NCT06982521 (ReDiscover-2) is a Phase 3 clinical trial of RLY-2608 in PIK3CA Mutation, sponsored by Relay Therapeutics, Inc..

Who is sponsoring NCT06982521?

NCT06982521 is sponsored by Relay Therapeutics, Inc..

What drugs are being tested in NCT06982521?

Interventions in NCT06982521: RLY-2608, Capivasertib, Fulvestrant.

What condition does NCT06982521 study?

NCT06982521 studies PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer.

Is NCT06982521 still recruiting?

NCT06982521 is currently recruiting now. Last updated 2 April 2026.

Last reviewed 2026-04-02 · How we verify

NCT06982521: ReDiscover-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 2 April 2026

What this trial tests

Phase 3 trial testing RLY-2608 in PIK3CA Mutation in 540 participants. Currently enrolling.

Timeline

26 August 2025

Primary endpoint
30 April 2028

31 December 2031

Quick facts

Lead sponsor	Relay Therapeutics, Inc.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	540
Start date	26 August 2025
Primary completion	30 April 2028
Estimated completion	31 December 2031
Sites	120 locations across Hong Kong, Italy, Taiwan, Poland, South Korea, Denmark, Netherlands, Belgium

Drugs / interventions tested

RLY-2608 — full drug profile →
Capivasertib — full drug profile →
Fulvestrant (fulvestrant) — full drug profile →

Conditions studied

PIK3CA Mutation — all drugs for PIK3CA Mutation →
HER2- Negative Breast Cancer — all drugs for HER2- Negative Breast Cancer →
Hormone Receptor Positive Tumor — all drugs for Hormone Receptor Positive Tumor →
Breast Cancer — all drugs for Breast Cancer →

Sponsor

Relay Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with PIK3CA Mutation or HER2- Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Discovering anticancer drug target combinations via network-informed signaling-based approach.
Yavuz BR, Jang H, Nussinov R. · · 2025 · cited 3× · PMID 41107466 · DOI 10.1038/s43856-025-01150-9
Beyond CDK4/6 Inhibition: Current Strategies in Hormone Receptor-Positive Metastatic Breast Cancer.
Cetin B, Erdem D, Karaman I, Gumusay O. · · 2026 · PMID 41999452 · DOI 10.1007/s11864-026-01391-3
Navigating Treatment Sequencing in Advanced HR+/HER2- Breast Cancer After CDK4/6 Inhibitors: Biomarker-Driven Strategies and Emerging Therapies.
Narvaez DP, Cescon DW. · · 2025 · PMID 41226406 · DOI 10.3390/ijms262110366
Conventional and alternative approaches for targeting PIK3CA and PTEN alterations in head and neck, breast, and other cancers.
Gencel-Augusto J, Grandis JR, Johnson DE. · · 2026 · PMID 41022681 · DOI 10.1016/j.jbior.2025.101117

Verify or expand the search:

Other trials of RLY-2608

Trials testing the same drug.

NCT05216432 — First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tu · Phase 1 · recruiting

Other recruiting trials for PIK3CA Mutation

Currently open trials in the same condition.

NCT05216432 — First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tu · Phase 1 · recruiting

Other Relay Therapeutics, Inc. trials

Trials by the same sponsor.

NCT05759949 — First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors · Phase 1 · completed
NCT05216432 — First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tu · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06982521 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Relay Therapeutics, Inc.
Last refreshed: 2 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06982521.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing