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NCT06982521 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
A Phase 3 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Relay Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT06982521: Recruiting Phase 3 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Relay Therapeutics.
NCT06982521 is a Phase 3 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by Relay Therapeutics. The registered enrollment target is 540 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06982521, a Phase 3 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Relay Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Capivasertib
- DRUG RLY-2608
Study Locations (20)
California
- Beverly Hills Cancer Center - Beverly Hills
- Cedars-Sinai Medical Center - Beverly Hills
- City of Hope - Duarte
- Stanford University School of Medicine - Palo Alto
- University of California Davis - Sacramento
- University of California San Diego - San Diego
- University of California San Francisco - San Francisco
Florida
- Florida Cancer Specialists - Fort Myers
- Cancer Care Centers of Brevard - Palm Bay
Illinois
- Rush Medical College - Chicago
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago
Kansas
- University of Kansas Medical Center - Westwood
- Cancer Center of Kansas - Wichita
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Colorado
- Rocky Mountain Cancer Centers - Longmont
Connecticut
- Yale Cancer Center - New Haven
Delaware
- Medical Oncology Hematology Consultants - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 3 |
What NCT06982521 shows while recruiting
NCT06982521 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (81% lower).
The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fulvestrant is the first listed.
NCT06982521 names 20 study sites across 11 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06982521 about?
NCT06982521 is a clinical study titled "Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer". 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 ...
What is the current status of trial NCT06982521?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2025-08-26. Estimated completion is 2031-12-31.
What conditions does trial NCT06982521 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, HER2-Negative Breast Cancer, Advanced Breast Cancer, Hormone Receptor Positive Tumor.
What interventions are being tested in trial NCT06982521?
The interventions under investigation include: Fulvestrant (DRUG), Capivasertib (DRUG), RLY-2608 (DRUG).
Who is sponsoring clinical trial NCT06982521?
This trial is sponsored by Relay Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06982521 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06982521's enrollment target sits among peer trials
540 185th of 1224 higher than 1,040 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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