[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-receptor-positive-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-receptor-positive-breast-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,43,55,85,110,136,161,192,214,248,272,309,336,354,378,401,421,442],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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",false,"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","ALL","18 Years",{"count":19,"type":20},3680,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","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.",[26,27,28,29],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","HER2-Negative Breast Carcinoma","Hormone Receptor-Positive Breast Carcinoma","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2023-11-27",{"date":38,"type":20},"2032-05-31",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",543,{"id":44,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":21,"phases":46,"briefSummary":24,"conditions":47,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":51,"completionDateStruct":52,"leadSponsor":53,"locationsCount":54},"100520577",{"count":19,"type":20},[23],[26,27,28,29],"2026-07-01",{"date":50,"type":34},"2026-07-02",{"date":36,"type":34},{"date":38,"type":20},{"name":40,"class":41},541,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":61,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100641190","phase-1-bre-06-study-to-increase-tolerance-to-aromatase-inhibitors-for-patients-with-early-stage-hormone-receptor-positive-breast-cancer-who-developed-hypoactive-sexual-desire-disorder-100641190","NCT07596212","BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder","Inclusion Criteria:\n\n* Females 18 or older\n* Histologically-proven, resected, hormone receptor-positive (defined as estrogen receptor ≥1% and\u002For progesterone receptor (PgR)≥1% by immunohistochemistry at local institutions) early invasive breast cancer, stage I-III per American Joint Committee of Cancer (AJCC) 8th edition, regardless of Human Epidermal growth factor Receptor 2 (HER2) status\n* Completion of the following planned cancer treatments prior to registration:\n\n  * Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)\n  * Adjuvant radiation therapy, if needed\n  * Neoadjuvant and\u002For adjuvant chemotherapy if needed\n  * Treatment with anti-HER2 agents is allowed\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.\n* Ability to swallow oral medication.\n* Provide written informed consent and fill out questionnaires\n* Willing to return to the enrolling institution for follow-up\n* Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. Women of childbearing potential will be required to use effective contraception from the time of consent until 30 days after the last dose of bupropion. Acceptable methods include hormonal contraception, intrauterine device, barrier methods with spermicide, or sterilization\n\nExclusion Criteria:\n\n* Previous bilateral oophorectomy or ovarian irradiation; pregnant or lactating at the time of randomization or desiring pregnancy within 5 years.\n* History of psychiatric illnesses on active treatment\n* History or active suicidal thoughts or behaviors\n* Currently taking anti-depressants, anti-anxiety, or anti-psychotic medications. History of seizure disorder\n* History of bulimia or anorexia nervosa\n* Inhibitors or inducers of CYP2B6\n* Drugs metabolized by CYP2D6\n* Use of monoamine oxidase inhibitors (MAOI)\n* History of hypertension, regardless of control status.\n* History of angle closure glaucoma\n* Subjects taking levodopa, amantadine, methylene blue, and linezolid\n* Those with a hypersensitivity to bupropion, anastrozole, letrozole, exemestane, goserelin, or leuprolide. Currently receiving any of the following cancer-directed therapies:\n\n  * Radiation therapy\n  * Systemic therapy such as chemotherapy (standard or investigational)\n  * Anti-HER2 agents are allowed","FEMALE",{"count":63,"type":20},100,[65,66],"PHASE1","PHASE2","This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. The researchers want to determine if sexual functioning, as measured by responses on a sexual functioning questionnaire, is improved by adding Bupropion Extended Release (XL) to the AI treatment regimen. Bupropion XL is an FDA-approved medication for the treatment of major depressive disorder, seasonal affective disorder, and nicotine dependence. It has been studied in HSDD in pre- and post-menopausal healthy women, and has been demonstrated to be effective, but it has not been thoroughly studied in women with early-stage breast cancer on AI therapy.",[69,70,71,72],"Early-stage Breast Cancer","Hypoactive Sexual Desire Disorder","Hormone Receptor Positive Breast Carcinoma","Breast Cancer","NOT_YET_RECRUITING","2026-06-16",{"date":76,"type":34},"2026-06-18",{"date":78,"type":20},"2026-07",{"date":80,"type":20},"2031-07",{"name":82,"class":83},"University of Illinois at Chicago","OTHER",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"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":94,"type":20},410,[96],"NA","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.",[99,100,28,29],"Anatomic Stage IV Breast Cancer AJCC v8","Breast Carcinoma",{"date":76,"type":34},{"date":103,"type":34},"2024-01-26",{"date":105,"type":20},"2027-07-31",{"name":107,"class":108},"ECOG-ACRIN Cancer Research Group","NETWORK",506,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":84},"100533350","phase-2-arx788-for-treating-patients-with-her2-low-locally-advanced-unresectable-or-metastatic-breast-cancer-100533350","NCT06224673","ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer","Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate (ADC)) for Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Male or female participants age 18 years or greater with ability to provide written informed consent for the study.\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2.\n* Estimated life expectancy of at least at 6 months per investigator assessment.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Pathologically documented HER2-low locally advanced unresectable or metastatic breast cancer (MBC). NOTE: human epidermal growth factor receptor 2 (HER2)-low status determined by HER2 immunohistochemistry (IHC) 1+ or 2+ and no evidence of HER2 gene amplification by in situ hybridization (ISH)\u002Ffluorescence in situ hybridization (FISH), which can be documented from any tumor sample during the patient's cancer treatment history (early-stage or metastatic).\n\n  * Cohort 1: Participants with hormone receptor positive (HR+)\u002FHER2-low locally advanced unresectable or MBC. HR+ status defined as estrogen receptor \\>= 10% and\u002For progesterone receptor ≥ 10% and HER2 low.\n  * Cohort 2: Participants with hormone receptor negative (HR-)\u002FHER2-low locally advanced unresectable or MBC. Considered HR- if estrogen receptor (ER) and progesterone receptor (PR) \\\u003C 10% and HER2-low.\n* Presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. NOTE: Participant's with at least one measurable lytic bone lesion are eligible.\n* Availability of tumor block or formalin-fixed paraffin-embedded (FFPE) tissue as 10 precut unstained slides will be collected for the HER2 status evaluation and biomarker analysis based on the most recent tumor tissue sample. NOTE: New pretreatment biopsy tissue is preferred as HER2 status may change, but a fresh biopsy is not required. The study team and investigator will make every attempt to get archival tissue. Participants who do not have archival or new tumor tissue available may be eligible after discussion with the study principal investigator (PI).\n* Participants with stable and treated brain metastases are eligible if the participants meet the following criteria:\n\n  * Prior stereotactic radiosurgery (SRS) should be completed \\>=7 days before study treatment initiation.\n  * Prior whole-brain radiation therapy should be completed \\>=14 days before study treatment initiation.\n  * Any ongoing use of systemic corticosteroids does not exceed 2 mg of dexamethasone (or equivalent) daily.\n* Participants must have received at least one prior line of chemotherapy or ADC therapy for locally advanced unresectable or metastatic disease. Prior checkpoint inhibitor therapy is allowed.\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL\n* Platelets ≥ 100,000 x 10\\^9\u002FL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) \\\u003C 3 x institutional upper limit of normal. In participants with liver metastases, \\\u003C= 5 x institutional upper limit of normal is allowed.\n* Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \\\u003C 3 x institutional upper limit of normal. In participants with liver metastases, \\\u003C=5 x institutional upper limit of normal is allowed.\n* Creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m, calculated using the Cockcroft-Gault equation\n* Adequate cardiac function as assessed by left ventricular ejection fraction ≥ 50% or institutional lower limit of normal.\n* Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy.\n* Individuals with a history of hepatitis C virus (HCV) infection must have been treated without detectable HCV RNA.\n* Participants must have recovered from all acute toxicities from prior therapies to ≤ grade 1 or baseline (except for alopecia and neuropathy) per the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.\n* Male and female subjects of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or total sexual abstinence during and upon completion of the study; and for at least 3 months after the last dose of study drug for women of childbearing potential (WOCBP) and at least 5 months after the last dose of study drug for men whose partners are WOCBP.\n* Male subjects must agree to not freeze or donate sperm starting at Screening and throughout the study period, and at least 5 months after the final study drug administration.\n* Female subjects must agree to not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 3 months after the final study drug administration.\n\nExclusion Criteria:\n\n* Has a prior history of treatment with ARX-788 or auristatin analogues.\n* Has a history of allergic reaction to any component of ARX788.\n* Has exposure to any other investigational or commercial anti-cancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of study treatment. NOTE: Anti-hormonal therapy may be administered up to 7 days prior to the first dose of study treatment.\n* Radiotherapy outside of the brain administered \\\u003C7 days prior to first dose of ARX788\n* Prior or current history of interstitial lung disease (ILD), pneumonitis, or other clinically significant lung disease with the exception of disease that is directly attributable to the presence of lung metastases from their underlying cancer.\n* Participants with significant pulmonary conditions, defined as any of the following:\n\n  * Any prior history of drug-induced immune-mediated pneumonitis.\n  * Prior history of radiation therapy to the chest of \\> 18 gray (Gy) with residual sequelae considered clinically significant by investigator assessment.\n  * Radiographic evidence of radiation fibrosis involving \\> 15% of the lung parenchyma associated with clinical symptoms.\n  * Any requirement for supplemental oxygen.\n* Clinically-significant ocular findings including history of keratitis, keratopathy, and\u002For active eye disease (excluding glaucoma).\n* History of congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment. QTcF prolongation of \\>470 msec (females) or \\>450 msec (males) based screening ECG.\n* Has a diagnosis of leptomeningeal carcinomatosis. NOTE: Stable brain metastases are allowed.\n* Has an active systemic or psychiatric illness that would impact the patient's ability to receive study therapy.\n* Has an uncontrollable intercurrent illness, infection (including participants with active, symptomatic Coronavirus disease of 2019 (COVID-19) infections), or other conditions that could limit study compliance or interfere with study assessments.\n* Has a history of an additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ (excluding carcinoma in situ of the bladder or high-grade cervical dysplasia in the last three years), and thyroid cancer not requiring cytotoxic agents that have undergone potentially curative therapy are not excluded.\n* Pregnancy or breastfeeding.\n* Has an active, uncontrolled hepatitis B, hepatitis C, and\u002For human immunodeficiency virus (HIV) infection. Participants with adequately controlled hepatitis B, hepatitis C, and\u002For HIV are allowed. NOTE: HIV and hepatitis B and C testing are not required for screening. Testing will only be done if clinically indicated.",{"count":118,"type":20},36,[66],"This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer. ARX788 is an antibody-drug conjugate (ADC) that is given by infusion (diluted and injected slowly into veins). Antibodies are proteins which are naturally produced by the body's immune system to help fight infections. ARX788 consists of antibodies that have been attached to a toxin that has the potential to kill cancer cells. ARX788 sticks to a protein called human epidermal growth factor receptor (HER2), which is found on some breast cancer cells. Giving ARX788 may be safe and effective in treating patients with HER2-low locally advanced unresectable metastatic breast cancer.",[122,123,124,71],"HER2 Low Breast Carcinoma","Triple Negative Breast Cancer","Hormone-receptor-positive Breast Cancer",[126],"Antibody-drug Conjugate","2026-06-08",{"date":129,"type":34},"2026-06-11",{"date":131,"type":34},"2026-06-05",{"date":133,"type":20},"2029-11-30",{"name":135,"class":83},"Laura Huppert, MD, BA",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100553499","phase-2-safety-and-efficacy-of-t-dxd-vs-cdk46i-based-et-as-first-line-therapy-of-hr-positive-and-her2-lowultralow-advanced-breast-cancer-patients-classified-as-non-luminal-subtype-100553499","NCT06486883","Safety and Efficacy of T-DXd vs. CDK4\u002F6i-based ET as First-line Therapy of HR-positive and HER2-low\u002FUltralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype","A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4\u002F6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low\u002FUltralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.","PONTIAC","Inclusion Criteria:\n\n1. Patients must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male patients ≥ 18 years of age at the time of signing ICF.\n3. ECOG performance status of 0-1.\n4. Minimum life expectancy of ≥ 12 weeks at screening.\n5. Evidence of HER2-low expression (1+ by immunohistochemistry (IHC) or 2+ and negative by an in situ hybridization \\[ISH\\] test) or HER2-ultralow (IHC 0 with faint membrane staining and in ≤ 10% of tumor cells) breast cancer according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines determined by a MEDSIR's designated central laboratory, using Ventana 4B5 antibody. This assessment has to be done on the most recently available (archived or newly collected) formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion, excluding bone metastases.\n6. Non-luminal breast cancer subtype as per central PAM50 analysis determined in the most recently available (archived or newly collected) FFPE tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion with the exception of bone metastases.\n7. Patients must have HR-positive (estrogen receptor \\[ER\\] and\u002For progesterone receptor \\[PgR\\]-positive defined as ≥ 1% positive stained cells) status according to the most recent ASCO\u002FCAP guidelines locally determined prior to study entry.\n8. Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n9. Evaluable disease according to RECIST v.1.1. Patients with bone-only disease are not allowed. Patients with bone metastases with soft tissue masses measuring \\> 10 mm are eligible.\n10. Patients must have endocrine resistance criteria:\n\n    • disease progression during adjuvant ET or within the first year of completing adjuvant ET;\n\n    or endocrine sensitivity criteria:\n\n    • de novo metastatic disease or disease progression ≥ 12 months after completing adjuvant ET with at least one of the following requirements:\n    * Estrogen receptor ≤ 50% positive stained cells;\n    * and\u002For high histological grade or Ki67 \\> 50% on primary tumor;\n    * and\u002For liver metastases;\n    * and\u002For known non-luminal subtype as per local PAM50 analysis.\n11. No prior treatment with any systemic therapy for advanced disease.\n12. Patients treated with a CDK4\u002F6i in the adjuvant setting with a treatment-free interval (TFI) ≥ 12 months following CDK4\u002F6i treatment completion are eligible.\n13. Patients have adequate bone marrow, liver, and renal function:\n\n    * Hematological (without platelet, red blood cell transfusion, and\u002For granulocyte colony-stimulating factor support within 14 days before first study treatment dose): White blood cell (WBC) count \\> 3.0 x 109\u002FL, absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL, platelet count ≥ 100.0 x 109\u002FL, and hemoglobin ≥ 9.0 g\u002FdL (≥ 5.6mmol\u002FL).\n    * Hepatic: Serum albumin ≥ 2.5 g\u002FdL; total bilirubin ≤ 1.5 times upper limit of normal (x ULN) (≤ 3 x ULN in patients with liver metastases or know history of Gilbert's disease); alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver\u002For bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN (≤ 5 x ULN in patients with liver metastases).\n    * Renal: Creatinine clearance ≥ 30 mL\u002Fmin as determined by Cockcroft Gault (using actual body weight).\n    * Coagulation: International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN.\n14. Resolution of all acute toxic effects of prior anti-cancer therapy to Grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\n15. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4\u002F6i plus ET. Female patients must refrain from egg cell donation and breastfeeding during this same period.\n16. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4\u002F6i plus ET. Male participants must not donate or bank sperm during this same period.\n17. Patients must be accessible for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Current participation in another therapeutic clinical trial, except other translational studies.\n2. Treatment with approved or investigational cancer therapy within 3 weeks prior to initiation of study drug.\n3. Treatment with chloroquine\u002Fhydroxychloroquine within 14 days prior to initiation of study drug.\n4. Have previously been treated with T-DXd and\u002For fulvestrant. Note: patients who experienced relapse after more than 1 year from completion of fulvestrant are eligible.\n\n   Note I: previous treatment with anti-HER2 therapies in (neo-) adjuvant setting will be allowed for participants who showed conversion from HER2-positive expression in primary breast tumor sample to HER2-low or HER2-ultralow expression (HER2 loss) in relapsed tumor sample.\n5. Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \\[pleural, pericardial, and\u002For peritoneal\\] and pulmonary lymphangitis).\n6. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of CDK4\u002F6i, such as history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease, or diarrhea of CTCAE Grade \\> 1.\n7. Known central nervous system (CNS) involvement (brain metastases and\u002For leptomeningeal carcinomatosis). Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n8. Have a concurrent malignancy or malignancy within 5 years of study enrollment with the exception of carcinoma in situ of the cervix and basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.\n9. Known allergy or hypersensitivity reaction to any of the investigational medicinal products (IMPs) or their inactive ingredients.\n10. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks prior to start of study treatment.\n11. Major surgical procedure or significant traumatic injury within 4 weeks before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment.\n12. Has an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following:\n\n    * Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (NYHA Class II to IV), unstable angina pectoris, or a recent (\\\u003C 6 months) cardiovascular event including stroke. Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation to rule out myocardial infarction.\n    * Left ventricular ejection fraction (LVEF) \\\u003C 55% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO).\n    * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia), which is symptomatic or requires treatment (NCI-CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers will be permitted to enroll.\n    * QT interval corrected by Fridericia's formula (QTcF) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG).\n    * History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.\n    * Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.\n13. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy (complete).\n14. Has a history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n15. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.\n16. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test), and \\> 6 months off anti-viral treatment are eligible. Those participants should be closely monitored for HBV reactivation and have access to a local hepatitis B expert during and after the study.\n17. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n18. Patients with HCV co-infection or history of HCV co-infection.\n19. Patients with cirrhosis or fibrosis on prior imaging or biopsy.\n20. Has an active primary immunodeficiency or known human immunodeficiency virus (HIV) infection.\n21. Other active uncontrolled infection at the time of enrollment.\n22. Receipt of live or attenuated vaccine within 30 days prior to the first dose of study treatment.\n23. A history of uncontrolled seizures, CNS disorders, or serious and\u002For unstable pre-existing psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs or interfering with subject safety.\n24. Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Medications Section).\n25. Known substance abuse or any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.\n26. Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.",{"count":145,"type":20},200,[66],"This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive\u002FHER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4\u002F6 inhibitor (CDK4\u002F6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low\u002Fultralow advanced breast cancer classified as non-luminal subtype.",[149,150,71],"Advanced Breast Cancer","Advanced Breast Carcinoma","2026-06-01",{"date":153,"type":34},"2026-06-02",{"date":155,"type":34},"2025-06-30",{"date":157,"type":20},"2028-01",{"name":159,"class":83},"MedSIR",72,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":191},"100627900","phase-1-ava6103-in-subjects-with-locally-advanced-or-metastatic-selected-solid-tumors-100627900","NCT07454642","AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","FOCUS-01","Inclusion Criteria:\n\n1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).\n2. Male or female subjects, ≥18 years of age.\n3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments\n\n   1. Cervical\u002Fvulvar cancer\n   2. SCLC\n   3. Gastric\u002FGEJ cancer\n   4. PDAC\n   5. CRC\n   6. HR+ breast cancer\n4. Has a life expectancy of ≥3 months, in the opinion of the investigator.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).\n7. Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):\n\n   1. Absolute neutrophil count of ≥1.5 × 109 cells\u002FL. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells\u002FL\n   2. Hemoglobin ≥9.0 g\u002FdL.\n   3. Platelet count of ≥100,000\u002FµL.\n   4. International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation.\n8. Has adequate liver function:\n\n   1. Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \\\u003C3 × ULN).\n   2. AST and ALT ≤2.5 × ULN (in subjects with liver metastases, \\\u003C5 × ULN is allowed).\n9. Has adequate renal function as defined by creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation.\n10. Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.\n11. Contraception requirements:\n\n    1. Female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C 1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    2. Male subjects with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    3. Male subjects must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n12. The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.\n\n    1. For subjects in Phase 1a or 1b, on treatment tumor biopsy is optional. -\n\nExclusion Criteria:\n\n1. Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg\u002Fday or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.\n2. Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.\n3. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n4. History or evidence of any other clinically unstable\u002Funcontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.\n5. History of known infection is defined as:\n\n   1. HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\>400 copies\u002FmL prior to study Day 1.\n   2. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n   3. Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Subjects with active disease who are not on\u002Fhave not initiated anti-retroviral treatment prior to study Day 1.\n   5. Subjects with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Subjects with treated HCV infection but with an HCV viral load above the level of quantification.\n   7. Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n6. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.\n7. Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.\n8. Is a pregnant or breastfeeding woman.\n9. Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.\n10. Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.\n11. Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:\n\n    1. Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.\n    2. Subjects who have received a monoclonal antibody.\n12. Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.\n13. Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.\n14. Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and\u002For where these drugs will be in the systemic circulation at the start of Cycle 1, Day 1. For this protocol, it means that the drug must not be used within 5 half-lives (or 5 days, whichever is longer) prior to AVA6103 Cycle 1 Day 1 and during study treatment.\n15. Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.\n16. Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.\n17. Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done \\>96 hours prior to AVA6103 administration. For the dose escalation phase, it should be administered after completion of the DLT period.\n18. QT interval corrected through use of Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.",{"count":170,"type":20},174,[65],"This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[174,175,176,177,178,179,180,181,71],"Vulvar Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Small Cell Carcinoma of Lung","Colorectal Cancer","2026-05-29",{"date":153,"type":34},{"date":185,"type":34},"2026-03-31",{"date":187,"type":20},"2030-06",{"name":189,"class":190},"Avacta Life Sciences Ltd","INDUSTRY",3,{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":61,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":199,"phases":4,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":84},"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":63,"type":20},"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.",[202,124,203,26,27,99,204,71,205],"HER2-negative Breast Cancer","Metastatic Breast Cancer","HER2 Negative Breast Carcinoma","Metastatic Breast Carcinoma","2026-05-28",{"date":151,"type":34},{"date":209,"type":34},"2024-04-30",{"date":211,"type":20},"2031-06-15",{"name":213,"class":83},"Mayo Clinic",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":230,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":222,"type":20},399,[65],"This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[226,149,203,124,71,227,202,228,229],"Advanced Solid Tumor","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[231,232,233,234,235,228,236,237],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer","2026-05-26",{"date":240,"type":34},"2026-05-27",{"date":242,"type":34},"2023-12-01",{"date":244,"type":20},"2028-11",{"name":246,"class":190},"BeOne Medicines",63,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":255,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100385985","phase-2-abemaciclib-and-endocrine-therapy-in-older-patients-with-breast-cancer-100385985","NCT04305834","Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.","A Phase IIA Trial Assessing the Tolerability of Abemaciclib in Combination With Endocrine Therapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer Who Have Progressed on or After Prior CDK 4\u002F6 Inhibition","Inclusion Criteria:\n\n* Documented informed consent of the participant\n* Age \\>= 70 years\n* Life expectancy \\> 6 months\n* Ability to read and understand English or Spanish\n* Measurable or non-measurable disease\n* Histologically or cytologically confirmed diagnosis of:\n\n  * Estrogen-receptor positive and\u002For progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods according to the local institution standard protocol\n  * HER2-negative breast cancer defined as negative if the IHC status is 0 or 1+, or if IHC is 2+ and in situ hybridization assay is negative per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines\n* Radiographically confirmed metastatic breast cancer\n* Progressed on prior endocrine therapy or palbociclib or ribociclib or chemotherapy\n* Patients who received chemotherapy recovered from the acute side effects to prior cancer therapy (except alopecia or residual grade 2 peripheral neuropathy) to =\\\u003C grade 1 or baseline. A washout period of at least 21 days is required between last chemotherapy dose and randomization (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 randomization\n* Absence of central nervous system (CNS) involvement unless they meet ONE of the following criteria:\n\n  * Untreated brain metastases (e.g., lesions \\\u003C 1 cm) not needing immediate local therapy\n  * Previously treated brain metastases not needing immediate local therapy\n\n    * At least 4 weeks from the last date of prior therapy completion (including radiation and\u002For surgery) to starting the study treatment\n    * Clinically stable CNS tumor at the time of screening and not receiving steroids and\u002For enzyme-inducing anti-epileptic medications for brain metastases\n* Absence of interstitial lung disease\u002Fpneumonitis\n* Absolute neutrophil count (ANC) \\>= 1.5 X 10\\^9\u002FL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Hemoglobin \\>= 8 g\u002FdL\n\n  * (Patients 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* In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3.0 x upper limit of normal (ULN)\n\n  * If the patient has liver metastases, ALT and AST \\\u003C 5 x ULN\n* In patients without Gilbert's syndrome, total bilirubin =\\\u003C 1.5 x ULN; In patients with Gilbert's syndrome, total bilirubin =\\\u003C 2.0 x ULN or direct bilirubin within normal limits (WLN)\n* Creatinine clearance of \\>= 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n* Major surgery within 14 days prior to receiving study drug or has not recovered from major side effect\n* Patient is currently receiving any of the prohibited medications detailed below and cannot be discontinued 7 days prior to starting study drug\n\n  * Other investigational therapy should be given to participants\n  * Anticancer agents other than the study medications administered as part of this study protocol should be given to participants. If such agents are required for a participant then the participant must first be withdrawn from the study\n  * Co-medication that may interfere with study results; e.g. immune-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrolimus are prohibited during the treatment phase of the study, unless discussed with principal investigator felt to be of low clinical risk to the participant\n  * Use of herbal medications may have unknown interactions with the metabolism of the study agents, and therefore are prohibited from use during the treatment phase of the trial\n* Known hypersensitivity to any of the excipients of abemaciclib\n* 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* Impairment of gastrointestinal (GI) function or GI disease that in the investigator's opinion may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n* 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* Patient has any other concurrent severe or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis)\n* Inability to swallow oral medications\n* Serious or 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 \\\u003C 30 ml\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* History of non-compliance to medical regimen\n* Patients with a prior malignancy diagnosed within 2 years and with evidence of disease (except adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer","70 Years",{"count":257,"type":20},43,[66],"This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.",[99,71,205,261],"Prognostic Stage IV Breast Cancer AJCC v8","2026-04-30",{"date":264,"type":34},"2026-05-04",{"date":266,"type":34},"2020-03-25",{"date":268,"type":20},"2026-08-21",{"name":270,"class":83},"City of Hope Medical Center",6,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":61,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":283,"conditions":284,"keywords":292,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100596217","phase-4-a-study-of-revaree-plus-in-people-with-breast-cancer-100596217","NCT07042581","A Study of Revaree Plus in People With Breast Cancer","Evaluation of Revaree Plus in Women With Breast Cancer","Inclusion Criteria:\n\n* ≥18 years of age at the time of signing informed consent.\n* Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC\n* Able to complete study questionnaires in English or Spanish\n* Breast cancer patients must have completed primary therapy (surgery, and\u002For chemotherapy, and\u002For radiation therapy) or currently on maintenance therapy\n* Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM)\n* Currently have no clinical evidence of disease\n* Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \\[pain with intercourse or examination\\])\n* A total score of 4 or greater in VAS\n* Without history of other cancers (excluding non-melanoma skin cancer)\n* Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Vaginal bleeding of unknown etiology within 12 months of study entry\n* Currently taking hormone replacement therapy \\[local or systemic\\] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)\n* Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)\n* No known allergies to any ingredients in 10mg HLA suppository",{"count":280,"type":20},60,[282],"PHASE4","The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.",[72,285,286,287,288,289,290,291,124,71,227],"Stage 0 Breast Cancer","Stage I Breast Cancer","Stage II Breast Cancer","Stage III Breast Cancer","Stage 0 Breast Carcinoma","Stage II Breast Carcinoma","Stage III Breast Carcinoma",[72,285,286,287,288,293,294,295,296,297,298,299],"Stage 0 hormone receptor positive breast cancer","Stage I hormone receptor positive breast cancer","Stage II hormone receptor positive breast cancer","Stage III hormone receptor positive breast cancer","Revaree","24-374","Memorial Sloan Kettering Cancer Center","2026-02-04",{"date":302,"type":34},"2026-02-06",{"date":304,"type":34},"2025-06-20",{"date":306,"type":20},"2029-06-20",{"name":299,"class":83},7,{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":61,"minAge":17,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"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":317,"type":20},150,[96],"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.",[321,26,27,28,29],"Anatomic Stage I Breast Cancer AJCC v8",[323,324,325],"Disparities","Health Equity","Health Services","2026-01-27",{"date":328,"type":34},"2026-01-29",{"date":330,"type":34},"2024-12-12",{"date":332,"type":20},"2027-12-31",{"name":334,"class":83},"Emory University",4,{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":199,"phases":4,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":84},"100619198","the-sleep-after-breast-cancer-abc-study---examining-sleep-changes-and-biomarkers-among-breast-cancer-patients-100619198","NCT07341503","The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients","Inclusion Criteria:\n\n* \\* Age \\>= 18 years old at time of breast cancer diagnosis\n\n  * Stage I to III breast cancer diagnosis\n  * Hormone receptor positive breast cancers\n  * Post primary surgery, before chemotherapy\u002Fradiation therapy begins\n  * No known evidence of breast cancer recurrence (local or distant) or second, primary cancer\n  * No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer)\n  * Able to speak, understand and read English\n  * Cognitively able to complete the study requirements\n  * Ability to access medical records from treating hospital\n\nExclusion Criteria:\n\n* \\* Stage IV or metastatic breast cancer\n\n  * Not cognitively able to provide informed consent\n  * Not willing to provide informed consent",{"count":63,"type":20},"This study is being done to learn more about breast cancer patients' experiences with sleep changes during cancer treatment, identify possible reasons for poor sleep quality, and to find out how stress, social support, and living environment affect sleep.",[321,26,27,100,29],"2026-01-06",{"date":347,"type":34},"2026-01-14",{"date":349,"type":34},"2025-08-18",{"date":351,"type":20},"2026-12-31",{"name":353,"class":83},"Ohio State University Comprehensive Cancer Center",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":377},"100405007","phase-2-trastuzumab-deruxtecan-alone-or-in-combination-with-anastrozole-for-the-treatment-of-early-stage-her2-low-hormone-receptor-positive-breast-cancer-100405007","NCT04553770","Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer","A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting","Inclusion Criteria:\n\n* Previously untreated operable invasive carcinoma of the breast greater than 2.0 cm (cT2) in size based on physical exam or imaging. Patients with clinical node negative disease or clinical node (cN1\u002FcN2) positive are allowed provided they are deemed to have operable disease at study entry\n* Participants with clinically involved lymph nodes should not have radiological evidence of distant disease per standard of care staging prior to patient informed consent form (PICF) signature\n* In the United States\n* Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+, confirmed by central testing (central testing results not required for enrollment, unless no local results available). If HER2 is 2+ by IHC, fluorescence in situ hybridization (FISH) must be performed (per standard of care) and the FISH result must be HER2 non-amplified per 2018 American Society of Clinical Oncology College of American Pathologists (ASCO CAP) guidelines\n* Tumor is HR positive (HR+) per ASCO CAP guidelines with known estrogen and progesterone receptor status, locally defined\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Normal cardiac function (left ventricular ejection fraction \\[LVEF\\] \\>= 50%) based on echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization\u002Fenrollment\n* Platelet count \\>= 100 000\u002Fmm\\^3 (Platelet transfusion is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Hemoglobin \\>= 9.0 g\u002FdL (red blood cell transfusion is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Absolute neutrophil count (ANC) \\>=1500\u002Fmm\\^3 (Granulocyte colony-stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Creatinine clearance \\>= 30 mL\u002Fmin as calculated using the Cockcroft-Gault equation or serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) (within 14 days before randomization\u002Fenrollment)\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 3 x ULN (within 14 days before randomization\u002Fenrollment)\n* Total bilirubin =\\\u003C 1.5 x ULN (within 14 days of randomization\u002Fenrollment). Participants with Gilbert's syndrome with a total bilirubin =\\\u003C 2.0 times ULN and direct bilirubin within normal limits are permitted\n* Serum albumin \\>= 2.5 g\u002FdL (within 14 days before randomization\u002Fenrollment)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (within 14 days before randomization\u002Fenrollment)\n* Has adequate treatment washout period before randomization\u002Fenrollment, defined as:\n\n  * Major surgery \\>= 4 weeks\n  * Chloroquine\u002Fhydroxychloroquine \\> 14 days\n* Negative pregnancy test (serum) for women of child bearing potential (CBP):\n\n  * Women are considered of CBP unless: they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment she is considered not of CBP\n* Male and female participants of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Highly effective contraception methods include:\n\n  * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n  * Male partner sterilization (at least 6 months prior to randomization). For female patients on the trial the vasectomized male partner should be the sole partner for that patient. If vasectomy of the male partner is the highly effective method of contraception chosen, the success of the vasectomy should be medically confirmed according to local practice\n  * Placement of an intrauterine device (IUD)\n* Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study\n* Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Estradiol level must be in post-menopausal range per local lab interpretation prior to baseline biopsy\n\n  * Postmenopausal status is defined as:\n\n    * Patient underwent bilateral oophorectomy, or\n    * Age \\>= 60 years, or\n    * Age \\\u003C 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges\n  * Note: for women with therapy-induced amenorrhea, serial measurements of FSH and\u002For estradiol per local clinical guidelines are required for determination of postmenopausal status. All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial\n* Pre- or peri-menopausal and amenable to being treated with ovarian function suppression drugs (goserelin, leuprolide, or triptorelin) per standard of care. Patients must have started treatment with ovarian function suppression at least 28 days prior to first dose of study treatment\n\nExclusion Criteria:\n\n* Recurrent or metastatic breast cancer\n* Bilateral breast cancer (multifocal or multicentric breast cancer is allowed provided that all biopsied lesions are HER2 1+ or 2+, not FISH amplified and are HR positive per ASCO guidelines)\n* Inflammatory breast cancer\n* Prior systemic therapy for invasive cancer\n\n  * Prior tamoxifen for history of ductal breast carcinoma in situ (DCIS) allowed, but no prior aromatase inhibitor, no prior chemotherapy and no prior HER2-targeted therapy\n* Prior ipsilateral chest wall radiation\n* Major surgery \\\u003C 4 weeks prior to enrollment\n* Medical history of myocardial infarction within 6 months before randomization\u002Fenrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to randomization\n* Unable to swallow oral medications\n* Is pregnant or lactating, or planning to become pregnant\n* Corrected QT interval prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram\n* Known hypercoaguable disorder requiring use of anticoagulant\n* Significant gastrointestinal disorders limiting absorption or tolerance of oral medications (for example, 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* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Has multiple primary malignancies within 3 years, except:\n\n  * Adequately resected non-melanoma skin cancer\n  * Curatively treated non breast in-situ disease, and other solid non-breast tumors curatively treated are allowed if \\> 3 years from diagnosis and no evidence of recurrence in that time\n  * Prior history of DCIS is allowed as long as patient has not received an aromatase inhibitor, has not received ipsilateral breast\u002Fchest radiation\n  * Prior history of contralateral invasive breast cancer (diagnosed by biopsy \\> 2 years prior to current diagnosis) is allowed provided patient has not received prior aromatase inhibitor, CDK4\u002F6 inhibitor (CDK4\u002F6i), HER2-targeted therapy or chemotherapy and has not experienced any recurrence and has no evidence of recurrence (based on standard clinical evaluation)\n* Other concurrent anti-cancer therapy. Note: ovarian function suppression drugs (goserelin, leuprolide, or triptorelin) and\u002For bone modifying agents (bisphosphonates, denosumab) do not count as anti-cancer therapy for this criteria. If taking bisphosphonates or denosumab, must have been on these agents prior to signing consent\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results\n* Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Subjects should be tested for HIV prior to randomization\u002Fenrollment if required by local regulations or Institutional Review Board (IRB)\u002Fethics committee (EC)\n* Have personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest\n* Have received an autologous or allogeneic stem-cell transplant\n* 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* Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to first baseline biopsy\n* Has history of severe hypersensitivity reactions to other monoclonal antibodies and\u002For to either the drug substances or inactive ingredients in the drug product\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (i.e. rheumatoid arthritis, Sjogren's, sarcoidosis etc.), or prior pneumonectomy\n* Life expectancy \\\u003C 3 months",{"count":362,"type":20},88,[66],"This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.",[69,71,366,287,367,368,288],"Invasive Breast Cancer","Stage IIA Breast Cancer","Stage IIB Breast Cancer","2025-11-06",{"date":371,"type":34},"2025-11-10",{"date":373,"type":34},"2020-10-09",{"date":351,"type":20},{"name":376,"class":83},"Jonsson Comprehensive Cancer Center",9,{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":21,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":84},"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":386,"type":20},55,[96],"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.",[321,26,27,390,204,71,391],"Breast Ductal Carcinoma in Situ","Invasive Breast Carcinoma","2025-07-30",{"date":394,"type":34},"2025-08-01",{"date":396,"type":34},"2022-07-28",{"date":398,"type":20},"2027-05-01",{"name":400,"class":83},"Thomas Jefferson University",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":61,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":420,"locationsCount":84},"100596350","phase-2-5-strain-probiotic-formulation-in-hr-positive-breast-cancer-receiving-aromatase-inhibitor-to-prevent-bone-loss-100596350","NCT07044310","5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss","Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss","Inclusion Criteria:\n\n* Female age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\n* Histologically confirmed anatomical stage 0-III hormone receptor-positive breast cancer\n* Will be starting on an aromatase inhibitor (letrozole, anastrozole, or exemestane) ± ovarian function suppression (OFS) per treating physician's discretion\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 (prior to registration)\n* Platelet count ≥ 75,000\u002Fmm\\^3 (prior to registration)\n* Hemoglobin ≥ 9.0 g\u002FdL (prior to registration)\n* Creatinine ≤ 2 x upper limit of normal (ULN) (prior to registration)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) ≤ 2 x ULN (prior to registration)\n* Albumin ≥ 3 g\u002FdL (prior to registration)\n* Willing and able to provide research stool and blood samples\n* Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only (\\\u003C 60 years old with intact uterus)\n* Capable of providing valid informed consent\n* Willing to return to enrolling institution for all study visits (blood draws, etc)\n\nExclusion Criteria:\n\n* Requires prolonged systemic antibiotic therapy for other conditions and recent systemic antibiotic ≤ 14 days prior to registration\n* Fecal microbiota transplant (FMT) ≤ 6 months prior to registration\n* FMT with an associated serious adverse event related to the FMT product or procedure\n* Co-morbid systemic illnesses or other severe concurrent diseases 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 over-the-counter probiotics\n* Immunocompromised patients including patients known to be HIV positive or those on chronic steroids \\> 20 mg prednisone a day or prednisone-equivalent. Note: Must be off systemic steroids ≥ 90 days prior to registration. However, topical steroids, inhalants, or steroid eye drops are permitted\n* History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis\n* History of chronic diarrhea\n* History of celiac disease\n* Currently has a colostomy\n* Intraabdominal surgery related to gastrointestinal tract ≤ 60 days prior to registration\n* Evidence of active, severe colitis\n* History of short gut syndrome or motility disorders\n* Requires the daily use of medications to manage bowel hypermotility, such as imodium or lomotil\n* Active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive products) prior to registration. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment ≤ 30 days prior to registration are not excluded\n* History of osteoporosis or hyperparathyroidism\n* History of untreated vitamin D deficiency\n* Receiving or will receive bisphosphonates during study period (alendronate, risedronate, ibandronate, pamidronate, or zolendronic acid) or denosumab\n* Patients who received oral bisphosphonate within ≤ 12 weeks, intravenous (IV) zoledronic acid (Reclast) ≤ 52 weeks, or denosumab ≤ 24 weeks will also be excluded\n* Known hypersensitivity to any component of study product (including known inulin intolerance)\n* Known hypersensitivity to \\> 4 first-line antimicrobial therapies against akkermansia muciniphila, clostridium beijerinckii, clostridium butyricum, anaerobutyricum hallii, including penicillin, piperacillin, tetracycline, amoxicillin, or ampicillin\n* Known hypersensitivity to \\> 4 first line antimicrobial therapies against bifidobacterium infantis Bi-26TM, including gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin\n* Received an experimental product ≤ 30 days prior to registration\n* Receiving or will receive CDK 4\u002F6 inhibitor (abemaciclib, ribociclib, or palbociclib)\n* Received chemotherapy ≤ 30 days prior to registration",{"count":409,"type":20},38,[66],"This phase II trial tests how well a probiotic, WBF-038, works in preventing bone loss in patients with early-stage hormone receptor-positive breast cancer who are starting treatment with aromatase inhibitors. Aromatase inhibitors are a drug that blocks the activity of an enzyme called aromatase, which the body uses to make estrogen in the ovaries and other tissues. Blocking aromatase lowers the amount of estrogen made by the body, which may stop the growth of cancer cells that need estrogen to grow. Aromatase inhibitors are used to treat some types of breast cancer or to keep it from coming back. Aromatase inhibitors can affect bone health, weight, blood sugar, and waist size. WBF-038 is a combination of both prebiotics and probiotics, designed to improve metabolic health. Giving WBF-038 may improve bone turnover, bone health, blood sugar, weight, and waist circumference in patients with early-stage hormone receptor-positive breast cancer starting on adjuvant endocrine therapy with an aromatase inhibitor.",[413,321,26,27,29],"Anatomic Stage 0 Breast Cancer AJCC v8","2025-07-25",{"date":416,"type":34},"2025-07-29",{"date":414,"type":34},{"date":419,"type":20},"2027-07-25",{"name":213,"class":83},{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":61,"minAge":17,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":21,"phases":430,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":335},"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":429,"type":20},40,[431],"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.",[321,26,27,28,29,391],"2025-05-20",{"date":436,"type":34},"2025-05-23",{"date":438,"type":34},"2022-09-02",{"date":440,"type":20},"2027-04-15",{"name":334,"class":83},{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":199,"phases":4,"briefSummary":452,"conditions":453,"keywords":490,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":504},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":451,"type":20},3500,"PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[454,455,456,100,457,458,459,72,460,461,462,463,464,465,466,467,468,469,470,471,472,71,473,228,227,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489],"Breast Adenocarcinoma","Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Diseases","Breast Neoplasms","Breast Neoplasms, Male","Breast Cancer With Metastatic Bone Disease","Breast Cancers","Breast Neoplasm","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HR+\u002FHER2- Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor-Positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","Ribociclib","Abemaciclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[491,492,485,486,487,493,494,203],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","2025-01-28",{"date":497,"type":34},"2025-02-03",{"date":499,"type":34},"2023-05-01",{"date":501,"type":20},"2040-12-31",{"name":503,"class":83},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",24]