OncoMatch/Clinical Trials/NCT07174336
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
Is NCT07174336 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for breast neoplasms.
Treatment: LY4064809 · Ribociclib · Palbociclib · Abemaciclib · Anastrozole · Letrozole · Exemestane · Fulvestrant — The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA activating mutation
evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay
Required: ESR1 expression (≥1% tumor cells stained positive)
Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive
Required: PR (PGR) expression (≥1% tumor cells stained positive)
Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive
Required: HER2 (ERBB2) wild-type
HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Alaska Oncology and Hematology · Anchorage, Alaska
- Ironwood Cancer & Research Centers · Chandler, Arizona
- Mayo Clinic in Arizona - Phoenix · Phoenix, Arizona
- The University of Arizona Cancer Center - North Campus · Tucson, Arizona
- Genesis Cancer and Blood Institute · Hot Springs, Arkansas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07174336 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require PIK3CA?
Yes, PIK3CA activating mutation is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression 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