[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hr-positiveher-2-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hr-positiveher-2-negative-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,59,94],{"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":31,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100622429","phase-1-a-study-of-mutant-selective-inhibitor-cgt6297-in-patients-with-advanced-solid-tumors-100622429",false,"NCT07383506","A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors","A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations","Inclusion Criteria:\n\n1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and\u002For tumor:\n\n   1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer\n   2. Phase 1b Cohort 2, participants must have HR-positive\u002FHER2-negative or HER2-low breast cancer (immunohistochemistry \\[IHC\\] and in-situ hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria)\n   3. Phase 1b Cohort 3 will allow all solid tumors that do not meet criteria for Phase 1b Cohorts 1 or 2, including head and neck cancers, other gynecological cancers, colorectal cancers harboring PIK3CA mutations\n2. Meet prior treatment requirement of:\n\n   1. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n   2. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition\n3. Have at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1\n5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits\n6. Resolution of acute toxicities from prior anticancer therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities (other than parameters specified in screening testing as outlined below), as determined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) v5.0.\n7. Have an ejection fraction ≥50%\n\nExclusion Criteria:\n\n1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.\n2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug\n3. Treatment with radiotherapy ≤2 weeks before the first dose of study drug.\n4. Clinically significant cardiac disease\n5. Ongoing or planned long-term (≥4 consecutive weeks) treatment with glucocorticoid steroids at greater than physiologic dosing (defined as equivalent to \\>20 mg\u002Fday prednisone)\n6. Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg\u002FdL and HbA1c ≥7.0%; antihyperglycemic medical management permitted with the exception of insulin)\n7. Previous molecular testing (NGS or PCR) showed tumor with the following mutations: mutations\u002Fdeletions in PTEN or activating mutations in AKT, HRAS\u002FKRAS\u002FNRAS, EGFR, and BRAF","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations",[26,27,28,29,30],"PIK3CA Mutations","Advanced Solid Tumors, Adult","Endometrial Cancer","HR Positive\u002FHER-2 Negative Breast Cancer","HER2-low Breast Cancer",[32,33,34,35,26,36,28,37,38,39,40,41,42,43,44,30,45],"HER2","PI3K","Mutant-Selective Inhibitor","Advanced solid tumors","PIK3CA SNVs","Breast Cancer","HR+\u002FHER2 Negative breast cancer","HR+\u002FHER2 (-) breast cancer","HR+\u002FHER2 low breast cancer","PI3KCA Genetic Alterations","PI3KCA Point Mutations","PI3KCA Gene Short Variants","PI3KCA active alteration","Phase 1a\u002F1b","RECRUITING","2026-06-30",{"date":49,"type":50},"2026-07-01","ACTUAL",{"date":52,"type":20},"2026-06",{"date":54,"type":20},"2029-08",{"name":56,"class":57},"Cogent Biosciences, Inc.","INDUSTRY",4,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100609178","evaluating-minimal-residual-disease-mrd-through-longitudinal-circulating-tumor-dna-ctdna-profiling-in-breast-malignancies-100609178","NCT07211178","Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies","GEMINI Breast","Inclusion Criteria:\n\nAll Cohorts:\n\n1. Willing and able to participate in the research and provide biospecimens\n2. Willing and able to provide informed consent\n3. Must be diagnosed with breast cancer\n\nCohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-\n\n1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)\n2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n\nCohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients.\n\nCohort 1C: Triple Negative Breast Cancer\n\n1\\. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease).\n\nCohort 2: Adjuvant Therapy \u002F Surveillance Cohort 2A: Newly Diagnosed HR+,HER2-\n\n1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)\n2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n3. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 2B: HER2+\n\n1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)\n2. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 2C: Triple Negative Breast Cancer\n\n1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)\n2. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 3: 5-Years Post-Diagnosis Surveillance (NED)\n\n1. A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).\n2. No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.\n3. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n\nExclusion Criteria:\n\n1. Not willing or able to adhere with the study procedures\n2. Active secondary malignancy\n3. Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.","99 Years",{"count":68,"type":20},900,"OBSERVATIONAL","For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.\n\nA way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working.\n\nUltimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.",[37,72,29,73,74],"TNBC - Triple-Negative Breast Cancer","HER2 + Breast Cancer","Early Stage Breast Cancer",[76,77,78,79,80,74,81,82,83],"Minimal Residual Disease","MRD","Next generation sequencing","NGS","ctDNA","TNBC - Triple Negative Breast Cancer","HR positive \u002F HER-2 negative breast cancer","HER2+ breast cancer","2026-06-10",{"date":86,"type":50},"2026-06-12",{"date":88,"type":50},"2025-10-27",{"date":90,"type":20},"2033-12",{"name":92,"class":57},"Tempus AI",14,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100600857","phase-2-efti-in-patients-with-hormone-receptor-positiveher2-neg-breast-cancer-100600857","NCT07102940","Efti in Patients With Hormone Receptor Positive\u002FHER2-neg Breast Cancer","Eftilagimod Alpha in Combination With Neoadjuvant Chemotherapy in Patients With Hormone Receptor Positive\u002FHER2-neg Breast Cancer","Inclusion Criteria:\n\n* Have histologically documented HR+\u002FHER2 neg (defined as ER expression \\>10% by IHC and\u002For PR expression \\> 10% by IHC and HER2 0 or 1+ or 2+ by IHC or FISH ratio \\\u003C2 or HER2 gene copy number of \\\u003C6).\n* Clinical early-stage breast cancer (Stage I-III) and a candidate for NAC.\n* Be informed of the investigational nature of the trial and all pertinent aspects of the trial.\n* Have ECOG performance status of 0-2.\n* Have the ability to understand and the willingness to sign a written informed -consent document in accordance with institutional and federal guidelines.\n* Be ≥ 21 years of age.\n* Have serum creatinine \\\u003C 1.5 x institutional upper limit of normal (IULN) or a calculated creatinine clearance ≥ 30ml\u002Fmin (calculated by Cockcroft Gault equation), bilirubin ≤ 2.0, and an SGOT\u002FSGPT\u002Falkaline phosphatase ≤ 2.0 x IULN.\n* Have adequate bone marrow function (ANC \\>1000\u002FμL, Platelets \\>100,000\u002Fml, Hemoglobin \\>10gm\u002FdL).\n* Women of childbearing potential or male patients of reproductive potential with female partners of childbearing potential must not consider getting pregnant and must avoid pregnancy during the trial and for at least 6 months after the last dose of trial treatment. Female and male patients of reproductive potential must practice highly effective methods of contraception with their partners, if of reproductive potential, during treatment and for 6 months following last dose of treatment with IP.\n\nExclusion Criteria:\n\n* Receiving concurrent anti-neoplastic therapy for another malignancy\n* Known documented or suspected hypersensitivity to the components of the trial drug or analogs.\n* Stage IV or patients otherwise not indicated for surgery. Patients with oligometastatic disease who are undergoing curative intent treatment are eligible as long as curative intent surgery is planned.\n* A woman of child-bearing potential who has a positive serum pregnancy test (within 72 hours) prior to Day 1.\n* Breastfeeding\n* Serious infection within 4 weeks prior to Day 1 or active acute or chronic infection needing IV antibiotics. Note: Subjects treated for moderately severe infections with oral antibiotics only, may be included, based on consultation with trial Investigator.\n* Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial treatment including: myocardial infarction, severe\u002Funstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ≥ 2, atrial fibrillation \\> grade 2 not controlled by a pacemaker, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (NYHA III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 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 and is allowed.\n* Receives continuous systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to Day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease.\n* Live vaccine within 30 days of planned Day 1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Note: non-live vaccines (e.g., non-live influenza vaccine, non-live COVID-19 vaccine) can be given until 3 days prior to planned Day 1.\n* Prior anti-LAG-3 therapy (e.g. anti-LAG-3 antibodies).\n* Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.\n* Has had an allogenic tissue\u002Fsolid organ transplant.","21 Years",{"count":103,"type":20},50,[105],"PHASE2","The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+\u002FHER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.",[37,108,29,109],"HER 2 Negative Breast Cancer","Stage 1-3",[111,112,32,113],"breast","cancer","HR positive","NOT_YET_RECRUITING",{"date":116,"type":50},"2026-06-11",{"date":118,"type":20},"2026-09-01",{"date":120,"type":20},"2028-08",{"name":122,"class":123},"George Washington University","OTHER"]