OncoMatch/Clinical Trials/NCT07405801
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Is NCT07405801 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Inavolisib and Ribociclib for breast cancer.
Treatment: Inavolisib · Ribociclib · Fulvestrant — A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>=1% of tumor cells stained positive)
estrogen receptor (ER)-positive ... defined as >=1% of tumor cells stained positive
Required: PR (PGR) overexpression (>=1% of tumor cells stained positive)
progesterone receptor (PR)-positive ... defined as >=1% of tumor cells stained positive
Required: PIK3CA wild-type
lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation
Required: CHR8P heterozygous loss
presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)
Prior therapy
Must have received: endocrine therapy (aromatase inhibitor, tamoxifen) — adjuvant
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07405801 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require PIK3CA?
Yes, PIK3CA wild-type 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