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RECRUITING Phase 3 ClinicalTrials.gov

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. • ClinicalTrials.gov ID: NCT06982521

Registry updated: 2026-10-05
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Description

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.

Interventions

  • Zovegalisib (Drug)
    400 mg orally BID administered daily on a 28-day treatment cycle
  • Capivasertib (Drug)
    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 (Drug)
    500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)

Eligibility criteria

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: 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. Only 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: * Prior treatment with any of the following: 1. CDK2 inhibitors. Prior treatment with other investigational CDK inhibitors could be permitted upon discussion and approval from the Sponsor 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 (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

Conditions

PIK3CA Mutation HER2- Negative Breast Cancer Hormone Receptor Positive Tumor Breast Cancer Metastatic Breast Cancer Advanced Breast Cancer

Locations

  • 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
  • Organización Médica de Investigación (OMI) — Buenos Aires, Argentina
  • Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
  • Centro Medico Dr. Doreski- Fundacion Respirar — Buenos Aires, Argentina
  • Instituto de Investigaciones Clinicas de Cordoba — Córdoba, Argentina
  • Breast clinica de la mama — La Plata, Argentina
  • Hospital Provincial del Centenario — Rosario, Argentina
  • Instituto de Oncología de Rosario — Rosario, Argentina
  • Centro de Investigaciones Clinicas. Clinica Viedma S.A. — Viedma, Argentina
  • St. Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
  • Lake Macquarie Hospital — Gateshead, New South Wales, Australia
  • Mater Hospital Sydney — North Sydney, New South Wales, Australia
  • Sydney Adventist Hospital — Wahroonga, New South Wales, Australia
  • Monash Health — Clayton, Victoria, 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
  • Medical University of Graz — Graz, Austria
  • Ordensklinikum Linz GmbH — Linz, Austria
  • LKH Feldkirch, Interne E am LKH Rankweil — Rankweil, Austria
  • Universitair Ziekenhuis Antwerpen — Antwerp, Belgium
  • Institut Jules Bordet — Brussels, Belgium
  • Cliniques Universitaires Saint-Luc — Brussels, Belgium
  • Ghent University Hospital — Ghent, Belgium
  • Universitair Ziekenhuis Brussel — Jette, Belgium
  • Universitair Ziekenhuis Leuven — Leuven, Belgium
  • Centre Hospitalier de l'Ardenne — Libramont, Belgium
  • Clinique CHC Mont Legia — Liège, Belgium
  • CHU-UCL Namur, Site Sainte-Elisabeth — Namur, Belgium
  • Vitaz — Sint-Niklaas, Belgium
  • CHR de Verviers site Tourelle — Verviers, Belgium
  • CEMEC CTO (CPAM - Centro de Pesquisas da Amazônia) — Belém, Brazil
  • Oncolinicas do Brasil Serviços Médicos S.A (Oncocentro) — Belo Horizonte, Brazil
  • Instituto do Câncer do Ceará — Fortaleza, Brazil
  • Hospital de Cancer Araujo Jorge/ Associacao de Combate ao Cancer em Goias — Goiânia, Brazil
  • Oncoclinicas Natal- Centro de Pesquisa Oncology Natal — Natal, Brazil
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Brazil
  • Hospital de Clinicas 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
  • Centro de Oncologia do ABC- CEON+ Unidade Sao Caetano do Sul — São Caetano do Sul, Brazil
  • Sociedade Beneficente de Senhora Hospital Sírio-Libanês — São Paulo, Brazil
  • Clinica Onco Star — São Paulo, Brazil
  • MHAT "Dr. Tota Venkova", AD — Gabrovo, Bulgaria
  • Acibadem City Clinic Tokuda University Hospital EAD — Sofia, 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
  • Saskatoon Cancer Centre — Saskatoon, Saskatchewan, Canada
  • Masarykuv onkologicky ustav — Brno, Czechia
  • Nemocnice Horovice — Hořovice, Czechia
  • University Hospital Hradec Kralove — Hradec Králové, Czechia
  • Nemocnice AGEL Novy Jicin a.s. — Nový Jičín, Czechia
  • Fakultni Nemocnice Olomouc — Olomouc, Czechia
  • Vseobecna Fakultni nemocnice v Praze — Prague, Czechia
  • Fakultni Nemocnice v Motole — Prague, 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
  • Hopital Avicenne — Bobigny, France
  • Institut Bergonie — Bordeaux, France
  • Centre François Baclesse — Caen, France
  • Centre Leon Berard — Lyon, France
  • Hôpital Privé Jean Mermoz — Lyon, France
  • Hôpital de la Timone — Marseille, France
  • Centre de Cancérologie du Grand Montpellier — Montpellier, France
  • Centre Antoine Lacassagne — Nice, France
  • Institut Curie — Paris, France
  • Hôpital Saint Louis - SENOPOLE — Paris, France
  • Hôpital Privé des Côtes d'Armor — Plérin, France
  • Institut de Cancerologie de l'Ouest ICO — Saint-Herblain, France
  • Hopital du Leman — Thonon-les-Bains, France
  • Institut Claudius Regaud — Toulouse, France
  • Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France
  • UNEOS - Hopital Robert Schuman — Vantoux, France
  • Institut Gustave Roussy — Villejuif, France
  • MVZ Klinikum Aschaffenburg — Aschaffenburg, Germany
  • Marienhospital Bottrop gGmbH — Bottrop, Germany
  • Universitätsklinikum Carl Gustav Carus TU Dresden — Dresden, Germany
  • Studienzentrale für das MVZ Eggenfelden GbR — Eggenfelden, Germany
  • Universitätsklinikum Erlange — Erlangen, Germany
  • Universitaetsklinikum Freiburg — Freiburg im Breisgau, Germany
  • Praxis fuer Interdisziplinaere Onkologie und Haematologie — Freiburg im Breisgau, Germany
  • Helios Klinikum Krefeld — Krefeld, Germany
  • Universitaetsmedizin Mannheim — Mannheim, Germany
  • TUM Universitätsklinikum — München, Germany
  • Anticancer Hospital "Agios Savvas" — Athens, Greece
  • 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
  • Gleneagles Hospital Hong Kong — Hong Kong, Hong Kong
  • Hong Kong United Oncology Centre — Hong Kong, Hong Kong
  • Queen Mary Hospital — Hong Kong, Hong Kong
  • Beaumont Hospital — Dublin, Ireland
  • 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
  • Istituto Europeo di Oncologia — Milan, Italy
  • Hospital San Giuseppe — Milan, Italy
  • Humanitas Istituto Clinico Catanese — Misterbianco, Italy
  • Irccs Iov — Padova, Italy
  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone — Palermo, Italy
  • IRCCS Policlinico San Matteo — Pavia, Italy
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy
  • Azienda Ospedaliera S.Maria - Terni — Terni, Italy
  • Maastricht University Medical Center — Maastricht, Netherlands
  • Radboud UMC — Nijmegen, Netherlands
  • Zuyderland Medisch Centrum - Heerlen — Sittard, Netherlands
  • Haga Ziekenhuis — The Hague, Netherlands
  • Przychodnia Lekarska KOMED — Konin, Poland
  • Pratia MCM Krakow — Krakow, Poland
  • Centrum Onkologii Ziemi Lubelskiej — Lublin, Poland
  • Uniwersytecki Szpital Kliniczny W Poznaniu — Poznan, Poland
  • Mruk-Med Sp. z o.o — Rzeszów, Poland
  • Centrum Medyczne Medyk — Rzeszów, Poland
  • Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - w Warszawie - Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej — Warsaw, Poland
  • Hospital da Luz — Lisbon, Portugal
  • Hospital CUF Descobertas — Lisbon, Portugal
  • Unidade Local de Saude de Loures Odivelas E.P.E. Hospital Beatriz Angelo — Loures, Portugal
  • Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano — Matosinhos Municipality, Portugal
  • Oncolab SRL — Craiova, Romania
  • Victoria Hospital SRL — Iași, Romania
  • Asociatia Oncohelp — Timișoara, Romania
  • 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
  • ICO Badalona - Hospital Universitari Germans Trias i Pujol — Badalona, Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Spain
  • Hospital Clinic de Barcelona — Barcelona, Spain
  • Hospital General de Catalunya — Barcelona, Spain
  • Institut Català d'Oncologia de L'Hospìtalet (ICO l'Hospitalet) — Barcelona, Spain
  • Hospital Provincial de Castellon — Castellon, 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 Universitaro de Jaen — Jaén, 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 Universitario La Paz — Madrid, Spain
  • Hospital General Universitario Morales Meseguer — Murcia, Spain
  • Hospital Universitario Son Espases — Palma de Mallorca, Spain
  • Hospital Universitario de Canarias — San Cristóbal de La Laguna, Spain
  • Hospital Universitario Virgen de Macarena — Seville, Spain
  • Instituto Valenciano de Oncologia (IVO) — Valencia, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
  • Tumor Zentrum Aarau — Aarau, Switzerland
  • University Hospital of Basel — Basel, Switzerland
  • 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
  • Dicle University Hospital — Sur, Turkey (Türkiye)
  • Royal United Hospitals Bath NHS Foundation Trust — Bath, United Kingdom
  • Velindre University NHS Trust — Cardiff, United Kingdom
  • St. Bartholomew's Hospital — London, United Kingdom
  • University College London Hospitals NHS Foundation Trust — London, United Kingdom
  • Guy's and St. Thomas' NHS Foundation Trust — London, United Kingdom
  • Sarah Cannon Research Institute UK — London, United Kingdom
  • The Christie NHS Foundation Trust — Manchester, United Kingdom
  • Nottingham University Hospital NHS Trust — Nottingham, United Kingdom
  • Great Western Hospital NHS Foundation Trust — Swindon, United Kingdom
  • Royal Cornwall Hospital — Truro, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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