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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
Sponsor: Relay Therapeutics, Inc.
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.
Official title: A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2025-08-26
Completion Date
2031-12-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (120)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Cedars-Sinai Medical Center
Beverly Hills, California, United States
City of Hope
Duarte, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
University of California Davis
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Kaiser Permanente - Vallejo
Vallejo, 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
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Cancer Care Centers of Brevard
Palm Bay, Florida, United States
Rush Medical College
Chicago, Illinois, 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
Tufts Medical Center
Boston, Massachusetts, 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
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Renown Regional Medical Center
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
NYU Langone Cancer Center
New York, New York, United States
Mount Sinai
New York, New York, United States
Columbia University Herbert Irving Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, 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
Houston Methodist Hospital
Houston, Texas, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Baylor Scott and White Research Institute
Temple, 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
University of Wisconsin
Madison, Wisconsin, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Barwon Health
Geelong, Victoria, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sunshine Hospital
Saint Albans, Victoria, Australia
Ballarat Oncology & Haematology Service
Wendouree, Victoria, Australia
Medical University of Graz
Graz, Austria
Ordensklinikum Linz GmbH
Linz, Austria
LKH Feldkirch, Interne E am LKH Rankweil
Rankweil, Austria
Centre Hospitalier de l'Ardenne
Libramont, Belgium
CHU-UCL Namur, Site Sainte-Elisabeth
Namur, Belgium
Vitaz, Campus Sint-Niklaas
Sint-Niklaas, Belgium
CHR de Verviers site Tourelle
Verviers, Belgium
CEON+ Pesquisas
São Caetano do Sul, São Paulo, Brazil
Centro de Pesquisa Oncoclinica Natal Oncoclinicas
Natal, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, Brazil
Centro de Pesquisa Clínica da Associação Hospitalar Moinhos de Vento
Porto Alegre, Brazil
Centro de Pesquisa em Oncologia - PUCRS
Porto Alegre, Brazil
Oncoclinicas Rio de Janeiro
Rio de Janeiro, Brazil
Instituto de Educação Pesquisa e Gestão em Saúde
Rio de Janeiro, Brazil
NOB (Nucleo de Oncologia da Bahia)
Salvador, Brazil
William Osler Health System- Brampton Civic Hospital
Brampton, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Masarykuv onkologicky ustav
Brno, Czechia
Aalborg University Hospital
Aalborg, Denmark
Zealand University Hospital
Næstved, Denmark
Sygehus Sønderjylland
Sønderborg, Denmark
Centre Leon Berard
Lyon, France
Marienhospital Bottrop gGmbH
Bottrop, Germany
Studienzentrale für das MVZ Eggenfelden GbR
Eggenfelden, Germany
Praxis fuer Interdisziplinaere Onkologie und Haematologie
Freiburg im Breisgau, Germany
Iaso Hospital
Athens, Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, Greece
Hong Kong United Oncology Centre
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
IRCCS Candiolo
Candiolo, Italy
AOU Ferrara, Arcispedale Sant'Anna
Cona, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Maastricht University Medical Center
Maastricht, Netherlands
Radboud UMC
Nijmegen, Netherlands
Haga Ziekenhuis
The Hague, Netherlands
Pratia MCM Krakow
Krakow, Poland
Curie Oncology
Singapore, Singapore
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University, Seoul St. Mary's Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital San Pedro de Alcantara
Cáceres, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Spain
Hospital Beata Maria Ana/IOB Madrid
Madrid, Spain
Clinica Universidad de Navarra
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan