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LY4064809 / Ribociclib / Palbociclib · Phase 3 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial registration evaluating tersolisib (LY4064809/STX-478), a PIK3CA inhibitor, in combination with standard anti-cancer agents as first-line therapy for advanced HR+/HER2− breast cancer in patients with PIK3CA mutations. The study is currently recruiting and has not yet reported results; the primary endpoints are Overall Response Rate (Part 1) and Progression-Free Survival (Part 2), with follow-up estimated to 5 years.
Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Breast Neoplasms, Neoplasm Metastasis; age from 18 Years. Intervention: LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part…; LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part…. Compared with: Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2) — Placebo Comparator. n = 800. 360 sites across 19 countries.
Planned enrollment of 800 participants with advanced HR+/HER2− breast cancer and PIK3CA genetic alterations Primary endpoint Part 1: Overall Response Rate (ORR) as percentage with confirmed CR or PR through disease progression or death (estimated up to 5 years) Primary endpoint Part 2: Progression-Free Survival from baseline to objective progression or death (estimated up to 5 years)
This is a registry record with no results posted; outcomes, effect sizes, and safety data are not yet available
Once results are reported, this trial will inform whether the addition of tersolisib to standard endocrine or CDK4/6 inhibitor therapy improves response rates and progression-free survival in PIK3CA-mutant advanced breast cancer. Clinicians should await outcome publication before interpreting clinical utility.
This is a Phase 3 RCT registration with no results posted; the study is actively recruiting and designed to test a novel PIK3CA inhibitor in advanced breast cancer, but outcome data are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
Once results are reported, this trial will inform whether the addition of tersolisib to standard endocrine or CDK4/6 inhibitor therapy improves response rates and progression-free survival in PIK3CA-mutant advanced breast cancer. Clinicians should await outcome publication before interpreting clinical utility.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07174336). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Breast Neoplasms, Neoplasm Metastasis. Interventions: DRUG: LY4064809; DRUG: Placebo; DRUG: Ribociclib; DRUG: Palbociclib; DRUG: Abemaciclib; DRUG: Anastrozole; DRUG: Letrozole; DRUG: Exemestane; DRUG: Fulvestrant. Primary outcome measures: (Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) , Baseline through disease progression or death (Estimated up to 5 years); (Part 2): Progression-Free Survival , Baseline to objective progression or death due to any cause (Estimated up to 5 years). Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.