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Anatomic Stage III Breast Cancer AJCC V8 / Alpelisib / Advanced Malignant Solid Neoplasm · Phase 2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
ComboMATCH is a Phase 2 NCI-sponsored screening trial designed to enroll approximately 2900 patients with locally advanced or advanced solid tumors and match them to targeted therapies based on tumor genetic testing. This registry record documents the study design and enrollment targets but does not report clinical outcomes, efficacy, or safety results.
Phase 2, Interventional, Randomized, Single Group, Open label, Screening purpose. Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm…. Intervention: EAY191-A2 (Cohort 1, Arm A); EAY191-A2 (Cohort 2, Arm B); EAY191-A2 (Cohort 2, Arm C); EAY191-A2 (Cohort 3, Arm D); EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetini…; EAY191-A3 Monotherapy Cohort 1 (binimetinib); EAY191-A6 Arm I…. Compared with: EAY191-E5 Cohort I Arm B (sotorasib) — Active Comparator; EAY191-N4 Arm II (RAS pathway mutations) — Active Comparator; EAY191-N5 Arm I (neratinib maleate) — Active Comparator. n = 2,900. 482 sites: United States, Puerto Rico.
Planned enrollment of 2900 estimated participants across multiple solid tumor types Primary outcomes are accrual, assignment, and enrollment rates measured up to 8 years Genetic testing-directed matching to targeted drugs including alpelisib, binimetinib, olaparib, palbociclib, sotorasib, and others
No clinical efficacy, safety, or outcome data are reported in this registry record Primary outcomes are procedural (accrual, enrollment rates) not clinical (response, survival, toxicity)
This registry entry documents an ongoing screening infrastructure trial, not a completed efficacy trial. Clinicians should await publication of ComboMATCH enrollment outcomes and downstream treatment trial results before drawing conclusions about the clinical utility of genetic testing-directed matching in solid tumors.
This is a Phase 2 screening trial registry record with no reported results; it describes planned enrollment and procedural outcomes only, not clinical efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
This registry entry documents an ongoing screening infrastructure trial, not a completed efficacy trial. Clinicians should await publication of ComboMATCH enrollment outcomes and downstream treatment trial results before drawing conclusions about the clinical utility of genetic testing-directed matching in solid tumors.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT05564377). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 2900 participants (ESTIMATED). Conditions: Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm. Interventions: DRUG: Alpelisib; DRUG: Binimetinib; PROCEDURE: Biopsy Procedure; PROCEDURE: Biospecimen Collection; PROCEDURE: Bone Marrow Aspiration; PROCEDURE: Bone Marrow Biopsy; PROCEDURE: Bone Scan; PROCEDURE: Computed Tomography; PROCEDURE: Echocardiography Test; DRUG: Fluorouracil; DRUG: Fulvestrant; DRUG: Ipatasertib; DRUG: Leucovorin; PROCEDURE: Magnetic Resonance Imaging; PROCEDURE: Multigated Acquisition Scan; PROCEDURE: Mutation Carrier Screening; DRUG: Neratinib Maleate; DRUG: Nilotinib Hydrochloride Monohydrate; DRUG: Olaparib; DRUG: Oxaliplatin; DRUG: Paclitaxel; DRUG: Palbociclib; BIOLOGICAL: Panitumumab; PROCEDURE: Positron Emission Tomography; DRUG: Selumetinib Sulfate; DRUG: Sotorasib. Primary outcome measures: Accrual of patients to ComboMATCH treatment trials , Up to 8 years; Assignment of patients to ComboMATCH treatment trials , Up to 8 years; Enrollment rates to ComboMATCH treatment trials , Up to 8 years. Brief summary: This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.