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 (May 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
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA activating mutation
Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.
Required: ESR1 overexpression (ER+ (≥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) overexpression (PR+ (≥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) negative (IHC 1+ or 2+ with negative FISH) (IHC 1+ or 2+ with negative FISH)
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
Prior therapy
Cannot have received: local or systemic antineoplastic therapy or investigational anticancer agent
Exception: within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days
Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.
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
- Highlands Oncology Group · Springdale, Arkansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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