Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (81% lower). The listed sponsor is Relay Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
-
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
RECRUITING · Phase 3
-
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
RECRUITING · Phase 3
-
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
RECRUITING · Phase 3
-
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
RECRUITING · Phase 3
-
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
RECRUITING · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.