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NCT07174336

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 27 versions: 27 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 361 → 364 locations
  2. Study sites: 361 to 363
  3. Study sites: 360 to 361
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 2 of 14 entries
  4. Study sites: 359 to 360v24
  5. Trial sites expanded: 353 → 359 locationsv23
  6. Trial sites expanded: 346 → 353 locationsv22
  7. Enrollment reduced: 920 → 800 participants
    • Trial sites expanded: 338 → 346 locations
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 15 to 14
    v21
  8. Trial sites expanded: 330 → 338 locationsv20
  9. Trial sites expanded: 327 → 330 locationsv19
  10. Trial sites expanded: 324 → 327 locationsv18
  11. Study sites: 323 to 324v17
  12. Trial sites expanded: 317 → 323 locationsv16
  13. Study Status, Referencesv15
  14. Trial sites expanded: 307 → 317 locationsv14
  15. Study sites: 303 to 307v13
  16. Study sites: 300 to 303v12
  17. Study sites: 278 to 300v11
  18. Study sites: 240 to 278v10
  19. Study title revisedv9
  20. Study sites: 229 to 240v8
  21. Study title expanded, about 1 wordv7
  22. Study sites: 225 to 229v6
  23. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2025 to Dec 22, 2025
    • Site details revised at 225 of 225 sites
    v5
  24. Start date: Oct 27, 2025 to Dec 2025
    • Trial status: Recruiting to Not Yet Recruiting
    • Study sites: 186 to 225
    v4
  25. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 46 to 186
    • Start date changed from estimate of Oct 2025 to Oct 27, 2025
    • Eligibility criteria expanded, about 70 words
    v3
  26. Study sites: 30 to 46v2
  27. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

(Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)
Timeframe: Baseline through disease progression or death (Estimated up to 5 years)
(Part 2): Progression-Free Survival
Timeframe: Baseline to objective progression or death due to any cause (Estimated up to 5 years)

Secondary (14)

(Part 1): Disease Control Rate (DCR)
(Part 1): Time to Response (TTR)
(Parts 1 and 2): Duration of Response (DOR)
(Part 1): PFS
(Parts 1 and 2): Overall Survival (OS)
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(Parts 1 and 2): Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD Lasting Greater than or Equal to Six Months
(Parts 1 and 2): PK: Average Plasma Concentrations of tersolisib
(Part 2): Progression-Free Survival after Subsequent Line of Treatment (PFS2)
(Part 2): Progression-Free Survival (PFS)
(Part 2): Objective Response Rate (ORR)
(Part 2): Time to Chemotherapy (TTC)
(Part 2): Chemotherapy-Free Survival
(Part 2): Change in Overall Health-related Quality of Life (HRQoL) as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Subscale
(Part 2): Change in Physical Function as measured by the EORTC QLQ-C30 Physical Functioning Subscale

Arms and interventions

LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 1)Experimental

LY4064809 given orally in one of two doses in combination with investigator's choice of CDK4/6 inhibitor given orally and ET given orally or intramuscularly

LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)Experimental

LY4064809 given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly

Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)Placebo comparator

Placebo given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly

Drugs: LY4064809, Placebo, Ribociclib, Palbociclib, Abemaciclib, Anastrozole, Letrozole, Exemestane, Fulvestrant

Sites

364 sites in 19 countries

United States 132, Spain 28, Japan 25, Germany 23, China 19, Brazil 16, France 16, Greece 14, Argentina 13, Italy 12, Turkey (Türkiye) 11, Australia 10, South Korea 10, United Kingdom 8, Belgium 7, Taiwan 7, Ireland 6, Canada 4, Singapore 3