Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
NCT ID: NCT06982521
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
540 participants
INTERVENTIONAL
2025-08-26
2031-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RLY-2608 + fulvestrant
RLY-2608 + fulvestrant combination for participants with HR+/HER2- advanced breast cancer
RLY-2608
400 mg orally BID administered daily on a 28-day treatment cycle
Fulvestrant
500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)
capivasertib + fulvestrant
capivasertib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer
Capivasertib
400mg orally BID administered on an intermittent weekly dosing schedule. Patients will dose on Days 1 through 4 each week of a 28-day treatment cycle
Fulvestrant
500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RLY-2608
400 mg orally BID administered daily on a 28-day treatment cycle
Capivasertib
400mg orally BID administered on an intermittent weekly dosing schedule. Patients will dose on Days 1 through 4 each week of a 28-day treatment cycle
Fulvestrant
500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* One or more known primary oncogenic PIK3CA mutation(s)
* Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have commenced treatment with a GnRH agonist at least 4 weeks prior to randomization and must be willing to continue on it for the duration of the study.
* Histologically or cytologically confirmed diagnosis of HR+/HER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent
* Measurable disease per RECIST v1.1 or evaluable bone-only disease.
* Must have radiological evidence of progression on or after previous treatment for HR+/HER2- ABC with:
1. At least 1 and no more than 2 lines of endocrine therapy (ET) in the (neo)adjuvant setting with recurrence on or within 12 months of completion or in the ABC setting
2. 1 prior line of CDK4/6 inhibitor therapy in one of the following settings:
1. CDK4/6 inhibitor + ET in the ABC setting
2. CDK4/6 inhibitor therapy in the adjuvant setting if progression occurred during or within 12 months of completion of adjuvant CDK4/6 inhibitor with ET
3. Patients who progressed during or within 12 months of completion of adjuvant CDK4/6 inhibitor and after receiving CDK4/6 inhibitor therapy in the advanced setting are considered to have had \>1 prior line of CDK4/6 inhibitor and are not eligible
Exclusion Criteria
1. CDK2 or selective CDK4 inhibitors or any investigational therapies targeting cyclin dependent kinases
2. PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3/AKT/mTOR pathway
3. Immunotherapy
4. Antibody drug conjugates
* Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg/dL, or glycosylated hemoglobin (HbA1c) ≥7.0% (≥ 53 mmol/mol).
* Clinically significant, uncontrolled cardiovascular disease
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
* Known active uncontrolled or symptomatic CNS metastases associated with progressive neurological symptoms or requiring ongoing corticosteroids or anticonvulsants for symptomatic control
* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
* History of hypersensitivity to fulvestrant or drugs in a similar class as fulvestrant, RLY-2608, or capivasertib, including their excipients
* Known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression resulting in oncogenic pathway activation downstream of PI3K
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Relay Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beverly Hills Cancer Center
Beverly Hills, California, United States
Cedars-Sinai Medical Center
Beverly Hills, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
University of California San Francisco
San Francisco, California, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Cancer Care Centers of Brevard
Palm Bay, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Community Health Network
Indianapolis, Indiana, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Profound Research LLC
Royal Oak, Michigan, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
NYU Langone Cancer Center
New York, New York, United States
Columbia University Herbert Irving Medical Center
New York, New York, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology Central/South
Austin, Texas, United States
Texas Oncology DFW
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Center, University of Utah
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Ballarat Oncology & Haematology Service
Wendouree, Victoria, Australia
CHU-UCL Namur, Site Sainte-Elisabeth
Namur, , Belgium
Vitaz, Campus Sint-Niklaas
Sint-Niklaas, , Belgium
CEON+ Pesquisas
São Caetano do Sul, São Paulo, Brazil
Aalborg University Hospital
Aalborg, , Denmark
Sygehus Sønderjylland
Sønderborg, , Denmark
Hospital Clinic de Barcelona
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RLY-2608-102
Identifier Type: -
Identifier Source: org_study_id