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 (Jun 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
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 →Frequently asked questions
Is NCT07174336 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior local or systemic antineoplastic therapy or investigational anticancer agent disqualifies patients from enrollment.
Does this trial require PIK3CA?
Yes, PIK3CA activating mutation is a required biomarker for enrollment.
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.
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