AzTrials
AzTrials

PIK3CA MutationPhase 3ReDiscover-2NCT06982521

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

A Phase 3 study testing Zovegalisib, Capivasertib and Fulvestrant in people with PIK3CA Mutation and HER2- Negative Breast Cancer, run by Relay Therapeutics, Inc. at 254 sites in 27 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zovegalisib, Capivasertib and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
254 sitesin 27 countries
Study dates
26 Aug 2025to 31 Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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).
Show all 12Show fewer
  • 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

Trial locations and contacts

254 sites in 27 countries. Contact the study team or a site near you to ask about taking part.

Relay Therapeutics, Inc contact

617-322-0731

ClinicalTrials@relaytx.com

254 sites in 27 countries

United States52 sites, 52 recruiting

  • AdventHealth

    Altamonte Springs, Florida, 32701

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • Atlanta Cancer Care - Northside Hospital

    Atlanta, Georgia, 30342

    Recruiting

  • Texas Oncology Central/South

    Austin, Texas, 78731

    Recruiting

  • Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins

    Baltimore, Maryland, 21287

    Recruiting

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60607

    Recruiting

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

    Recruiting

  • Texas Oncology DFW

    Dallas, Texas, 75246

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

    Recruiting

  • Florida Cancer Specialists-South

    Fort Myers, Florida, 33901

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Houston Methodist Hospital Cancer Center

    Houston, Texas, 77030

    Recruiting

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Community Health Network, Inc

    Indianapolis, Indiana, 46250

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39213

    Recruiting

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

    Recruiting

  • Rocky Mountain Cancer Centers, LLP

    Longmont, Colorado, 80504

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • University of Wisconsin Carbone Cancer Center- University Hospital

    Madison, Wisconsin, 53792

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

    Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

    Recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901

    Recruiting

  • Yale-New Haven Hospital-Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Medical Oncology Hematology Consultants, P.A.

    Newark, Delaware, 19713

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Recruiting

  • Cancer Care Centers of Brevard, Inc

    Palm Bay, Florida, 32909

    Recruiting

  • Stanford Women's Cancer Center

    Palo Alto, California, 94304

    Recruiting

  • Oregon Health & Science University, Knight Cancer Institute

    Portland, Oregon, 97210

    Recruiting

  • Renown Health Medical Oncology

    Reno, Nevada, 89502

    Recruiting

  • Profound Research LLC

    Royal Oak, Michigan, 48073

    Recruiting

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Recruiting

  • University of California San Diego Moores Cancer Center

    San Diego, California, 92037

    Recruiting

  • University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Washington University School of Medicine- Siteman Cancer Center

    St Louis, Missouri, 63108

    Recruiting

  • Baylor Scott and White Medical Center

    Temple, Texas, 76508

    Recruiting

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

    Recruiting

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Recruiting

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

    Recruiting

Other trials in United States

Spain25 sites, 25 recruiting

  • Hospital Universitario de Badajoz

    Badajoz, 06006

    Recruiting

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital General de Catalunya

    Barcelona, 08195

    Recruiting

  • Institut Català d'Oncologia de L'Hospìtalet (ICO l'Hospitalet)

    Barcelona, 08908

    Recruiting

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

    Recruiting

  • Hospital Provincial de Castellon

    Castellon, 12002

    Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120

    Recruiting

  • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

    Recruiting

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

    Recruiting

  • Hospital Universitaro de Jaen

    Jaén, 23007

    Recruiting

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

    Recruiting

  • Hospital Beata Maria Ana/IOB Madrid

    Madrid, 28007

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Clinica Universidad de Navarra

    Madrid, 28027

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

    Recruiting

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120

    Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

    Recruiting

  • Hospital Universitario Virgen de Macarena

    Seville, 41009

    Recruiting

  • Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

France20 sites, 20 recruiting

  • L'Institut de Cancérologie de l'Ouest (ICO) - Angers

    Angers, 49055

    Recruiting

  • CHU Besancon

    Besançon, 25030

    Recruiting

  • Hopital Avicenne

    Bobigny, 93000

    Recruiting

  • Institut Bergonie

    Bordeaux, 33076

    Recruiting

  • Centre François Baclesse

    Caen, 14000

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21000

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

    Recruiting

  • Hôpital de la Timone

    Marseille, 13005

    Recruiting

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, 34070

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06100

    Recruiting

  • Institut Curie

    Paris, 75005

    Recruiting

  • Hôpital Saint Louis - SENOPOLE

    Paris, 75010

    Recruiting

  • Hôpital Privé des Côtes d'Armor

    Plérin, 22190

    Recruiting

  • Institut de Cancerologie de l'Ouest ICO

    Saint-Herblain, 44800

    Recruiting

  • Hopital du Leman

    Thonon-les-Bains, 74200

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31300

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Recruiting

  • UNEOS - Hopital Robert Schuman

    Vantoux, 57000

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Brazil16 sites, 16 recruiting

  • CEMEC CTO (CPAM - Centro de Pesquisas da Amazônia)

    Belém, 66073-005

    Recruiting

  • Oncolinicas do Brasil Serviços Médicos S.A (Oncocentro)

    Belo Horizonte, 30360-680

    Recruiting

  • Instituto do Câncer do Ceará

    Fortaleza, 60430-235

    Recruiting

  • Hospital de Cancer Araujo Jorge/ Associacao de Combate ao Cancer em Goias

    Goiânia, 74605-070

    Recruiting

  • Oncoclinicas Natal- Centro de Pesquisa Oncology Natal

    Natal, 59020-505

    Recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90020-090

    Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

    Recruiting

  • Centro Gaúcho Integrado - Hospital Mae de Deus

    Porto Alegre, 90110-270

    Recruiting

  • Associação Hospitalar Moinhos de Vento

    Porto Alegre, 90560-032

    Recruiting

  • Uniao Brasileira de Educacao e Assistencia/ Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

    Recruiting

  • Oncoclinicas Rio de Janeiro S.A.

    Rio de Janeiro, 22250-905

    Recruiting

  • Instituto de Educação Pesquisa e Gestão em Saúde

    Rio de Janeiro, 22775-001

    Recruiting

  • Nucleo de Oncologia da Bahia S.A.

    Salvador, 40170-110

    Recruiting

  • Centro de Oncologia do ABC- CEON+ Unidade Sao Caetano do Sul

    São Caetano do Sul, 09541-270

    Recruiting

  • Sociedade Beneficente de Senhora Hospital Sírio-Libanês

    São Paulo, 01308-050

    Recruiting

  • Clinica Onco Star

    São Paulo, 04543-000

    Recruiting

Other trials in Brazil

Italy16 sites, 16 recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, 60126

    Recruiting

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

    Recruiting

  • IRCCS Candiolo

    Candiolo, 10060

    Recruiting

  • AOU Ferrara, Arcispedale Sant'Anna

    Cona, 44124

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

    Recruiting

  • Azienda USl Toscana Nord Ovest SC Oncologia Medica Ospedale Civile Livorno

    Livorno, 57124

    Recruiting

  • IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori"

    Meldola, 47014

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Hospital San Giuseppe

    Milan, 50053

    Recruiting

  • Humanitas Istituto Clinico Catanese

    Misterbianco, 95045

    Recruiting

  • Irccs Iov

    Padova, 35128

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

    Recruiting

  • IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168

    Recruiting

  • Azienda Ospedaliera S.Maria - Terni

    Terni, 05100

    Recruiting

Other trials in Italy

Belgium11 sites, 11 recruiting

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650

    Recruiting

  • Institut Jules Bordet

    Brussels, 1070

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Recruiting

  • Ghent University Hospital

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Brussel

    Jette, 1090

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • Centre Hospitalier de l'Ardenne

    Libramont, 6800

    Recruiting

  • Clinique CHC Mont Legia

    Liège, 4000

    Recruiting

  • CHU-UCL Namur, Site Sainte-Elisabeth

    Namur, 5000

    Recruiting

  • Vitaz

    Sint-Niklaas, 9100

    Recruiting

  • CHR de Verviers site Tourelle

    Verviers, 4800

    Recruiting

Other trials in Belgium

Germany11 sites, 11 recruiting

  • Universitätsklinikum Aachen AÖR

    Aachen, 52074

    Recruiting

  • MVZ Klinikum Aschaffenburg

    Aschaffenburg, 63768

    Recruiting

  • Marienhospital Bottrop gGmbH

    Bottrop, 46236

    Recruiting

  • Universitätsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

    Recruiting

  • Studienzentrale für das MVZ Eggenfelden GbR

    Eggenfelden, 84307

    Recruiting

  • Universitätsklinikum Erlange

    Erlangen, 91054

    Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Recruiting

  • Praxis fuer Interdisziplinaere Onkologie und Haematologie

    Freiburg im Breisgau, 79110

    Recruiting

  • Helios Klinikum Krefeld

    Krefeld, 47805

    Recruiting

  • Universitaetsmedizin Mannheim

    Mannheim, 68167

    Recruiting

  • TUM Universitätsklinikum

    München, 81675

    Recruiting

Other trials in Germany

United Kingdom11 sites, 11 recruiting

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath, BA1 3NG

    Recruiting

  • Velindre University NHS Trust

    Cardiff, CF15 7QZ

    Recruiting

  • St. Bartholomew's Hospital

    London, EC1A 7BE

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

    Recruiting

  • Guy's and St. Thomas' NHS Foundation Trust

    London, SE1 7EH

    Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Recruiting

  • Nottingham University Hospital NHS Trust

    Nottingham, NG5 1PB

    Recruiting

  • Great Western Hospital NHS Foundation Trust

    Swindon, SN3 6BB

    Recruiting

  • Musgrove Park Hospital, Somerset NHS Foundation Trust

    Taunton, TA1 5DA

    Recruiting

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

    Recruiting

Other trials in United Kingdom

Australia10 sites, 10 recruiting

  • Monash Health

    Clayton, Victoria, 3168

    Recruiting

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

    Recruiting

  • Lake Macquarie Hospital

    Gateshead, New South Wales, 2290

    Recruiting

  • Barwon Health

    Geelong, Victoria, 3220

    Recruiting

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000

    Recruiting

  • Bayside Health (Alfred)

    Melbourne, Victoria, 3004

    Recruiting

  • Mater Hospital Sydney

    North Sydney, New South Wales, 2060

    Recruiting

  • Sunshine Hospital

    Saint Albans, Victoria, 3021

    Recruiting

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

    Recruiting

  • Ballarat Oncology & Haematology Clinical Research Fund

    Wendouree, Victoria, 3355

    Recruiting

Other trials in Australia

South Korea9 sites, 9 recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, 13496

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

  • Seoul National University Bundang Hospital

    Seoul, 13620

    Recruiting

Other trials in South Korea

Argentina8 sites, 8 recruiting

  • Organización Médica de Investigación (OMI)

    Buenos Aires, 1015

    Recruiting

  • Hospital Britanico de Buenos Aires

    Buenos Aires, 1280

    Recruiting

  • Centro Medico Dr. Doreski- Fundacion Respirar

    Buenos Aires, 1426

    Recruiting

  • Instituto de Investigaciones Clinicas de Cordoba

    Córdoba, 5000

    Recruiting

  • Breast clinica de la mama

    La Plata, 1900

    Recruiting

  • Hospital Provincial del Centenario

    Rosario, 2002

    Recruiting

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

    Recruiting

  • Centro de Investigaciones Clinicas. Clinica Viedma S.A.

    Viedma, R8500ACE

    Recruiting

Other trials in Argentina

Czechia7 sites, 7 recruiting

  • Masarykuv onkologicky ustav

    Brno, 656 53

    Recruiting

  • Nemocnice Horovice

    Hořovice, 268 01

    Recruiting

  • University Hospital Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín, 741 01

    Recruiting

  • Fakultni Nemocnice Olomouc

    Olomouc, 779 00

    Recruiting

  • Vseobecna Fakultni nemocnice v Praze

    Prague, 128 08

    Recruiting

  • Fakultni Nemocnice v Motole

    Prague, 150 06

    Recruiting

Other trials in Czechia

Poland7 sites, 7 recruiting

  • Przychodnia Lekarska KOMED

    Konin, 62-500

    Recruiting

  • Pratia MCM Krakow

    Krakow, 30-727

    Recruiting

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

    Recruiting

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, 60-355

    Recruiting

  • Mruk-Med Sp. z o.o

    Rzeszów, 35-234

    Recruiting

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

    Recruiting

  • Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - w Warszawie - Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej

    Warsaw, 02-781

    Recruiting

Other trials in Poland

Greece6 sites, 6 recruiting

  • Anticancer Hospital "Agios Savvas"

    Athens, 115 22

    Recruiting

  • University General Hospital of Athens "Attikon"

    Athens, 124 62

    Recruiting

  • Iaso Hospital

    Athens, 151 21

    Recruiting

  • General University Hospital of Crete

    Heraklion, 715 00

    Recruiting

  • University Hospital of Larissa

    Larissa, 41110

    Recruiting

  • Interbalkan Hospital of Thessaloniki

    Thessaloniki, 570 01

    Recruiting

Other trials in Greece

Romania6 sites, 6 recruiting

  • Institutului Oncologic Prof. Dr. Ion Chiricuță

    Cluj-Napoca, 400015

    Recruiting

  • Oncolab SRL

    Craiova, 200385

    Recruiting

  • Centrul de Oncologie Sfantul Necatarie Craiova

    Craiova, 200542

    Recruiting

  • S.C Radiotherapy Center Cluj S.R.L

    Floreşti, 407280

    Recruiting

  • Victoria Hospital SRL

    Iași, 700106

    Recruiting

  • Asociatia Oncohelp

    Timișoara, 300239

    Recruiting

Other trials in Romania

Taiwan6 sites, 6 recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

  • Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, 23561

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Canada5 sites, 5 recruiting

  • William Osler Health System- Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H8L6

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

    Recruiting

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

    Recruiting

Other trials in Canada

Netherlands4 sites, 4 recruiting

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About this study

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

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.

Being tested
Zovegalisib, Capivasertib, Fulvestrant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZovegalisibDrug

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

  • CapivasertibDrug

    Also called TRUQAP

    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

  • FulvestrantDrug

    Also called Faslodex

    500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)

Study groups in NCT06982521
Study groupRoleWhat they receive
Zovegalisib + fulvestrantExperimentalZovegalisib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer
Receives: Drug: Zovegalisib; Drug: Fulvestrant
capivasertib + fulvestrantActive comparatorcapivasertib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer
Receives: Drug: Capivasertib; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)

    Measured: The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months

Secondary outcomes (10)

  1. Overall Survival (OS) within the overall and kinase populations

    Measured: The time from randomization to the date of death by any cause, up to approximately 77 months

  2. PFS by Investigator within the overall and kinase populations

    Measured: The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months

  3. Objective Response Rate (ORR) within the overall and kinase populations

    Measured: Up to approximately 77 months

  4. Duration of Response (DOR) within the overall and kinase populations

    Measured: Up to approximately 77 months

  5. Clinical Benefit Rate (CBR) within the overall and kinase populations

    Measured: Up to approximately 77 months

  6. Occurrence/frequency of Adverse Events (AEs) and its relationship to the study drugs (safety and tolerability) within the overall and kinase populations

    Measured: Up to approximately 77 months

  7. Plasma concentrations of zovegalisib (and its metabolites as appropriate)

    Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and during Cycles 2 and 3

  8. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) scale/item scores including change from baseline and time to deterioration within overall and kinase populations

    Measured: Up to approximately 77 months

  9. EORTC Quality of Life Questionnaire Breast Cancer-Specific Module (EORTC QLQ-BR23) scale/item scores including change from baseline and time to deterioration within the overall and kinase populations

    Measured: Up to approximately 77 months

  10. Health state utility data for economic evaluation by EQ-5D-5L health state utility index within the overall and kinase populations

    Measured: Up to approximately 77 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study start26 Aug 2025
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06982521
Sponsor's protocol ID
RLY-2608-102
Acronym
ReDiscover-2
Status last verified
Jul 2026
First submitted
8 May 2025
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zovegalisib, Capivasertib and Fulvestrant in people with PIK3CA Mutation and HER2- Negative Breast Cancer, run by Relay Therapeutics, Inc. at 254 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 254 sites in United States, Spain, France, Brazil, Italy and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Relay Therapeutics, Inc (617-322-0731, ClinicalTrials@relaytx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR) (time frame: The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06982521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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