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

Source: https://onco.cc/trials/nct06982521/  
OnCo record `nct06982521` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing Zovegalisib in HR-positive / HER2-negative breast cancer, now recruiting.

## Summary

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT06982521, led by Relay Therapeutics, and recruiting on the registry. Official title: A Phase 3 Open-Label Randomised 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. Planned enrolment is 540 participants (estimated). The study started in 2025-08-26 and primary completion is expected in 2028-04-30. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Also known as: ReDiscover-2
- Tags: ctgov-ingest
- Registry id: NCT06982521
- Phase: 3
- Setting: 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
- Sponsor: Relay Therapeutics
- Enrolled: 540

## Sources

- ClinicalTrials.gov NCT06982521: https://clinicaltrials.gov/study/NCT06982521

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- drugs: [Zovegalisib](https://onco.cc/drugs/zovegalisib/)
- companies: [Relay Therapeutics](https://onco.cc/companies/relay-therapeutics/)

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