Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (NCT06982521)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center โ Gilbert, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (222 Sites)
Showing the first 25 of 222 sites.
- Banner MD Anderson Cancer Center โ Gilbert, Arizona
- Beverly Hills Cancer Center โ Beverly Hills, California
- City of Hope National Medical Center โ Duarte, California
- Cedars-Sinai Medical Center โ Los Angeles, California
- Stanford Women's Cancer Center โ Palo Alto, California
- University of California, Davis Comprehensive Cancer Center โ Sacramento, California
- University of California San Diego Moores Cancer Center โ San Diego, California
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center โ San Francisco, California
- Kaiser Permanente Medical Center โ Vallejo, California
- Rocky Mountain Cancer Centers, LLP โ Longmont, Colorado
- Yale-New Haven Hospital-Yale Cancer Center โ New Haven, Connecticut
- Medical Oncology Hematology Consultants, P.A. โ Newark, Delaware
- Georgetown University Medical Center โ Washington D.C., District of Columbia
- AdventHealth โ Altamonte Springs, Florida
- Florida Cancer Specialists-South โ Fort Myers, Florida
- Cancer Care Centers of Brevard, Inc โ Palm Bay, Florida
- Atlanta Cancer Care - Northside Hospital โ Atlanta, Georgia
- Rush University Medical Center โ Chicago, Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University โ Chicago, Illinois
- Community Health Network, Inc โ Indianapolis, Indiana
- University of Kansas Cancer Center โ Westwood, Kansas
- Cancer Center of Kansas โ Wichita, Kansas
- Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins โ Baltimore, Maryland
- Tufts Medical Center โ Boston, Massachusetts
- Dana Farber Cancer Institute โ Boston, Massachusetts
๐ Contact the Study Coordinator
Phone: (617) 322-0731
Email: ClinicalTrials@relaytx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in PIK3CA Mutation
Explore by condition: All PIK3CA Mutation clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.