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 (Jun 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
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type (negative)
Required: ESR1 positive (positive)
Required: PR (PGR) positive (positive)
Required: PIK3CA mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for locally advanced unresectable or metastatic breast cancer
Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
Cannot have received: hematopoietic stem cell transplant
Prior hematopoietic stem cell or bone marrow transplantation
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Dignity Health Cancer Institute · Phoenix, Arizona
- 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06790693 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for locally advanced unresectable or metastatic breast cancer, hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR positive is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify