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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06982521

Public ClinicalTrials.gov record NCT06982521. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 10, 2026, 4:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Study identification

NCT ID
NCT06982521
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Relay Therapeutics, Inc.
Industry
Enrollment
540 participants

Conditions and interventions

Interventions

  • Capivasertib Drug
  • Fulvestrant Drug
  • RLY-2608 Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 25, 2025
Primary completion
Apr 29, 2028
Completion
Dec 30, 2031
Last update posted
May 7, 2026

2025 – 2031

United States locations

U.S. sites
51
U.S. states
27
U.S. cities
44
Facility City State ZIP Site status
Banner MD Anderson Cancer Center Gilbert Arizona 85234 Recruiting
Beverly Hills Cancer Center Beverly Hills California 90211 Recruiting
City of Hope National Medical Center Duarte California 91010 Recruiting
Cedars-Sinai Medical Center Los Angeles California 90048 Recruiting
Stanford Women's Cancer Center Palo Alto California 94304 Recruiting
University of California, Davis Comprehensive Cancer Center Sacramento California 95817 Recruiting
University of California San Diego Moores Cancer Center San Diego California 92037 Recruiting
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center San Francisco California 94158 Recruiting
Kaiser Permanente Medical Center Vallejo California 94589 Recruiting
Rocky Mountain Cancer Centers, LLP Longmont Colorado 80504 Recruiting
Yale-New Haven Hospital-Yale Cancer Center New Haven Connecticut 06510 Recruiting
Medical Oncology Hematology Consultants, P.A. Newark Delaware 19713 Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia 20007 Recruiting
AdventHealth Altamonte Springs Florida 32701 Recruiting
Florida Cancer Specialists-South Fort Myers Florida 33901 Recruiting
Cancer Care Centers of Brevard, Inc Palm Bay Florida 32909 Recruiting
Rush University Medical Center Chicago Illinois 60607 Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois 60611 Recruiting
Community Health Network, Inc Indianapolis Indiana 46250 Recruiting
University of Kansas Cancer Center Westwood Kansas 66205 Recruiting
Cancer Center of Kansas Wichita Kansas 67214 Recruiting
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins Baltimore Maryland 21287 Recruiting
Tufts Medical Center Boston Massachusetts 02111 Recruiting
Dana Farber Cancer Institute Boston Massachusetts 02215 Recruiting
University of Michigan Ann Arbor Michigan 48109 Recruiting
Profound Research LLC Royal Oak Michigan 48073 Recruiting
Minnesota Oncology Hematology, P.A. Minneapolis Minnesota 55404 Recruiting
University of Mississippi Medical Center Jackson Mississippi 39213 Recruiting
Washington University School of Medicine- Siteman Cancer Center St Louis Missouri 63108 Recruiting
Nebraska Cancer Specialists Omaha Nebraska 68130 Recruiting
Renown Health Medical Oncology Reno Nevada 89502 Recruiting
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey 07601 Recruiting
Rutgers Cancer Institute New Brunswick New Jersey 08901 Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health New York New York 10016 Recruiting
Icahn School of Medicine at Mount Sinai New York New York 10029 Recruiting
Columbia University Irving Medical Center New York New York 10032 Recruiting
Memorial Sloan-Kettering Cancer Center New York New York 10065 Recruiting
Oregon Health & Science University, Knight Cancer Institute Portland Oregon 97210 Recruiting
Avera Cancer Institute Sioux Falls South Dakota 57105 Recruiting
Tennessee Cancer Specialists Knoxville Tennessee 37909 Recruiting
Tennessee Oncology, PLLC Nashville Tennessee 37203 Recruiting
Texas Oncology Central/South Austin Texas 78731 Recruiting
Texas Oncology DFW Dallas Texas 75246 Recruiting
University of Texas Southwestern Medical Center Dallas Texas 75390 Recruiting
Houston Methodist Hospital Cancer Center Houston Texas 77030 Recruiting
The University of Texas M.D. Anderson Cancer Center Houston Texas 77030 Recruiting
Baylor Scott and White Medical Center Temple Texas 76508 Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah 84112 Recruiting
Virginia Cancer Specialists, PC Fairfax Virginia 22031 Recruiting
Virginia Oncology Associates Norfolk Virginia 23502 Recruiting
University of Wisconsin Carbone Cancer Center- University Hospital Madison Wisconsin 53792 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 107 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06982521, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 7, 2026 · Synced May 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06982521 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →