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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
2026-05-08
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 (158)
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
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
Centro Medico Dr. Doreski- Fundacion Respirar
Buenos Aires, Argentina
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
Bayside Health (Alfred)
Melbourne, Victoria, Australia
Sunshine Hospital
Saint Albans, Victoria, Australia
Ballarat Oncology & Haematology Clinical Research Fund
Wendouree, Victoria, Australia
Mater Hospital Sydney
North Sydney, Australia
Medical University of Graz
Graz, Austria
Ordensklinikum Linz GmbH
Linz, Austria
LKH Feldkirch, Interne E am LKH Rankweil
Rankweil, Austria
Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Centre Hospitalier de l'Ardenne
Libramont, Belgium
CHU-UCL Namur, Site Sainte-Elisabeth
Namur, Belgium
Vitaz
Sint-Niklaas, Belgium
CHR de Verviers site Tourelle
Verviers, Belgium
Centro de Oncologia do ABC- CEON+ Unidade Sao Caetano do Sul
São Caetano do Sul, São Paulo, Brazil
Oncolinicas do Brasil Serviços Médicos S.A (Oncocentro)
Belo Horizonte, Brazil
Instituto do Câncer do Ceará
Fortaleza, Brazil
Oncoclinicas Natal- Centro de Pesquisa Oncology Natal
Natal, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Centro Gaúcho Integrado - Hospital Mae de Deus
Porto Alegre, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia/ Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, Brazil
Instituto de Educação Pesquisa e Gestão em Saúde
Rio de Janeiro, Brazil
Nucleo de Oncologia da Bahia S.A.
Salvador, Brazil
MHAT "Dr. Tota Venkova", AD
Gabrovo, Bulgaria
William Osler Health System- Brampton Civic Hospital
Brampton, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Masarykuv onkologicky ustav
Brno, Czechia
University Hospital Hradec Kralove
Hradec Králové, Czechia
Aalborg University Hospital
Aalborg, Denmark
Zealand University Hospital
Næstved, Denmark
Sønderborg Sygehus
Sønderborg, Denmark
L'Institut de Cancérologie de l'Ouest (ICO) - Angers
Angers, France
CHU Besancon
Besançon, France
Centre François Baclesse
Caen, France
Centre Leon Berard
Lyon, France
Hôpital Privé Jean Mermoz
Lyon, France
Centre de Cancérologie du Grand Montpellier
Montpellier, France
Hopital du Leman
Thonon-les-Bains, France
Institut Claudius Regaud
Toulouse, France
Marienhospital Bottrop gGmbH
Bottrop, Germany
Studienzentrale für das MVZ Eggenfelden GbR
Eggenfelden, Germany
Praxis fuer Interdisziplinaere Onkologie und Haematologie
Freiburg im Breisgau, Germany
Universitaetsmedizin Mannheim
Mannheim, Germany
University General Hospital of Athens "Attikon"
Athens, Greece
Iaso Hospital
Athens, Greece
General University Hospital of Crete
Heraklion, Greece
University Hospital of Larissa
Larissa, Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, Greece
Hong Kong United Oncology Centre
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Italy
IRCCS Candiolo
Candiolo, Italy
AOU Ferrara, Arcispedale Sant'Anna
Cona, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Azienda USl Toscana Nord Ovest SC Oncologia Medica Ospedale Civile Livorno
Livorno, Italy
IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori"
Meldola, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Hospital San Giuseppe
Milan, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Maastricht University Medical Center
Maastricht, Netherlands
Radboud UMC
Nijmegen, Netherlands
Zuyderland Medisch Centrum - Heerlen
Sittard, Netherlands
Haga Ziekenhuis
The Hague, Netherlands
Pratia MCM Krakow
Krakow, Poland
Mruk-Med Sp. z o.o
Rzeszów, Poland
Hospital da Luz
Lisbon, Portugal
Unidade Local de Saude de Loures Odivelas E.P.E. Hospital Beatriz Angelo
Loures, Portugal
Raffles Hospital
Singapore, Singapore
Curie Oncology (Farrer)
Singapore, Singapore
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, 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 Virgen de la Arrixaca
El Palmar, Spain
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona, 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
Instituto Valenciano de Oncologia (IVO)
Valencia, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei 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, Taiwan