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Study identifier: NCT06982521 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

Condition: PIK3CA Mutation · HER2- Negative Breast Cancer · Hormone Receptor Positive Tumor  ·  Sponsor: Relay Therapeutics, Inc.

PhasePhase 3
Planned participants540
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

This description comes directly from the study's public registry record.

Talk to the study team

Relay Therapeutics, Inc  ·  617-322-0731  ·  ClinicalTrials@relaytx.com

Always discuss trial participation with your own doctor first.

Locations (211)

Banner MD Anderson Cancer CenterGilbert, Arizona, United StatesRecruiting
Beverly Hills Cancer CenterBeverly Hills, California, United StatesRecruiting
City of Hope National Medical CenterDuarte, California, United StatesRecruiting
Cedars-Sinai Medical CenterLos Angeles, California, United StatesRecruiting
Stanford Women's Cancer CenterPalo Alto, California, United StatesRecruiting
University of California, Davis Comprehensive Cancer CenterSacramento, California, United StatesRecruiting
University of California San Diego Moores Cancer CenterSan Diego, California, United StatesRecruiting
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United StatesRecruiting
Kaiser Permanente Medical CenterVallejo, California, United StatesRecruiting
Rocky Mountain Cancer Centers, LLPLongmont, Colorado, United StatesRecruiting
Yale-New Haven Hospital-Yale Cancer CenterNew Haven, Connecticut, United StatesRecruiting
Medical Oncology Hematology Consultants, P.A.Newark, Delaware, United StatesRecruiting

+ 199 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06982521