OncoMatch/Clinical Trials/NCT07054190
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Is NCT07054190 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Inavolisib and Ribociclib for breast cancer.
Treatment: Inavolisib · Ribociclib · Letrozole — This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA mutation
Confirmed PIK3CA mutation
Required: ESR1 overexpression (ER-positive)
Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Required: HER2 (ERBB2) wild-type (HER2-negative)
Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
Required: MKI67 overexpression (Ki-67 score >=5%)
Documented Ki-67 score >=5% as per local assessment
Disease stage
Required: Stage II, III
Excluded: Stage IV
Prior therapy
Cannot have received: systemic therapy
Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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