A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT06492616
- Lead Sponsor
- Stemline Therapeutics, Inc.
- Brief Summary
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4220
- Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 2 and in situ hybridization [ISH]-negative)] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Participants considered at high risk of recurrence at initial staging
- Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
- Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.
Key
- Participants with inflammatory breast cancer
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer
- Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
- Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (SoC) Endocrine Therapy Letrozole Participants will receive the SoC endocrine therapy that was used prior to randomization: * AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or * Tamoxifen 20 mg QD Elacestrant Elacestrant Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years Standard of Care (SoC) Endocrine Therapy Anastrozole Participants will receive the SoC endocrine therapy that was used prior to randomization: * AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or * Tamoxifen 20 mg QD Standard of Care (SoC) Endocrine Therapy Exemestane Participants will receive the SoC endocrine therapy that was used prior to randomization: * AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or * Tamoxifen 20 mg QD Standard of Care (SoC) Endocrine Therapy Tamoxifen Participants will receive the SoC endocrine therapy that was used prior to randomization: * AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or * Tamoxifen 20 mg QD
- Primary Outcome Measures
Name Time Method Invasive Breast Cancer-Free Survival (IBCFS) Up to 5 years Assessed by the time from date of randomization to the date of first occurrence of:
* Ipsilateral invasive breast tumor recurrence
* Local/regional invasive breast cancer recurrence
* Distant recurrence
* Contralateral invasive breast cancer, or
* Death attributable to any cause
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) Up to 5 years plus 28 days Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant Predose up to 4 hours postdose Overall Survival (OS) Up to 5 years Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5 Distant Relapse-Free Survival (DRFS) Up to 5 years Assessed by the time from date of randomization to the date of first occurrence of:
* Distant recurrence, or
* Death attributable to any causeInvasive Disease-Free Survival (IDFS) Up to 5 years Assessed by the time from date of randomization to the date of first occurrence of:
* Local/regional recurrence
* Contralateral recurrence
* Second primary non-breast invasive cancer
* Distant recurrence, or
* Death attributable to any causeChange from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30 Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5 Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42) Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5 Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant Predose up to 4 hours postdose Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168) Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Trial Locations
- Locations (172)
Hospital Beata Maria Ana
🇪🇸Madrid, Spain
Southern Cancer Center, PC
🇺🇸Daphne, Alabama, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Highlands Oncology Group, PA
🇺🇸Springdale, Arkansas, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Cancer and Blood Research Center, LLC
🇺🇸Los Alamitos, California, United States
UCLA Department of Medicine - Hematology/Oncology
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Dignity Health dba Health Research Institute
🇺🇸Sacramento, California, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Sansum Clinic
🇺🇸Solvang, California, United States
St.Joseph Hospital- Cancer Centers of Colorado
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP
🇺🇸Lone Tree, Colorado, United States
AHMG Hematology and Oncology
🇺🇸Parker, Colorado, United States
Cancer Care at CommonSpirit St. Anthony North Hospital
🇺🇸Westminster, Colorado, United States
Yale New Haven Hospital- Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
AdventHealth Orlando Infusion Center
🇺🇸Orlando, Florida, United States
Cancer Care Centers of Brevard (CCCB) - Palm Bay
🇺🇸Palm Bay, Florida, United States
Memorial Healthcare System
🇺🇸Pembroke Pines, Florida, United States
University Blood & Cancer Center, LLC
🇺🇸Athens, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Kaiser Permanente Hawaii Moanalua Medical Center
🇺🇸Honolulu, Hawaii, United States
Illinois Cancer Specialists
🇺🇸Arlington Heights, Illinois, United States
Northwest Cancer Centers, PC
🇺🇸Dyer, Indiana, United States
Mission Cancer and Blood
🇺🇸Des Moines, Iowa, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Ascension St. Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
The Cancer & Hematology Centers
🇺🇸Grand Rapids, Michigan, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
NHO Revive Research Institute LLC
🇺🇸Lincoln, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
🇺🇸Omaha, Nebraska, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
John Theurer Ctr-Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
Rutgers Cancer Institute
🇺🇸New Brunswick, New Jersey, United States
Exigent Research LLC/New Mexico Oncology Hematology Consultants Ltd.
🇺🇸Albuquerque, New Mexico, United States
Cayuga Medical Center
🇺🇸Ithaca, New York, United States
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cape Fear Valley Medical Center
🇺🇸Fayetteville, North Carolina, United States
Miami Valley Hospital South
🇺🇸Centerville, Ohio, United States
Oncology_Hematology Care Clinical Trials, LLC
🇺🇸Fairfield, Ohio, United States
Oregon Oncology Specialists
🇺🇸Salem, Oregon, United States
Northwest Cancer Specialists, P.C.
🇺🇸Tigard, Oregon, United States
Consultants In Medical Oncology and Hematology, P.C.
🇺🇸Broomall, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Alliance Cancer Specialists, PC
🇺🇸Media, Pennsylvania, United States
Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Hendrick Cancer Center
🇺🇸Abilene, Texas, United States
Texas Oncology - DFW
🇺🇸Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology - San Antonio
🇺🇸New Braunfels, Texas, United States
Mays Cancer Center
🇺🇸San Antonio, Texas, United States
Texas Oncology- Central South
🇺🇸Weslaco, Texas, United States
Virginia Oncology Associates
🇺🇸Newport News, Virginia, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc
🇺🇸Wytheville, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Cancer Care Northwest
🇺🇸Spokane Valley, Washington, United States
Northwest Medical Specialties PLLC
🇺🇸Tacoma, Washington, United States
University of Wisconsin Carbone Cancer Center- University Hospital
🇺🇸Madison, Wisconsin, United States
UW Cancer Center at ProHealth Care
🇺🇸Waukesha, Wisconsin, United States
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Lake Macquarie Private Hospital - Oncology
🇦🇺Gateshead, New South Wales, Australia
Mater Hospital Sydney
🇦🇺North Sydney, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Icon Cancer Centre Townsville
🇦🇺Hyde Park, Queensland, Australia
Icon Cancer Centre Southport
🇦🇺Southport, Queensland, Australia
Icon Cancer Centre Wesley
🇦🇺Auchenflower, Quuensland, Australia
Icon Cancer Centre Kurralta Park
🇦🇺Kurralta Park, South Australia, Australia
Goulburn Valley Health
🇦🇺Shepparton, Victoria, Australia
Breast Cancer Research Centre
🇦🇺Nedlands, Western Australia, Australia
Icon Cancer Centre Hobart
🇦🇺Hobart, Australia
Mid North Coast Cancer Institute
🇦🇺Port Macquarie, Australia
Hanusch Krankenhaus
🇦🇹Wien, Austria
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Regional Hospital Saint-Jerome
🇨🇦Saint-Jerome, Quebec, Canada
FN Kralovske Vinohrady - Radioterapeuticka a onkologicka klinika
🇨🇿Praha 10, Czechia
Centre Hospitalier Regional et Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz
🇫🇷Besancon, Alpes-Maritimes, France
Institut de Cancerologie de l'Ouest - Oncology
🇫🇷St. Herblain, Loire-Atlantique, France
Institut Gustave Roussy
🇫🇷Villejuif, Val-de-Marne, France
Centre Hospitalier Universitaire De Poitiers - Pôle Régional de Cancérologie
🇫🇷Poitiers, France
Institut de Cancérologie de Lorraine
🇫🇷Vandœuvre-Lès-Nancy Cedex 03, France
Universitätsmedizin Mannheim (UMM)
🇩🇪Mannheim, Baden-Württemberg, Germany
'Klinikum Esslingen GmbH
🇩🇪Esslingen am Neckar, Esslingen a.N., Germany
'Schwerpunktpraxis Fuer Gynaekologie und Onkologie
🇩🇪Brandenburg, Fuerstenwalde /Spree, Germany
Klinikum Worms gGmbH
🇩🇪Worms, Rheinland-Pfalz, Germany
Bacs-Kiskun Varmegyei Oktatakorhaz
🇭🇺Kecskemét, Bács-Kiskun, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hajdú-Bihar, Hungary
Nograd Varmegyei Szent Lazar Korhaz
🇭🇺Salgótarján, Szabolcs-Szatmár-Bereg, Hungary
Budapesti Uzsoki Utcai Korhaz
🇭🇺Budapest, Hungary
IRST Dino Amadori IRCCS
🇮🇹Meldola, Forli-Cesena, Italy
IRCCS San Gerardo dei Tintori
🇮🇹Monza, Monza E Brianza, Italy
Centro di Riferimento Oncologico, IRCCS
🇮🇹Aviano, Pordenone, Italy
Ospedale Casa Sollievo della Sofferen IRCCS, Opera di San Pio da Pietrelcina
🇮🇹San Giovanni Rotondo, Puglia, Italy
Istituto Europeo di Oncologia IRCCS
🇮🇹Milano, Italy
Azienda USL Toscana Centro
🇮🇹Prato, Italy
Irccs Crob
🇮🇹Rionero In Vulture, Italy
U.O. Ginecologia Oncologica - Fondazione Policlinico A. Gemelli
🇮🇹Roma, Italy
IRCCS Istituto Nazionale Tumori Regina Elena,UOSD Sperimentazioni di fase IV
🇮🇹Roma, Italy
Ospedale Sacro cuore Don Calabria- Negrar di Valpolicella
🇮🇹Verona, Italy
Chungbuk National University Hospital
🇰🇷Cheongju-si, Chungcheongbugdo [Ch'ungch'ongbuk-do], Korea, Republic of
Hospital CUF Descobertas
🇵🇹Lisboa, Portugal
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Incheon Gwang'yeogsi [Inch'n-Kwangyokshi], Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Gangnam Severance Hospital - Oncology
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
National Cancer Center
🇰🇷Gyeonggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Hospital Pulau Pinang - Rheumatology
🇲🇾George Town, Pulau Pinang, Malaysia
Pantai Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Oncolab - Medical Oncology
🇷🇴Craiova, Dolj, Romania
UKM Medical Centre
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Beacon Hospital
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Universiti Malaya Medical Centre
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia
Institut Kanser Negara
🇲🇾Putrajaya, Wilayah Persekutuan, Malaysia
Hospital Sultan Ismail
🇲🇾Johor Bahru, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Mahkota Medical Center
🇲🇾Melaka, Malaysia
Elisabeth-TweeSteden Ziekenhuis
🇳🇱Tilburg, Noord-Brabant, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
IP Clinic Sp. z o.o.
🇵🇱Łódź, Lodz, Poland
Hospital Beatriz Ângelo. Hospital de Loures - Oncologia Medica
🇵🇹Loures, Lisboa, Portugal
Centrul de Oncologie Sf. Nectarie
🇷🇴Craiova, Dolj, Romania
Spitalul Clinic Filantropia
🇷🇴Bucuresti, Romania
Spitalul Clinic CF Nr 2 Bucuresti
🇷🇴Bucuresti, Romania
Memorial Healthcare International
🇷🇴Bucuresti, Romania
Radiotherapy Center Cluj
🇷🇴Floreşti, Romania
Raffles Hospital
🇸🇬Singapore, Singapore
Hospital Alvaro Cunqueiro
🇪🇸Vigo, A Coruña, Spain
Hospital Universitario de Canarias
🇪🇸San Cristobal de la Laguna, Canarias, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Andalucia, Spain
H. Virgen de Valme
🇪🇸Sevilla, Andalucia, Spain
Complexo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Clínico Universitario Virgen De La Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Universitari Vall D Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital de La Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
H.U. Insular Gran Canaria
🇪🇸Las Palmas De Gran Canaria, Spain
H.U Arnau De Vilanova Lleida
🇪🇸Lleida, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Virgen De La Victoria
🇪🇸Málaga, Spain
Hospital Universitario de Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Clinico Universitario De Valencia
🇪🇸Valencia, Spain
Hospital Quironsalud Valencia
🇪🇸Valencia, Spain
Tumor Zentrum Aarau
🇨🇭Aarau, Aargau (de), Switzerland
Brust-Zentrum AG Zurich
🇨🇭Zürich, Zürich (de), Switzerland
Spitaeler Schaffhausen Kantonspital
🇨🇭Schaffhausen, Switzerland
Changhua Christian Medical Foundation Changhua Christian Hospital
🇨🇳Changhua City, Taiwan
Maidstone Hospital Kent Oncology Centre
🇬🇧Maidstone, United Kingdom