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Clinical trial

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor

NCT06982521 is registered in ClinicalTrials.gov with Relay Therapeutics, Inc. as lead sponsor.

NCT NCT06982521
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor
Lead sponsor
Relay Therapeutics, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
August 26, 2025
Completion date
December 31, 2031
Enrollment
540 (estimated)
Sites
243

Conditions

As the registry lists them; a condition with its own page is linked.

advanced breast cancer, breast cancer, her2- negative breast cancer, hormone receptor positive tumor, metastatic breast cancer, pik3ca mutation