Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
NCT06982521
This study is recruiting at 52 US sites in 28 states, according to its ClinicalTrials.gov record last updated .
Summary
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + 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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- PIK3CA Mutation
- HER2- Negative Breast Cancer
- Hormone Receptor Positive Tumor
- Breast Cancer
- Metastatic Breast Cancer
- Advanced Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Relay Therapeutics, Inc.
- Last updated on ClinicalTrials.gov
- October 5, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- Banner MD Anderson Cancer Center · Gilbert, AZ
California · 8
- Beverly Hills Cancer Center · Beverly Hills, CA
- City of Hope National Medical Center · Duarte, CA
- Cedars-Sinai Medical Center · Los Angeles, CA
- Stanford Women's Cancer Center · Palo Alto, CA
- University of California, Davis Comprehensive Cancer Center · Sacramento, CA
- University of California San Diego Moores Cancer Center · San Diego, CA
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center · San Francisco, CA
- Kaiser Permanente Medical Center · Vallejo, CA
Colorado · 1
- Rocky Mountain Cancer Centers, LLP · Longmont, CO
Connecticut · 1
- Yale-New Haven Hospital-Yale Cancer Center · New Haven, CT
Delaware · 1
- Medical Oncology Hematology Consultants, P.A. · Newark, DE
District of Columbia · 1
- Georgetown University Medical Center · Washington D.C., DC
Florida · 3
- AdventHealth · Altamonte Springs, FL
- Florida Cancer Specialists-South · Fort Myers, FL
- Cancer Care Centers of Brevard, Inc · Palm Bay, FL
Georgia · 1
- Atlanta Cancer Care - Northside Hospital · Atlanta, GA
Illinois · 2
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University · Chicago, IL
- Rush University Medical Center · Chicago, IL
Indiana · 1
- Community Health Network, Inc · Indianapolis, IN
Kansas · 2
- University of Kansas Cancer Center · Westwood, KS
- Cancer Center of Kansas · Wichita, KS
Maryland · 1
- Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins · Baltimore, MD
Massachusetts · 2
- Dana Farber Cancer Institute · Boston, MA
- Tufts Medical Center · Boston, MA
Michigan · 2
- University of Michigan · Ann Arbor, MI
- Profound Research LLC · Royal Oak, MI
Minnesota · 1
- Minnesota Oncology Hematology, P.A. · Minneapolis, MN
Mississippi · 1
- University of Mississippi Medical Center · Jackson, MS
Missouri · 1
- Washington University School of Medicine- Siteman Cancer Center · St Louis, MO
Nebraska · 1
- Nebraska Cancer Specialists · Omaha, NE
Nevada · 1
- Renown Health Medical Oncology · Reno, NV
New Jersey · 2
- John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, NJ
- Rutgers Cancer Institute · New Brunswick, NJ
New York · 4
- Columbia University Irving Medical Center · New York, NY
- Icahn School of Medicine at Mount Sinai · New York, NY
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health · New York, NY
- Memorial Sloan-Kettering Cancer Center · New York, NY
Oregon · 1
- Oregon Health & Science University, Knight Cancer Institute · Portland, OR
South Dakota · 1
- Avera Cancer Institute · Sioux Falls, SD
Tennessee · 2
- Tennessee Cancer Specialists · Knoxville, TN
- Tennessee Oncology, PLLC · Nashville, TN
Texas · 6
- Texas Oncology Central/South · Austin, TX
- Texas Oncology DFW · Dallas, TX
- University of Texas Southwestern Medical Center · Dallas, TX
- Houston Methodist Hospital Cancer Center · Houston, TX
- The University of Texas M.D. Anderson Cancer Center · Houston, TX
- Baylor Scott and White Medical Center · Temple, TX
Utah · 1
- Huntsman Cancer Institute, University of Utah · Salt Lake City, UT
Virginia · 2
- Virginia Cancer Specialists, PC · Fairfax, VA
- Virginia Oncology Associates · Norfolk, VA
Wisconsin · 1
- University of Wisconsin Carbone Cancer Center- University Hospital · Madison, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.