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RECRUITING
NCT06982521
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

RLY-2608

400 mg orally BID administered daily on a 28-day treatment cycle

DRUG

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

DRUG

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