[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"interventionName\":\"Hormone Therapy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,70,93],{"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},"100624306","phase-2-ph2-study-for-optimization-of-adjunct-systemic-therapy-in-her2-patients-molecularpcr-trial-100624306",false,"NCT07407920","Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial","Optimization of Adjuvant Systemic Therapy in Patients With Early HER2-Positive (HER2+) Breast Cancer or Triple Negative Breast Cancer (TNBC) That Achieved a Pathological Complete Response (pCR) After Neoadjuvant Systemic Therapy and Do Not Have Molecular Residual Disease (MRD-Negative): A Phase II Clinical Trial (The MolecularPCR Trial)","Inclusion Criteria:\n\n* EARLY HER2 POSITIVE (+) BREAST CANCER COHORT: Female or male with a diagnosis of biopsy proven invasive breast cancer HER2+, hormone (estrogen and progesterone)-receptor positive or negative. The HER2 status (following American Society of Clinical Oncology \\[ASCO\\]\u002FCollege of American Pathologists \\[CAP\\] guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines\n* EARLY TNBC COHORT: Female or male with a diagnosis of biopsy proven invasive TNBC (estrogen and progesterone receptor \\\u003C 10%). The HER2 status (following ASCO\u002FCAP guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines\n* FOR BOTH HER2+ AND TNBC COHORTS: Invasive breast cancer of any tumor histologic grade and\u002For nuclear grade, and any tumor histological subtype including but not limited to infiltrating ductal carcinoma, infiltrating lobular carcinoma, mucinous carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, and mixed histology\n* FOR BOTH HER2+ AND TNBC COHORTS: Clinical tumor stage (per American Joint Committee on Cancer \\[AJCC\\] 8th edition): T1-4, N0-2a, M0. Patients who have a diagnosis of inflammatory breast cancer are eligible. Patients should not have clinical evidence of locoregional or distant metastatic breast cancer\n* EARLY HER2+ BREAST CANCER COHORT: Have completed NST with a trastuzumab plus pertuzumab and chemotherapy-based regimen (for example, docetaxel plus minus carboplatin plus trastuzumab plus pertuzumab known as the docetaxel\u002Fpertuzumab\u002Ftrastuzumab \\[THP\\]\u002Fcarboplatin\u002Fpaclitaxel\u002Fpertuzumab\u002Ftrastuzumab \\[TCHP\\] regimens) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant trastuzumab plus pertuzumab\n* EARLY TNBC COHORT: Have completed NST with a pembrolizumab plus chemotherapy-based regimen (for example, the KEYNOTE-522 regimen which is paclitaxel plus carboplatin plus pembrolizumab followed by doxorubicin plus cyclophosphamide plus pembrolizumab) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant pembrolizumab\n* The surgical pathology report needs to show a pCR (ypT0-Tis, ypN0) for a patient to be able to participate in this study and all enrolled patients should be willing to discontinue standard adjuvant systemic therapy\n* FOR BOTH HER2+ AND TNBC COHORTS: Adequate archival tumor tissue from the core diagnostic biopsy (per Personalis)\n* FOR BOTH HER2+ AND TNBC COHORTS: Age ≥ 18 years\n* FOR BOTH HER2+ AND TNBC COHORTS: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* FOR BOTH HER2+ AND TNBC COHORTS: Absolute neutrophil count ≥ 1,000\u002FmcL\n* FOR BOTH HER2+ AND TNBC COHORTS: Hemoglobin ≥ 9.0 g\u002FdL\n* FOR BOTH HER2+ AND TNBC COHORTS: Platelets ≥ 100,000\u002FmcL\n* FOR BOTH HER2+ AND TNBC COHORTS: Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN); patients with Gilbert's syndrome (if direct bilirubin \\\u003C1.5 x institutional ULN)\n* FOR BOTH HER2+ AND TNBC COHORTS: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* FOR BOTH HER2+ AND TNBC COHORTS: Creatinine ≤ 1.5 mg\u002FdL\n* FOR BOTH HER2+ AND TNBC COHORTS: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* FOR BOTH HER2+ AND TNBC COHORTS: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* FOR BOTH HER2+ AND TNBC COHORTS: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible\n* FOR BOTH HER2+ AND TNBC COHORTS: Pre- and postmenopausal women are eligible\n* FOR BOTH HER2+ AND TNBC COHORTS: Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients with tumor stage of cN2b or cN3 are not eligible\n* History of other malignancies besides breast cancer within the past 5 years, except cervical cancer in situ, melanoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin\n* Patients who are receiving any other anti-cancer investigational agents\n* Patients with known cancer metastases from any site\n* Patients with uncontrolled intercurrent illness including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrythmias\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Blood transfusion within 2 weeks before collection of blood for ctDNA testing\n* Patients who have received 4 or more cycles of SOC adjuvant trastuzumab\u002Fpertuzumab (HER2+) or 4 or more cycles of SOC adjuvant pembrolizumab (TNBC)\n* Pregnant women are not eligible to participate in this study","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease) circulating in their blood. Standard of care treatment after surgery consists of 1 year of pembrolizumab for patients with triple negative breast cancer or trastuzumab with or without pertuzumab to complete 1 year of treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Lowering the total amount of cancer therapy after breast surgery, may continue to keep the great tumor response to treatment, and may help lower the amount of side effects patients have.",[26,27,28,29],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Early Stage HER2-Positive Breast Carcinoma","Early Stage Triple-Negative Breast Carcinoma","RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-24","ACTUAL",{"date":36,"type":34},"2025-10-09",{"date":38,"type":20},"2027-09-30",{"name":40,"class":41},"M.D. Anderson Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100637663","phase-3-adding-surgery-and-radiation-to-the-usual-treatment-for-her2-positive-breast-cancer-that-had-already-spread-at-diagnosis-100637663","NCT07578116","Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis","Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy","Inclusion Criteria:\n\n* REGISTRATION STEP 1 - SCREENING \\& INITIAL TREATMENT:\n* Participants must have histologically confirmed de novo metastatic (i.e. American Joint Committee on Cancer \\[AJCC\\] stage IV, no prior history of breast cancer) HER2+ breast cancer with 1 to 5 distant metastatic lesions (oligometastatic). Metastatic breast cancer must be histologically confirmed through biopsy of a distant metastatic lesion unless it is not feasible or safe to biopsy a metastatic lesion, then there must be unequivocal evidence of metastasis on imaging and laboratory studies. HER2+ status must be confirmed in the breast tumor and distant metastatic site as defined per NCCN guidelines version 4.2025\n\n  * NOTE: If HER2 positivity at metastatic site is equivocal due to limitations in HER2 analysis in bone, or it is not feasible or safe to biopsy the metastatic lesion, then HER2 positivity based on breast tumor only is acceptable. If there is no breast lesion, HER2+ must be confirmed in at least one metastatic site\n* Participants with brain metastases are eligible if they meet all of the following criteria at baseline:\n\n  * There are 5 or fewer intracranial lesions\n  * Each intracranial lesions is no larger than 2cm in longest dimension\n  * NOTE: The brain is counted as 1 distant site towards the oligometastatic definition. Brain imaging is not required for participants who have no neurological signs or symptoms suggestive of central nervous system (CNS) involvement; however, assessment of neurological symptoms and brain MRI is strongly encouraged to rule out CNS disease\n* Participants must have no known leptomeningeal disease\n* Participants must meet one of the following criteria prior to Step 1 registration:\n\n  * Treatment naïve and planning to initiate standard of care systemic HER2+ targeted treatment OR\n  * Have already initiated standard of care systemic HER2+ targeted treatment and have completed at least one (≥ 1) but no more than three (≤ 3) cycles prior to enrollment, without progression\n\n    * NOTE: Standard of care scans for baseline disease assessment must have been performed within 28 days prior to initiation of treatment\n* Participants must not be receiving or planning to receive any investigational systemic therapy during study before disease progression\n* Participants must not have received whole brain irradiation\n\n  * NOTE: Participants with up to five brain metastases may have received SRS\u002FSRT either before or after initiation of systemic therapy. If lesions are small and asymptomatic and the participant is receiving CNS penetration they may be managed with observation\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod performance status of 0-2\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants must be able to safely receive the physician's choice of standard of care systemic HER2+ targeted treatment per the current Food and Drug Administration (FDA)-approved package insert(s), treating physician's discretion, and institutional guidelines\n* Participants must be candidates for definitive surgical and radiotherapeutic management of locoregional disease opinion per the discretion of the treating physician\n* Participants must be able to receive ablative dose stereotactic body radiation therapy (SBRT) to all metastatic lesions identified at baseline, in the opinion of the treating physician\n* Participants must be offered the opportunity to participate in specimen banking\n* 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 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 CIRB regulations\n* REGISTRATION STEP 2 - COHORT ASSIGNMENT AND RANDOMIZATION:\n* COHORT A: Participants must be registered to Step 2 within 14 days of staging scans performed after completing Step 1 systemic therapy\n* COHORT A: Participants must have standard of care (SOC) staging scans and breast imaging performed following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n* COHORT A: Participants must have experienced partial or complete response in the breast (in the opinion of the treating physician) following 12-24 weeks of initial systemic therapy based on staging scans performed within 14 days prior to Step 2 registration\n\n  * Participants with breast lesion(s) at diagnosis must have a clinical response on breast imaging per the treating physician\n  * Metastatic lesions, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) and bone response criteria, must have at least stable disease\n  * Brain metastases treated with SRS\u002FSRT must have at least stable disease as per Response Assessment in Neuro-Oncology Brain Metastases (RANO BM) and must not require steroid treatment\n  * Participants with no known breast lesions at diagnosis must have at least partial response in the metastatic sites as assessed by RECIST and bone response criteria\n  * NOTE: The same imaging modality must be used as in Step 1\n* COHORT A: Participants must be eligible for definitive surgical and radiotherapeutic management of locoregional disease per the discretion of the treating physician\n* COHORT A: Participants must not have metastatic lesions that are not amenable to ablative dose stereotactic body radiation therapy (SBRT)\n\n  * Lung lesions that completely resolve after systemic therapy will not be targeted with SBRT, as it is not possible to achieve dose build-up\n  * The development of new sclerotic bone lesions after systemic therapy is not to be interpreted as disease progression, and all such lesions should be targeted with SBRT\n* COHORT B: Participants must be registered to Step 2 within 14 days of staging scans performed after completing Step 1 systemic therapy\n* COHORT B: Participants must have standard of care (SOC) staging and breast imaging performed following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n* COHORT B: Participants must experience clinically stable disease or progression following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n\n  * Participants must have progression in metastatic lesions as assessed by RECIST and bone response criteria or may have stable disease in metastatic lesions by RECIST and bone response criteria if there is progression or no clinical response in the breast\n  * Participants with known breast lesion must have progression or no clinical response on breast imaging as per the treating physician\n  * NOTE: The same modality must be used as in Step 1",{"count":51,"type":20},562,[53],"PHASE3","This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and\u002For chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.",[56,57,58],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic HER2-Positive Breast Carcinoma","Oligometastatic Breast Carcinoma","NOT_YET_RECRUITING","2026-05-22",{"date":62,"type":34},"2026-05-27",{"date":64,"type":20},"2027-03-09",{"date":66,"type":20},"2033-05-31",{"name":68,"class":69},"SWOG Cancer Research Network","NETWORK",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":42},"100601558","phase-2-a-vaccine-stemvac-with-standard-endocrine-based-therapy-or-chemotherapy-for-the-treatment-of-metastatic-hormone-receptor-positive-her2-negative-breast-cancer-100601558","NCT07112053","A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer","A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients must be at least ≥ 18 years of age\n* Histologically confirmed hormone receptor positive metastatic breast cancer: Tumors that are positive for estrogen receptor (ER) and\u002For progesterone receptor (PR)\n* HER2-negative or HER2-low will be included and defined as:\n\n  * 0-1+ HER2 expression by immunohistochemistry (IHC) OR\n  * Fluorescence in situ hybridization (FISH) negative OR\n  * HER2 2+ and FISH negative\n  * HER2 low per standard of care in breast cancer\n* Patients should be receiving the following therapies to be eligible for the study:\n\n  * Cohort 1: First or second line of endocrine therapy in the metastatic setting, in combination with a CDK4\u002F6 inhibitor. Patients must have completed at least 2 cycles of CDK4\u002F6 inhibitor. Patients who have stopped endocrine therapy for intolerance but remain on abemaciclib monotherapy will be considered for enrollment at the PI's discretion\n  * Cohort 2: Progressed on endocrine-based therapies and after completion of at least 1 cycle of capecitabine\n* Subjects with Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1\n* Willing to undergo up to two serial biopsies while on study\n* Have at least 1 site of disease confirmed by the treating oncologist that could be biopsied during treatment\n* White blood cell (WBC) ≥ 2000\u002Fmm\\^3 (within 28 days of receiving the study vaccine)\n* Lymphocyte count ≥ 500\u002Fmm\\^3 (within 28 days of receiving the study vaccine)\n* Absolute neutrophil count (ANC) ≥ 800\u002FµL (within 28 days of receiving the study vaccine)\n* Platelets ≥ 75,000\u002FµL (within 28 days of receiving the study vaccine)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be ≤ 3.0 mg\u002FdL (within 28 days of receiving the study vaccine)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN) (within 28 days of receiving the study vaccine)\n* Creatinine ≤ 2.0 mg\u002FdL or creatinine clearance \\> 30 mL\u002Fmin (within 28 days of receiving the study vaccine)\n* Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal. Effective methods of contraception must be used throughout the study and until the end of treatment on study\n* Must have recovered from major infections and\u002For surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment\n\nExclusion Criteria:\n\n* Patients with any of the following cardiac conditions:\n\n  * Symptomatic restrictive cardiomyopathy\n  * Dilated cardiomyopathy\n  * Unstable angina within 4 months prior to enrollment\n  * New York Heart Association functional class III-IV heart failure on active treatment\n  * Symptomatic pericardial effusion\n  * Uncontrolled hypertension\n  * Uncontrolled cardiac arrhythmias\n* Patients with any autoimmune disease\u002Fcomorbidity that require chronic steroids or immunosuppressants\n* A non-breast malignancy requiring radiation or systemic therapy within last 5 years\n* Known hypersensitivity reaction to the granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF\n* Pregnant or breast feeding\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive), or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n* Major surgery within the 4 weeks prior to initiation of study vaccine\n* Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30 days prior to starting study drug will be excluded\n* Patient is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and\u002For therapeutic devices, or investigational drug\n\n  * NOTE: Biomarker or tissue collection or any other non-interventional clinical trial enrollment is allowed\n* Must be 14 days between a non-study vaccine and any STEMVAC vaccination\n\n  * NOTE: The minimum of 14 days does not apply to the tetanus and diphtheria (Td) vaccine\n* Any condition that may interfere with the patient's participation in the study per treating oncologist",{"count":78,"type":20},40,[23],"This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) with a CDK4\u002F6 targeted drug therapy, or with the chemotherapy drug capecitabine, in treating patients with hormone receptor (HR)-positive, HER2-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that cancer cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Standard ET is treatment that adds, blocks, or removes hormones in order to slow or stop the growth of cancer. Standard CDK4\u002F6 inhibitors, including abemaciclib, may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Giving STEMVAC in combination with standard ET or chemotherapy may be an effective treatment for metastatic HR positive, HER2 negative breast cancer.",[56,82,83],"Metastatic HER2-Negative Breast Carcinoma","Metastatic Hormone Receptor-Positive Breast Carcinoma","2026-04-01",{"date":86,"type":34},"2026-04-06",{"date":88,"type":34},"2025-11-17",{"date":90,"type":20},"2028-12-31",{"name":92,"class":41},"University of Washington",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":101,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":42},"100432776","phase-2-extremely-hypofractionated-intensity-modulated-stereotactic-body-radiotherapy-for-the-treatment-of-prostate-cancer-with-rising-psa-after-radical-prostatectomy-100432776","NCT04915508","Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy","Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)","EXCALIBUR","Inclusion Criteria:\n\n* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent\n* Presence of any ONE of the following:\n\n  * Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)\n  * Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng\u002FmL\n  * Intermediate- or high-risk Decipher genomic classifier score\n  * Identification of prostate cancer in \\>= 1 lymph node at the time of prostatectomy (pN+ disease)\n* CT scan and MRI of the pelvis within 120 days prior to enrollment \\[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \\\u003C 1.0 ng\u002FmL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\\]\n* Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \\> 1.0 ng\u002FmL\n* Age \\>= 18\n* Karnofsky performance status (KPS) \\>= 70 and\u002For Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Ability to understand, and willingness to sign, the written informed consent\n\nExclusion Criteria:\n\n* Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Prior pelvic radiotherapy\n* History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia","MALE",{"count":103,"type":20},102,[23],"This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.",[107,108,109,110,111,112],"Prostate Adenocarcinoma","Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage IIIC Prostate Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","2025-06-17",{"date":115,"type":34},"2025-06-22",{"date":117,"type":34},"2021-06-23",{"date":119,"type":20},"2027-08-01",{"name":121,"class":41},"Jonsson Comprehensive Cancer Center",""]