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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

Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 28 May 2025

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At a glance

  • Drugs Fulvestrant (Primary) ; RLY-2608 (Primary) ; Capivasertib
  • Indications HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ReDiscover-2
  • Sponsors Relay Therapeutics

Most Recent Events

  • 21 May 2025 Status changed from planning to not yet recruiting.
  • 26 Feb 2025 According to a Relay Therapeutics media release, Approximately 780 million dollar in cash,cashequivalents and investments at end of Q4 2024, which will be prioritized to fully fund the execution of the ReDiscover-2 Phase 3 trial.
  • 26 Feb 2025 According to a Relay Therapeutics media release, company has conducted an end of Phase 2 meeting with the Food and Drug Administration (FDA) and announces the Phase 3 trial design, dose, and plans to initiate the trial in mid-2025.

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