Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
Recruiting · NCT06982521 · Interventional (participants receive a specific treatment) · Lead sponsor: Relay Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patient has ECOG performance status of 0-1
- 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 2 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:
- 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
- Only 1 prior line of CDK4/6 inhibitor therapy in one of the following settings:
- CDK4/6 inhibitor + ET in the ABC setting
- 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
- 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
- Prior treatment with any of the following:
- CDK2 inhibitors. Prior treatment with other investigational CDK inhibitors could be permitted upon discussion and approval from the Sponsor
- PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3/AKT/mTOR pathway
- Immunotherapy
- Antibody drug conjugates
- Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg/dL (7.8 mmol/L), 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, zovegalisib, 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
Where it is running
60 locations listed across 28 US states.
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Beverly Hills Cancer Center - Beverly Hills, California, United States
- City of Hope National Medical Center - Duarte, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Stanford Women's Cancer Center - Palo Alto, California, United States
- University of California, Davis Comprehensive Cancer Center - Sacramento, California, United States
- University of California San Diego Moores Cancer Center - San Diego, California, United States
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center - San Francisco, California, United States
- Kaiser Permanente Medical Center - Vallejo, California, United States
- Rocky Mountain Cancer Centers, LLP - Longmont, Colorado, United States
- Yale-New Haven Hospital-Yale Cancer Center - New Haven, Connecticut, United States
- Medical Oncology Hematology Consultants, P.A. - Newark, Delaware, United States
- Georgetown University Medical Center - Washington D.C., District of Columbia, United States
- AdventHealth - Altamonte Springs, Florida, United States
- Florida Cancer Specialists-South - Fort Myers, Florida, United States
- Cancer Care Centers of Brevard, Inc - Palm Bay, Florida, United States
- Atlanta Cancer Care - Northside Hospital - Atlanta, Georgia, United States
- Rush University Medical Center - Chicago, Illinois, United States
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago, Illinois, United States
- Community Health Network, Inc - Indianapolis, Indiana, United States
- University of Kansas Cancer Center - Westwood, Kansas, United States
- Cancer Center of Kansas - Wichita, Kansas, United States
- Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins - Baltimore, Maryland, United States
- Tufts Medical Center - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Profound Research LLC - Royal Oak, Michigan, United States
- Minnesota Oncology Hematology, P.A. - Minneapolis, Minnesota, United States
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- Washington University School of Medicine- Siteman Cancer Center - St Louis, Missouri, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Renown Health Medical Oncology - Reno, Nevada, United States
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack, New Jersey, United States
- Rutgers Cancer Institute - New Brunswick, New Jersey, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Columbia University Irving Medical Center - New York, New York, United States
- Memorial Sloan-Kettering Cancer Center - New York, New York, United States
- Oregon Health & Science University, Knight Cancer Institute - Portland, Oregon, United States
- Avera Cancer Institute - Sioux Falls, South Dakota, United States
- Tennessee Cancer Specialists - Knoxville, Tennessee, United States
- Tennessee Oncology, PLLC - Nashville, Tennessee, United States
- Texas Oncology Central/South - Austin, Texas, United States
- Texas Oncology DFW - Dallas, Texas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- Houston Methodist Hospital Cancer Center - Houston, Texas, United States
- The University of Texas M.D. Anderson Cancer Center - Houston, Texas, United States
- Baylor Scott and White Medical Center - Temple, Texas, United States
- Huntsman Cancer Institute, University of Utah - Salt Lake City, Utah, United States
- Virginia Cancer Specialists, PC - Fairfax, Virginia, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- University of Wisconsin Carbone Cancer Center- University Hospital - Madison, Wisconsin, United States
- Aalborg University Hospital - Aalborg, Denmark
- Tumor Zentrum Aarau - Aarau, Switzerland
- Azienda Ospedaliero Universitaria delle Marche - Ancona, Italy
- L'Institut de Cancérologie de l'Ouest (ICO) - Angers - Angers, France
- Universitair Ziekenhuis Antwerpen - Antwerp, Belgium
- MVZ Klinikum Aschaffenburg - Aschaffenburg, Germany
- Anticancer Hospital "Agios Savvas" - Athens, Greece
- University General Hospital of Athens "Attikon" - Athens, Greece
Showing 60 of 231 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →