OncoMatch/Clinical Trials/NCT06790693
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Is NCT06790693 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Inavolisib and CDK4/6i for breast cancer.
Treatment: Inavolisib · CDK4/6i · Letrozole — This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA mutation
Confirmation of biomarker eligibility
Required: ESR1 overexpression (ER-positive)
Documented ER-positive and/or progesterone receptor-positive tumor according to ASCO/CAP guidelines
Required: PR (PGR) overexpression (PR-positive)
Documented ER-positive and/or progesterone receptor-positive tumor according to ASCO/CAP guidelines
Required: HER2 (ERBB2) wild-type (HER2-negative)
Documented HER2-negative tumor according to ASCO/CAP guidelines
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: adjuvant/neoadjuvant endocrine therapy allowed if at least 2 years duration and disease-free interval of at least 1 year since completion
Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
Cannot have received: hematopoietic stem cell or bone marrow transplantation
Prior hematopoietic stem cell or bone marrow transplantation
Lab requirements
Blood counts
Adequate hematologic function within 14 days prior to initiation of study treatment
Kidney function
Adequate organ function within 14 days prior to initiation of study treatment
Liver function
Adequate organ function within 14 days prior to initiation of study treatment
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Disney Family Cancer Center · Burbank, California
- Scripps Health · La Jolla, California
- Cancer and Blood Specialty Clinic · Los Alamitos, California
- Ellison Institute of Technology · Los Angeles, California
- Palo Alto Medical Foundation Research Center · Palo Alto, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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