretion of their medical oncology provider. After completing NAC, participants will undergo standard of care surgical resection of the breast and axillary lymph nodes, at the discretion of their surgical oncology provider. In the Adjuvant Phase, participants will receive standard of care adjuvant systemic therapy and standard of care adjuvant radiotherapy (if indicated), although recognizing that the breast tumor boost portion of this treatment has already been administered preoperatively. Except for late radiation adverse reactions of special interest, which will be followed yearly for up to 5 years, follow-up will occur every 6 months for 3 years.",[154,274,30,275],"Triple Negative Breast Cancer (TNBC)","Node-positive Breast Cancer",[277,278,279,280,281],"radiation therapy","neoadjuvant treatment","pembrolizumab","immune checkpoint inhibitor","radiotherapy boost","2026-04-24",{"date":284,"type":35},"2026-04-27",{"date":286,"type":35},"2026-03-17",{"date":178,"type":20},{"name":289,"class":113},"UNC Lineberger Comprehensive Cancer Center",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":297,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100519363","phase-2-dose-reduced-docetaxel-with-cyclophosphamide-for-the-treatment-of-vulnerable-older-women-with-stage-i-iii-her2-negative-breast-cancer-the-dorothy-trial-100519363","NCT06042569","Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial","Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY)","Inclusion Criteria:\n\n* Ability to provided informed consent or a legally authorized representative is able to consent on behalf of the patient\n* Willing to answer questionnaires as part of their participation\n* Age: \\>= 65 years by the time of study registration\n* Histologically or cytologically confirmed breast cancer(s) that is human epidermal growth factor receptor 2 negative (HER2-negative) per the most recent 2018 American Society of Clinical Oncology College of American Pathologists (ASCO CAP) guidelines relapsed\u002F refractory disease\n* Estrogen receptor and progesterone receptor immunohistochemistry (IHC) status must be known; any estrogen receptor (ER)\u002Fprogesterone receptor (PR) status is eligible\n* Non-metastatic, invasive breast cancer (scans are not required to document non-metastatic disease- any staging work-up is up to the treating providers' discretion)\n* Recommended to have either standard dose neoadjuvant docetaxel, cyclophosphamide (TC) chemotherapy or adjuvant TC chemotherapy per their treating provider. Participant may be on immunotherapy concurrently with the protocol regimen at the discretion of the treating physician\n* Any surgery, nodal assessment, radiation, hormonal therapy is left up to the treating provider but should not occur concurrently with study therapy\n* Any patient who received pre-operative hormonal therapy and who is then recommended for neo\u002Fadjuvant chemotherapy is eligible, though hormonal therapy should be held during study treatment administration\n* For patients with bilateral or multifocal\u002Fmulticentric breast cancers, the following criteria must be met to enroll: (1) both cancer are HER2 negative, AND (2) the provider feels the patient will benefit from TC for at least one of the cancers\n* Patients who do not speak or read English are eligible as long as adequate interpreter services are available or the surveys are available in the preferred language (i.e. the Geriatric Assessment \\[GA\\] and Patient Reported Outcomes \\[PRO\\] surveys are available in many languages)\n\nExclusion Criteria:\n\n* Participants who have already received any chemotherapy for their current breast cancer\n* Patients with recurrent and\u002For metastatic disease will be excluded. Prior diagnoses of breast cancers (including ductal carcinoma in situ \\[DCIS\\]) are allowed, provided that the treating provider feels that the current cancer most likely represents a new primary breast cancer and not recurrent disease\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide and\u002For docetaxel\n* Past treatment with the regimen TC for prior breast cancer","65 Years",{"count":299,"type":20},174,[194],"This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are commonly used, but is not well tolerated at the standard dose and can affect the way older patients feel physically and emotionally. Giving dose-reduced docetaxel combined with cyclophosphamide may be an effective treatment option and improve quality of life in vulnerable older women with stage I-III HER2 negative breast cancer.",[101,26,56,30],"2026-04-14",{"date":305,"type":35},"2026-04-17",{"date":307,"type":35},"2024-09-16",{"date":309,"type":20},"2030-03-20",{"name":311,"class":113},"City of Hope Medical Center",3,{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":94,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":21,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":236},"100550730","phase-2-turkey-tail-mushroom-for-treating-post-menopausal-women-with-her2-negative-er-positive-breast-cancer-undergoing-surgery-100550730","NCT06450873","Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery","A Phase 2 Pilot Window of Opportunity Study Turkey Tail Mushrooms (TTM) (Trametes Versicolor) in Post-Menopausal Women With HER2 (-) ER (+) Breast Cancer Planning to Undergo Surgical Therapy","Inclusion Criteria:\n\n* Women ≥ 18 years of age\n* Histological confirmation of ER+, HER2- breast cancer, newly diagnosed and tissue available for central confirmation of Ki-67 measurement. Subjects are eligible if they have a Ki-67 of ≥10%. Ki-67 will be repeated for patients who have had this done externally.\n* Scheduled for definitive breast surgery\n* Detectable disease as defined by mammography, breast ultrasound of greater than 5mm in size.\n\n  * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible\n* Post menopausal as defined by:\n\n  * Self-reported last menstrual period greater than 12 months, or\n  * Bilateral oophorectomy, or\n  * Follicle stimulating hormone (FSH) \\>20 mIU\u002FmL, and estradiol level ≤ 20 pg\u002FmL\n* Not taking aromatase inhibitor or a selective estrogen receptor modifier\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 obtained ≤ 90 days prior to registration\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 90 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3 (obtained ≤ 90 days prior to registration)\n* Hemoglobin ≥ 11 g\u002FdL (obtained ≤ 90 days prior to registration)\n* Serum transaminase \\[alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\\] ≤ 1.2 x upper limit of normal (ULN) (obtained ≤ 90 days prior to registration)\n* Alkaline phosphatase ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration)\n* Serum creatinine ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration)\n* Provide written informed consent\n* Ability to complete the Symptom Experience Diary by themselves or with assistance\n\nExclusion Criteria:\n\n* Ki-67 of \\\u003C10%\n* Current use of any medicinal mushrooms\n* Patient with locally advanced cancer who will require neoadjuvant therapy or metastatic cancer\n* Currently on systemic chemotherapy\n* Concurrent endocrine therapy (selective estrogen receptor modifiers or aromatase inhibitors)\n* Allergy to mushrooms\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients\n* Patients known to be HIV positive and currently receiving antiretroviral therapy.\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy 3 years prior to registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is a history of prior malignancy, they must not be receiving chemotherapy treatment for their cancer",{"count":96,"type":20},[194],"This phase II trial tests how well turkey tail mushroom (TTM) works in treating post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer undergoing surgery. TTM is a common mushroom. In traditional Chinese medicine, it is used for enhancing function and removing toxins, as well as for cancer, hepatitis, and infections. There is previous evidence of significant tumor shrinkage occurring in the 2-month window between diagnosis and surgery in women who have taken TTM. Giving TTM may be effective in treating post-menopausal women with HER2-negative, ER-positive breast cancer undergoing surgery.",[29,30],"2026-03-26",{"date":326,"type":35},"2026-03-31",{"date":328,"type":35},"2024-10-25",{"date":330,"type":20},"2028-04-30",{"name":235,"class":113},{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":353},"100517376","phase-3-op-1250-palazestrant-vs-standard-of-care-for-the-treatment-of-erher2--advanced-breast-cancer-100517376","NCT06016738","OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4\u002F6 Inhibitor Therapy (OPERA-01)","OPERA-01","Key inclusion criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease or bone-only disease).\n* Previously received a CDK4\u002F6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nKey exclusion criteria:\n\n* Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.\n* Previously received chemotherapy in the advanced\u002Fmetastatic setting.\n* Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.\n* History of allergic reactions to study treatment.\n* Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.\n* Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.",{"count":341,"type":20},510,[23],"This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4\u002F6 inhibitor.",[154,345,156,157,158],"Advanced Breast Cancer","2026-03-11",{"date":208,"type":35},{"date":349,"type":35},"2023-11-16",{"date":351,"type":20},"2027-09-30",{"name":180,"class":181},233,{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":94,"minAge":17,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":365,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":378},"100557131","acutherapy-to-prevent-aromatase-inhibitor-associated-arthralgias-in-non-hispanic-black-postmenopausal-women-with-early-stage-breast-cancer-100557131","NCT06534125","Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer","Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Self-identified Non-Hispanic Black woman\n* Postmenopausal status (\\>= 12 months since last menstrual period, history of bilateral salpingo-oophorectomy, or estradiol, follicle-stimulating hormone \\[FSH\\], and luteinizing hormone \\[LH\\] levels consistent with menopause)\n* Diagnosed with stage I-III HR+\u002FHER2 negative (-) breast cancer\n* Completed all phases of active therapy (e.g. surgery, chemotherapy, and\u002For radiation) at least 14 days before study enrollment\n* Planned to start adjuvant AI\n\nExclusion Criteria:\n\n* Diagnosed with metastatic breast cancer\n* Premenopausal status\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to acupuncture needles or other agents used in study\n* Diagnosis of rheumatoid arthritis, multiple sclerosis, or muscular dystrophy\n* A history of or current CDK 4\u002F6 inhibitor use\n* A history of neoadjuvant AI use\n* Use of adjuvant AI \\> 14 days\n* Received acupuncture within 60 days prior to start of study",{"count":182,"type":20},[98],"This clinical trial evaluates if in-person acupuncture or virtual acupressure therapy prevents aromatase inhibitor-associated joint pain in Non-Hispanic Black postmenopausal women with stage I-III (early-stage) hormone receptor positive (HR+) breast cancer. Aromatase inhibitors (AI) are medications that prevent the formation of the hormone estrogen. They are used in the treatment of postmenopausal women who have hormone-dependent breast cancer. AI therapy prolongs life among patients with early-stage HR+ breast cancer. Many postmenopausal women stop AI therapy early due to debilitating joint pain (arthralgias). Non-Hispanic Black women are more likely to experience side effects and stop their hormonal therapy compared to Non-Hispanic white women. Acupuncture therapy involves inserting thin needles through the skin at specific points on the body to control pain. Acupressure therapy uses the application of pressure or localized massage to specific sites on the body to control symptoms such as pain. Acupuncture and acupressure are types of complementary and alternative medicine. Undergoing in-person acupuncture or participating in virtual acupressure may prevent AI-associated arthralgias (AIAA) in Non-Hispanic Black postmenopausal women with early-stage HR+ breast cancer.",[101,26,56,30,57],[366,367,368],"Disparities","Health Equity","Health Services","2026-01-27",{"date":371,"type":35},"2026-01-29",{"date":373,"type":35},"2024-12-12",{"date":375,"type":20},"2027-12-31",{"name":377,"class":113},"Emory University",4,{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":389,"briefSummary":390,"conditions":391,"keywords":408,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":114},"100374021","phase-1-sharon-a-clinical-trial-for-metastatic-cancer-using-chemotherapy-and-patients-own-stem-cells-100374021","NCT04150042","SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells","SHARON: Study of Metastatic Cancers in Patients Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives","SHARON","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Pancreatic or breast cancer, as described below.\n* Stage IV (based on AJCC staging guidelines) at the time of enrollment.\n\n  a. Note that potential subjects with stage IV cancer that have had a complete response from prior chemotherapy are still potentially eligible.\n* Expected survival time ≥ 6 months, as determined by the investigator.\n* Life expectancy not severely limited by diseases other than malignancy, as determined by the investigator.\n* Karnofsky score ≥ 60%.\n* No chemotherapy within 2 weeks of enrollment.\n* Prior surgical resection or ablation of the primary tumor is allowed but not required.\n* If post-surgical, the subject must be at least 28 days post-op with the surgical wounds healed and significant complications resolved.\n* Potential subjects who have received previous chemotherapy and\u002For PARP inhibitors may be enrolled.\n* Measurable or non-measurable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1.\n* For potential subjects with a germline BRCA1, BRCA2, or PALB2 mutation:\n\n  a. The mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n* For potential subjects with somatic BRCA1, BRCA2, or PALB2 mutations:\n\n  1. The mutation must be a known or suspected deleterious mutation as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n  2. There must be biallelic loss or inactivation of the mutated BRCA1, BRCA2, or PALB2 gene as assessed by a CLIA-certified laboratory.\n  3. The Genetics Review Committee for this trial, which is comprised of a core group of investigators and whose actions are performed in accordance with the committee's charter, must agree that the biallelic mutations are deleterious or suspected deleterious.\n* For subjects without a BRCA1, BRCA2, or PALB2 mutation\n\n  1. Subject must have received at least 16 weeks of first-line (platinum-based\\*) chemotherapy with no evidence of treatment failure, where treatment failure is defined as growing tumors, new lesions, or a steadily rising tumor marker during or within eight weeks of completion of the first line therapy.\n  2. \\* Subjects can also have been treated with FOLFIRINOX but switched to FOLFIRI due to oxaliplatin side effects.\n* For potential subjects with pancreatic cancer:\n\n  1. Pancreatic ductal adenocarcinoma or pancreatic acinar cell carcinoma.\n  2. If the potential subject has had surgical resection of the primary tumor, then there must be no evidence of disease progression between the time of surgical resection of the primary tumor and screening for enrollment if the patient is seeking enrollment in the immediate post-surgery period.\n* For potential subjects with breast cancer:\n\n  1. Adenocarcinoma of the breast.\n  2. HER2-negative cancer as per American Society of Clinical Oncology\u002FCollege of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines.\n  3. Male or female sex.\n* Histological or cytological confirmation of the primary cancer diagnosis is required.\n* Metastatic disease must be histologically or cytologically confirmed unless in the clinical judgment of the investigator a biopsy is not needed for diagnostic purposes.\n* Female participants of childbearing potential must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n  1. Simultaneously practice two effective barrier methods of contraception. Oral and injectable contraceptives are not allowed. Barrier methods of birth control (e.g., diaphragm and spermicide, or condom and spermicide) are required.\n  2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n* Male participants:\n\n  1. Unless the male is in a monogamous relationship with a female that does not have child-bearing potential, male subjects (even if surgically sterilized) must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n     1. Practice effective barrier contraception, plus a second method of effective contraception.\n     2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n\nExclusion Criteria\n\n* Rapid disease progression or clinical features concerning for onset of rapid symptomatic deterioration, as determined by the investigator.\n* Biliary tract obstruction.\n* Current cholangitis. A biliary stent in situ does not otherwise exclude protocol participation.\n* A history of only one episode of cholangitis and fewer than 30 days have passed since discontinuation of antibiotic treatment.\n* A history of multiple episodes of cholangitis and after discussion between the site study team and sponsor medical monitor and careful evaluation for suitability the patient is deemed to be unsuitable for the trial due to risk of recurring cholangitis.\n* Portal hypertension.\n* Sinistral portal hypertension.\n* Obliteration or significant obstruction of the major veins or arteries (e.g., portal vein, superior mesenteric artery, superior mesenteric vein).\n* Clinically significant malignant ascites or malignant pleural effusion, as determined by the investigator.\n* Metastatic lesion to the heart or eye.\n* Chemotherapy for an indication other than treatment of the current cancer within the past 1 year with a more than 30% risk of recurrence as determined by the investigator.\n* Known or suspected metastatic involvement of the central nervous system.\n* Left ventricular ejection fraction less than 45% by Multigated Acquisition Scan or echocardiogram (or significantly below the lower limit of normal for the specific test).\n* Clinically significant structural heart disease or vascular disease.\n* Myocardial infarction within 6 months prior to enrollment; New York Heart Association (NYHA) Class III or IV heart failure; angina; uncontrolled ventricular arrhythmias; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n* Clinically significant prolongation of QTc (Bazett formula) on EKG, defined as \\> 0.45 s in males and \\> 0.47 s in females.\n* Severe hypertension, which is defined as the presence of any of the following:\n\n  1. History of hypertensive crisis, hypertensive emergency, or malignant hypertension within the last year.\n  2. Sustained or persistent systolic BP \\> 165 mm Hg or diastolic \\> 110 mm Hg.\n* Other clinically significant cardiovascular disease.\n* NOTE:\n\n  1. A past history of severe hypertension that is well-controlled with therapy or that was addressed by removal of the cause (e.g., removal of a medicine that caused the severe hypertension) is not an exclusion criterion.\n  2. The presence of a pacemaker is not a contraindication and is not considered an exclusion criterion\n* History or evidence of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis).\n* If a smoker, refusal to stop smoking for the duration of the trial.\n* FEV1 or DLCO (adjusted for hemoglobin) \\\u003C 50% of predicted.\n* Total bilirubin \\> 2x upper normal limit, except that potential subjects with Gilbert's Disease are permitted to exceed 2x upper normal limit.\n* ALT or AST \\> 2.5x upper normal limit.\n* Alkaline phosphatase \\> 2.5x upper normal limit, in conjunction with elevated GGT.\n* Albumin \\\u003C 3.0 g\u002Fdl.\n* Clinical evidence of sinusoidal obstruction syndrome.\n* Corrected creatinine clearance consistently \\\u003C 50 ml\u002Fmin\u002F1.73 m\\^2.\n* Clinically significant renal disease.\n* Hemolytic anemia.\n* Family history of catalase deficiency or history or evidence of a severe adverse reaction to hydrogen peroxide consistent with catalase deficiency, unless testing has demonstrated that the patient is not catalase-deficient.\n* Evidence of bone marrow insufficiency or failure, in the judgment of the investigator.\n* A hemoglobin \\\u003C 9 g\u002FdL.\n* G6PD deficiency as measured by quantitative enzyme levels below the normal reference range in blood.\n* Pre-existing bleeding diathesis or coagulopathy.\n* Potential subject is pregnant.\n* Breast feeding and unwilling to stop.\n* Wilson's disease.\n* Primary or secondary hemochromatosis.\n* Hgb A1c \\> 9%.\n* Hyperuricemia that is not responsive to therapy.\n* Plasma oxalate greater than 10 µM, which is not responsive to measures to reduce the level below 10 µM.\n* History of clinically significant elevation of plasma oxalic acid or complications related to oxalic acid.\n* Prior or current hepatitis B or C.\n* HIV infection or seropositivity for HIV.\n* Active, clinically significant bacterial, viral, or fungal infection.\n* History of colonization with a multidrug-resistant \"superbug\" that poses a high risk of an untreatable infection in the setting of neutropenia.\n* Uncontrolled seizure disorder.\n* If a potential subject has received radiation, then any of the following:\n\n  1. A volume ≥ 700 ml of normal liver received a dose ≥ 10 Gy.\n  2. The mean dose to normal liver (i.e., liver minus gross tumor volume) was ≥ 10 Gy.\n  3. The mean dose to normal lung (i.e., lung minus gross tumor volume) was ≥ 4 Gy.\n* History of significant allergy or other contraindication to BCNU, melphalan, vitamin B12b, vitamin C, pegfilgrastim, or Neupogen, or to any excipient in those drugs.\n* Use of any of the following cytochrome P450 2b6 (CYP2b6) inducers within 21 days of the planned date of BCNU treatment: phenobarbital, carbamazepam, rifampicin, phenytoin, sulfinpyrazone, or verapamil.\n* Disulfiram (Antabuse) use within 30 days of the planned ethanol administration.\n* Current chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids).\n* Prior bone marrow stem cell transplant.\n* Except for adjuvant therapy for breast cancer or pancreatic cancer, prior radiation therapy to the brain, kidneys, pelvis, or GI tract or treatment with yttrium-90.\n* Prior treatment with bleomycin or BCNU.\n* Prior treatment, within 30 days of enrollment, with a drug that has not been FDA-approved for any indication (cancer or otherwise).\n* Subject has not fully recovered (i.e., there remain toxicities \\> Grade 1) from the reversible effects of prior chemotherapy, with the exception of chemotherapy-induced alopecia and grade 2 peripheral neuropathy, unless in the opinion of the principal investigator the effects are not of clinical significance.\n* Any concurrent anticancer treatment.\n* Serious underlying medical or psychiatric illness or another condition that in the clinical judgment of the principal investigator is likely to interfere with the potential subject completing participation in the trial, based on safety concerns or otherwise.\n* Inability or unwillingness to adhere to the study protocol.\n* Unwillingness to receive ethanol.",{"count":388,"type":20},24,[247],"The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.",[392,393,394,395,396,397,398,399,252,251,400,197,158,401,402,403,404,405,406,407],"Pancreatic Adenocarcinoma Metastatic","BRCA1 Mutation","BRCA2 Mutation","Pancreatic Acinar Cell Carcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer","Metastatic Pancreatic Cancer","Metastatic Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer Stage IV","Adenocarcinoma of the Breast","PALB2 Gene Mutation","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Pancreas Cancer","Stage IV Pancreatic Cancer","Stage 4 Pancreatic Cancer",[409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434],"pancreatic adenocarcinoma","pancreatic cancer","BRCA","BRCA1","BRCA2","melphalan","BCNU","carmustine","vitamin C","vitamin B12b","autologous stem cell infusion","stage 4 pancreatic cancer","metastatic pancreatic cancer","pancreatic acinar cell carcinoma","pancreatic ductal adenocarcinoma","PDAC","breast cancer","stage 4 breast cancer","stage IV pancreatic cancer","stage IV breast cancer","stem cells","HER2-negative breast cancer","PALB2","metastatic breast cancer","BRCA pancreatic cancer","BRCA breast cancer",{"date":371,"type":35},{"date":437,"type":35},"2021-01-13",{"date":439,"type":20},"2028-12",{"name":441,"class":181},"General Oncology, Inc.",{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":450,"targetDuration":451,"studyType":221,"phases":4,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":236},"100575572","prospective-registry-of-adc-as-first--and-second-line-treatment-for-breast-cancer-100575572","NCT06774027","Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer","ENCORE: Multicenter ProspectivE Registry of Sequential ANtibody Drug COnjugates (ADCs) in HER2 Negative Metastatic BREast Cancer (MBC)","ENCORE","Inclusion Criteria:\n\n1. Male or female patients aged 18 years or greater with ability to provide written informed consent for this prospective registry study.\n2. Estimated life expectancy of at least at 3 months per investigator assessment.\n3. Willingness to provide an archival tissue sample and blood samples (20cc research blood collection at several timepoints) for research purposes.\n4. Cohort-specific enrollment criteria:\n\n   * Cohort 1: Histologically documented HR+\u002FHER2- MBC with plan to start an FDA-approved ADC as their first ADC per standard of care (SOC).\n   * Cohort 2: Histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their first ADC per standard of care\n   * Cohort 3: Histologically documented HR+\u002FHER2- MBC with plan to start an FDA-approved ADC as their second ADC per standard of care (ADC1 should be an approved ADC administered per SOC or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review.\n   * Cohort 4: Histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per standard of care (ADC1 should be an approved ADC administered per standard of care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review.\n   * Measurable disease is not required for any cohort.\n\nExclusion Criteria:\n\n1. Prior receipt of an experimental ADC in the metastatic setting. Of note, patients who received an FDA-approved ADC as their first ADC (as monotherapy, not in combination) can participate in cohorts 3 or 4 prior to starting their second FDA-approved ADC per standard of care. Of note, for all cohorts, experimental therapies are not allowed as intervening therapies after starting ADC1. If a patient enrolls on a clinical trial of an experimental therapy after ADC1, they will be taken off study.\n2. Current participation in a clinical trial with an ADC.\n3. Contraindication to research phlebotomy to collect \\~20cc blood at each research blood draw timepoint.",{"count":220,"type":20},"5 Years","Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC) and hormone receptor positive\u002FHER2 negative (HR+\u002FHER2-) metastatic breast cancer (MBC), offering an effective new treatment strategy. Several outstanding questions drive the decision to use ADC drugs clinically. This is a prospective, multi-site observational study of patients with metastatic breast cancer (mBC) who are being treated with FDA-approved antibody drug conjugates (ADCs) as part of routine care and aims to collect real-world data to evaluate the impact of ADC treatment as part of routine care.",[197,158,156,454,455,456],"HR+ HER2 Breast Cancer","Metastatic Triple Negative Breast Cancers","Metastatic Triple-Negative Breast Carcinoma","2025-12-10",{"date":459,"type":35},"2025-12-18",{"date":461,"type":35},"2025-10-08",{"date":463,"type":20},"2030-12-31",{"name":465,"class":113},"University of California, San Francisco",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":21,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":236},"100464431","neoadjuvant-breast-cancer-time-restricted-eating-100464431","NCT05327608","Neoadjuvant Breast Cancer Time Restricted Eating","Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy","Inclusion Criterion\n\nIndividuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n\n1. Patient must be ≥ 18 years of age at time of consent and must be able to understand and provide informed consent.\n2. BMI 25-40 at time of enrollment.\n3. Patients must have an ECOG performance status of 0 or 1.\n4. Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma.\n\n   1. Multifocal or contralateral DCIS or invasive breast cancers are allowed if the breast cancers meet the same eligibility criteria for ER\u002FPR and HER2.\n   2. Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy.\n5. Tumor status must be HER2 negative per ASCO\u002FCAP guidelines (determined by local testing).\n6. Patients must have clinical stage I-III (utilizing TNM criterion) at diagnosis.\n7. Clinical T size must be ≥ 1.5cm if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved.\n8. Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy.\n\n   a. Acceptable regimen includes doxorubicin and cytoxan followed by a taxane The schedule will be determined by treating physician. Carboplatin and pembrolizumab can also be added to the neoadjuvant chemotherapy regimen if determined to be appropriate by treating physician.\n9. Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician.\n10. Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks\n11. Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention.\n12. Patient must have a personal email address, an internet-capable device, and the ability\u002F willingness to read and reply to email every day for the duration of the study.\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Clinical T4 and\u002For N3 disease, including inflammatory breast cancer.\n2. Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy.\n3. Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention.\n4. Patients with type 1 diabetes, or type 2 diabetes treated with insulin.\n5. Patients with a history of eating disorder or taking weight loss medications\n6. Patients who actively smoke\n7. Patients who work night shifts or on a rotating shift schedule.\n8. Patients must not have impaired decision-making capacity.\n9. Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool.\n10. Patients that are \\>2 weeks into starting neoadjuvant chemotherapy regimen.",{"count":474,"type":20},55,[98],"A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+\u002F- 5 days) by the research team during their clinic visit.",[101,26,56,478,158,225,479],"Breast Ductal Carcinoma in Situ","Invasive Breast Carcinoma","2025-07-30",{"date":482,"type":35},"2025-08-01",{"date":484,"type":35},"2022-07-28",{"date":486,"type":20},"2027-05-01",{"name":488,"class":113},"Thomas Jefferson University",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":21,"phases":498,"briefSummary":499,"conditions":500,"keywords":503,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":312},"100529629","phase-2-dato-base-datopotamab-deruxtecan-for-breast-cancer-brain-metastases-100529629","NCT06176261","DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","Inclusion Criteria :\n\n* Metastatic breast cancer that is pathologically confirmed to be HER2-negative according to 2018 ASCO\u002FCAP guidelines 55.\n* Radiological confirmation of metastatic disease.\n* Cohorts A and B: Presence of newly diagnosed brain metastases or brain metastases progressing after prior local and\u002For systemic therapy.\n* Cohorts A and B: Participants must have a baseline MRI of the brain performed with and without gadolinium contrast, and must have central nervous system metastases with at least one measurable brain metastasis ≥ 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy and\u002For systemic therapy (in the opinion of the treating physician). For cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.\n* Cohorts C: Radiological evidence of evaluable leptomeningeal disease and clinical diagnosis of LMD per treating investigator. A positive CSF cytology is not required.\n* Cohort A: prior progression to treatment with at least one line of endocrine treatment (with or without CDK4\u002F6 inhibition) in the metastatic setting is mandatory. Patients experiencing recurrence during adjuvant endocrine treatment will be also considered eligible for the trial. There is no limit on the number of prior lines acceptable for the purpose of enrollment in this study.\n* Cohort B and C: no prior treatment is required (i.e., previously untreated patients are eligible). There is no limit on the number of prior lines of therapy acceptable for the purpose of enrollment in this study.\n* Participants may have measurable or non-measurable extracranial disease. Participants are NOT required to have extracranial disease, but must have imaging done to document disease status at baseline.\n* Age ≥ 18 years.\n* ECOG Performance Status 0-2\n* Participants must have adequate treatment washout period before registration, defined as \\> 4 weeks from major surgery, \\> 2 weeks from radiation treatment. For weekly chemotherapy regimens, \\> 2 weeks from chemotherapy; for every 3 weekly regimens, \\> 3 weeks from chemotherapy. At least 2 weeks from other systemic or targeted or investigational therapies (other than endocrine therapy) for breast cancer. No washout is required for endocrine therapy (e.g. aromatase inhibitors, tamoxifen, fulvestrant) but patients should discontinue prior to start of protocol therapy. Patients on ovarian suppression are allowed (but not required) to continue ovarian suppression at the discretion of their treating provider.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n* Adequate organ function as defined by the following values:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL. Red blood cell\u002Fplasma transfusion is not permitted within 1 week prior to screening assessment.\n  * Absolute neutrophil count ≥1,500\u002Fmm3. Granulocyte colony-stimulating factor administration is not permitted within 1 week prior to screening assessment.\n  * Platelets ≥100,000\u002Fmm3. Platelet transfusion is not permitted within 1 week prior to screening assessment.\n  * Total bilirubin ≤ 1.5 institutional ULN if no liver metastases; or ≤ 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN OR ≤ 5.0 x institutional ULN for patients with documented liver metastases\n  * Serum creatinine ≤ 1.5 mg\u002FdL (or glomerular filtration rate ≥ 30 ml\u002Fmin as determined by the Cockcroft-Gault equation)\n* Participants with a history of chronic viral conditions such as HIV, Hepatitis B\u002FC, should not be systemically excluded but have thoughtful consideration of inclusion, unless safety is a concern. Testing for these conditions is not required at baseline.\n* Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 14 days of initiating protocol therapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Visceral crisis or impending visceral crisis\n* CNS complications for whom urgent neurosurgical intervention is indicated (i.e., resection, shunt placement)\n* Indication for immediate local therapy to CNS lesion(s) as defined by local standard\n* Evidence of significant (i.e., symptomatic) intracranial hemorrhage\n\n  -\\> 2 seizures within 4 weeks prior to study entry (registration)\n* Ongoing\u002Fpersistent toxicities caused by previous anti-cancer therapy (except alopecia) not yet improved to Grade ≤ 1 OR baseline prior to study entry (registration)\n* Known contraindication to MRI (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitivity). However, for cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.\n* Concurrent administration of other anti-cancer therapy during the course of this study is not allowed. Concurrent use of supportive care medications is allowed, and certain medications are required (see Section 5.1).\n* Uncontrolled intercurrent illness, including (but not limited to) active infection, severely compromised pulmonary function, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ischemic heart disease, myocardial infarction within the previous six months, gastric or duodenal ulceration diagnosed within the previous six months, chronic liver or renal disease, or severe malnutrition. Note that if a patient has controlled diabetes mellitus, but is unable to monitor blood glucose at home, they will be excluded from the trial.\n* Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (\\>4 mg daily dexamethasone (or bioequivalent)) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain ≤ 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion.\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* A history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.\n* A history of malignancy other than breast cancer, except (a) adequately resected non-melanoma skin cancer, (b) curatively treated in situ disease, or (c) other solid tumors curatively treated, with no evidence of disease for ≥ 3 years.\n* Major surgery, open biopsy, or significant traumatic injury within 28 days prior to the initiation of protocol therapy, or anticipation of need for a major surgical procedure during the study.\n* Clinically significant corneal disease.\n* Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of datopotamab deruxtecan.\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Negative pregnancy test (urine and\u002For serum) is required for women of childbearing potential. Pregnant or lactating women are excluded from participation due to potential teratogenic effects of study drug.\n* Female participants must be either:\n\n  * post-menopausal for at least 1 year\n  * surgically sterile, or\n  * if of childbearing potential and sexually active with a non-sterilized male partner, must agree to use one highly effective form of birth control for the entire treatment period and for at least 7 months after the last dose of datopotamab deruxtecan (see Section 5.4 for complete list of highly effective birth control methods).\n* Female participants must not donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of datopotamab deruxtecan.\n* Female participants must refrain from breastfeeding while on study and for at least 7 months after the last dose of datopotamab deruxtecan.\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception (see Section 5.4 for complete list of highly effective birth control methods) from the time of screening throughout the total duration of the study and the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.",{"count":497,"type":20},58,[194],"The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain.\n\nThe name of the study drug used in this research study is:\n\nDatopotamab deruxtecan (a type of antibody-drug conjugate)",[154,501,456,157,197,158,502],"Breast Cancer Female","ER-negative Breast Cancer",[154,501,456,157,504,158,505],"HER2 Negative Breast Cancer","ER Negative Breast Cancer","2025-07-28",{"date":480,"type":35},{"date":509,"type":35},"2024-01-08",{"date":511,"type":20},"2029-01-01",{"name":513,"class":113},"Sarah Sammons, MD",{"id":515,"slug":516,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":236},"100518139","phase-1-gemcitabine-and-ex-vivo-expanded-allogenic-universal-donor-tgfi-natural-killer-nk-cells-with-or-without-naxitamab-danyelza-for-the-treatment-of-patients-with-metastatic-gd2-expressing-her2-negative-breast-cancer-100518139","NCT06026657","Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer","Phase 1b\u002F2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs)","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed, HER2 negative metastatic breast cancer that is historically GD2 expressing (e.g., triple negative breast cancer, metaplastic breast cancer, high grade 3 estrogen positive breast cancer at initial diagnosis) with available archival tissue. Well differentiated neuroendocrine tumor (NETs) are not eligible for this trial since GD2 expression is unknown. GD2 expression is not required for eligibility but a primary tumor paraffin block is required at enrollment for assessment of GD2 expression\n* Patients must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for the evaluation of measurable disease\n* Patients must have received at least one prior treatment for metastatic disease and progressed on treatment or been intolerant to treatment\n* Female or male \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Absolute neutrophil count \\>= 1,500\u002FmcL (\\> 1.5 X 10\\^6\u002FL)\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 9 mg\u002FdL (transfusion to obtain hemoglobin \\>= 9 mg\u002FdL within 24 hours prior to dosing is allowed)\n* Serum creatinine =\\\u003C 1.5 X upper limit of normal (ULN) or measured or calculated creatinine clearance (CrCl) \\>= 60 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional upper limit of normal (ULN) (Glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or CrCl)\n* Patients must have adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels =\\\u003C 3 X ULN and total bilirubin \\\u003C 1.5 X ULN, unless known diagnosis of Gilbert's syndrome, where bilirubin =\\\u003C 5 mg\u002FdL will be permitted. Gilbert's syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total. Total bilirubin will be permitted up to 5 mg\u002FdL, if patients have historical readings consistent with the definition of Gilbert's syndrome prior to entering study. Adequate hepatic function for patients with known liver metastases is defined as AST and ALT levels ≤ 5 X ULN\n* The effects of the trial agents on the developing human fetus are unknown. However, gemcitabine is known to have negative fetal effects. For this reason: Women of childbearing potential must agree to use adequate contraception at study entry, for the duration of study participation and for 7 months after the last dose of study medication based upon estimated half-life or receptor occupancy. Adequate contraception is defined as 2 highly effective methods of contraception (including a physical barrier). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men should refrain from fathering a child using adequate contraception or donating sperm during the study and for 6 months after the last dose of study medications. Adequate contraception is defined as 2 highly effective methods of contraception (including a physical barrier)\n* Patients with well-controlled human immunodeficiency virus (HIV) infection are eligible for trial as long as:\n\n  * On an effective anti-retroviral therapy (ART) ˃ 4 weeks and with evidence of viral-suppression as defined as HIV viral load ˂ 400 copies\u002FmL within the last 3 months\n  * CD4 \\> 200 cells\u002FµL within the last 3 months; and\n  * No reported opportunistic infections within 6 months prior to enrollment, except for the following which will be allowed:\n\n    * Esophageal candidiasis treated within last 6 months or currently improving with antifungal treatment.\n    * Oral and\u002For genital herpes simplex virus (HSV) treated within last 6 months or currently improving with antiviral treatment.\n    * Mycobacterium avium infection in last 6 months or that has been treated for at least 1 month\n* Patients with evidence of chronic hepatitis B virus (HBV) infection are eligible for trial as long as the HBV viral load is undetectable on suppressive therapy, if indicated.\n\n  * Patients with history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable or unquantifiable HCV ribonucleic acid (RNA) 12 weeks or longer after definitive treatment completion.\n  * Patients must be able to understand and willing to sign a written informed consent document\n* Any adverse events subjects have experienced from prior therapy must have resolved to =\\\u003C grade 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5\n\nExclusion Criteria:\n\n* Patients who within 3 weeks prior to study enrollment who have received chemotherapy, investigational agents, or radiation\n* Patients with active brain metastases or leptomeningeal metastases are excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, patients with treated brain metastases are eligible if there is no magnetic resonance imaging (MRI) evidence of progression for 6 months after treatment is complete and within 28 days prior to the first dose of trial drug. Patients requiring immunosuppressive doses of systemic corticosteroids (\\> 10mg\u002Fday prednisone equivalent) for palliation are excluded\n* Patients with a history of another invasive malignancy \\\u003C 3 years prior to enrollment (patients with non-melanoma skin cancers, carcinoma in situ of the breast or cervix are eligible)\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing active infection that requires systemic treatment with ongoing antibiotics (eligible if can stop antibiotics on day of enrollment), unexplained fever (temperature \\> 38.1˚celcius \\[C\\]) within 7 days of initial treatment, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situation that in the opinion of the primary investigator would prohibit the patient from complying with study requirements\n* Patients with bone metastases who have initiated denosumab or a bisphosphonate therapy within 28 days prior to or after cycle 1 day 1 due to the potential for flu-like symptoms and mild cytokine release syndrome with the initial dose. However, continuation of prior therapy is allowed\n* Patients should have no evidence of being immunocompromised as listed below:\n\n  * Active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger in the opinion of the primary investigator\n  * Altered immune function that in the judgement of the PI that may affect a patient's ability to adequately engage the immune system and respond to the immunotherapy agents being administered, including but not limited to: inflammatory bowel disease; active infectious enteritis; eosinophilic enteritis; lupus erythematous; ankylosing spondylitis; scleroderma; multiple sclerosis. These criteria do not include all disease with an immune-related component but are not autoimmune in nature or have a primary alteration in the general immune function that may interfere with the vaccine mechanism of action, for example celiac disease\n  * Immunosuppressive therapy post-organ transplant\n  * Concurrent use of chronic use of systemic steroids, except for physiologic doses of systemic steroids for replacement, defined as 10mg of prednisone per day or equivalent, or local (topical, nasal, ophthalmic or inhaled) steroid use or prior concomitant use with chemotherapy. Systemic steroids must have been discontinued \\>2 weeks prior to trial start. Prior use of corticosteroids in short-term schemes (duration shorter than 3 days) for indications such as prophylaxis of reactions to intravenous contrast for imaging studies or chemotherapy-related adverse events (AEs) are not considered part of this exclusion. Prior use of corticosteroids for brain metastasis ending at least 14 days prior to enrollment is not considered part of this exclusion criteria\n* Pregnant and breastfeeding women are excluded from this study because of the potential for teratogenic or abortifacient effects with all of the agents involved in this trial. Females of childbearing potential who are pregnant, breast feeding, intend to become pregnant, or are not using adequate contraceptive methods or males who are not using adequate contraceptive methods. Women of childbearing potential must agree to use two methods of adequate contraception at study entry be used for the duration of study participation and for at least 7 months for women and 6 months for men after the final dose of any study-related medications\n* Clinically significant cardiomyopathy, coronary disease, myocardial infarction, chronic heart failure (CHF) (New York Heart Association class III or IV or hospitalization for CHF), ejection fraction \\\u003C 50% or cerebrovascular accident within 6 months prior to enrollment\n* Patients with a history of myocarditis are excluded due to the potential of myocarditis with anti-PD-L1 antibodies or other immunotherapies\n* Patients who have received any live vaccines within 30 days prior to enrollment (inactivated vaccines including COVID vaccines are allowed)\n* Any other condition, which would, in the opinion of the principal investigator the subject is a poor candidate for the clinical trial or would jeopardize the subject or the integrity of the data obtained\n* Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and\u002For chronic oxygen requirement. In addition, room air pulse oximetry \\\u003C 90% and\u002For abnormal pulmonary function tests within 28 days of C1D1 if these assessments are clinically indicated.",{"count":522,"type":20},42,[247,194],"This phase Ib\u002FII trial tests the safety, best dose and how well gemcitabine and ex vivo expanded allogenic universal donor TGFBi NK cells with or without naxitamab work for the treatment of patients with GD2 expressing, HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. TGFBi NK cells are manufactured cells that are a part of your natural immunity. NK cells can recognize missing or incorrect proteins on tumor cells and then eliminate these tumor cells and TGFBi NK cells are created to be able to better kill the tumor cells. Naxitamab is a monoclonal antibody that targets GD2, which is a protein or sugar present on tumor cells but not very commonly found on normal cells. This antibody helps draw the attention of the immune system to the tumor cells that have GD2 to help attack the tumor cells. Giving gemcitabine and TGFBi NK cells with or without naxitamab may kill more tumor cells in patients with metastatic GD2 expressing, HER2 negative breast cancer.",[128,30],"2025-07-02",{"date":528,"type":35},"2025-07-08",{"date":530,"type":35},"2024-04-02",{"date":532,"type":20},"2026-12-31",{"name":534,"class":113},"Margaret Gatti-Mays",{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":94,"minAge":17,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":21,"phases":543,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":378},"100474969","early-phase-1-letrozole-with-and-without-simvastatin-for-the-treatment-of-stage-i-iii-hormone-receptor-positive-her2-negative-breast-cancer-100474969","NCT05464810","Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer","A Randomized Window of Opportunity Study of Preoperative Letrozole and Simvastatin Versus Letrozole Alone in Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Biopsy proven hormone receptor positive, HER2 negative stage I-III invasive breast cancer\n\n  * Estrogen receptor (ER) and\u002For progesterone receptor (PR) positivity are defined as \\>= 10% of cells expressing hormonal receptors via IHC analysis\n  * HER2 negativity is defined as either of the following by local laboratory assessment\n\n    * IHC 0, 1+, or 2+ and in situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \\\u003C 2.0 or single probe average HER2 gene copy number \\\u003C 4 signals\u002Fcell)\n* Minimum primary tumor size 5 mm on any breast imaging (mammogram, ultrasound, magnetic resonance imaging \\[MRI\\])\n* Baseline Ki-67 IHC expression on tumor tissue \\>= 10%\n* Post-menopausal women\n\n  * Prior bilateral oophorectomy\n  * Age \\>= 55 years\n  * Age \\\u003C 55 and amenorrheic for 12 months or more in the absence of chemotherapy, endocrine therapy, or ovarian suppression and follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol in the postmenopausal range\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Prior treatment:\n\n  * No systemic therapy (chemotherapy, immunotherapy, endocrine therapy, and\u002For investigational therapy) within 3 months of trial enrollment\n* No statins, fibrates, or ezetimibe within 3 months of trial enrollment\n* No active liver disease\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: the use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 9.0 g\u002Fdl is acceptable) (within 14 days prior to initiation of study treatment)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (after at least 7 days without growth factor support or transfusion) (within 14 days prior to initiation of study treatment)\n* Platelets \\>= 100,000\u002FmcL (within 14 days prior to initiation of study treatment)\n* Total bilirubin =\\\u003C 2 institutional upper limit of normal (ULN) (within 14 days prior to initiation of study treatment)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 institutional ULN (within 14 days prior to initiation of study treatment)\n* Serum creatinine =\\\u003C 2 mg\u002FdL (or glomerular filtration rate \\>= 40 mL\u002Fmin) (within 14 days prior to initiation of study treatment)\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions\n* Be willing and able to provide written informed consent for the trial\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents or an investigational device within 3 months before administration of first dose of study drugs\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to simvastatin and\u002For letrozole\n* Concomitant use of strong CYP3A4 inhibitors (i.e. clarithromycin, erythromycin, itraconazole, ketroconazole, nefazodone, Posaconazole, voriconazole, protease inhibitors \\[including boceprevir and telaprevir\\], telithromycin, cobicistat-containing products), cyclosporine, danazol, and gemfibrozil\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, substance abuse disorders, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade \\>= 3 hypertension (diastolic blood pressure \\>= 100 mmHg or systolic blood pressure \\>= 160 mmHg) despite antihypertensive therapy\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy",{"count":96,"type":20},[544],"EARLY_PHASE1","This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. Letrozole and simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The addition of simvastatin to letrozole may be more effective at stopping the growth of cancer cells than letrozole alone.",[101,26,56,30,57,479],"2025-05-20",{"date":549,"type":35},"2025-05-23",{"date":551,"type":35},"2022-09-02",{"date":553,"type":20},"2027-04-15",{"name":377,"class":113}]