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Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
NCT06982521 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06982521
The ClinicalTrials.gov registry entry for NCT06982521 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Relay Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06982521 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Advanced Breast Cancer, Hormone Receptor Positive Tumor, PIK3CA Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06982521?
The interventions under investigation include: Fulvestrant (DRUG), Capivasertib (DRUG), RLY-2608 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06982521?
This trial is sponsored by Relay Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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