A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Launched by STEMLINE THERAPEUTICS, INC. · Jul 1, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called elacestrant to see how well it works compared to standard hormonal treatments in women and men with early-stage breast cancer that is hormone receptor-positive (ER+) and HER2-negative (HER2-). The focus is on patients who have a higher risk of their cancer coming back after treatment. The trial is currently looking for participants who are between the ages of 65 and 74, have already had some hormonal therapy for their cancer, and meet certain health criteria.
If you join the trial, you will be randomly assigned to receive either elacestrant or the standard treatment currently used for breast cancer. Throughout the study, you will have regular check-ins with the medical team to monitor your health and how well the treatment is working. It’s important to know that some people may not qualify for the trial due to specific health history, such as having inflammatory breast cancer or a recent history of other cancers. This trial aims to find out if elacestrant can provide better outcomes for patients like you, so your participation could contribute to important advancements in breast cancer treatment.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 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 Exclusion Criteria:
- • 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.
About Stemline Therapeutics, Inc.
Stemline Therapeutics, Inc. is a biopharmaceutical company dedicated to the development of innovative therapeutics for the treatment of cancer. Founded with a focus on advancing novel stem cell-targeted therapies, Stemline leverages cutting-edge science to address unmet medical needs in oncology. The company is committed to rigorously conducting clinical trials that evaluate the safety and efficacy of its product candidates, aiming to improve patient outcomes and enhance the quality of life for those affected by hematologic malignancies and solid tumors. Through its pioneering research and development efforts, Stemline strives to transform the landscape of cancer treatment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sacramento, California, United States
Boston, Massachusetts, United States
New York, New York, United States
Providence, Rhode Island, United States
Boston, Massachusetts, United States
Seattle, Washington, United States
Boston, Massachusetts, United States
Atlanta, Georgia, United States
Westmead, New South Wales, Australia
Newport News, Virginia, United States
Madrid, , Spain
Jacksonville, Florida, United States
Valencia, , Spain
Madrid, , Spain
Fort Myers, Florida, United States
Boston, Massachusetts, United States
Baltimore, Maryland, United States
Tampa, Florida, United States
Box Hill, Victoria, Australia
Wynnewood, Pennsylvania, United States
Seattle, Washington, United States
Hershey, Pennsylvania, United States
Newport Beach, California, United States
Salt Lake City, Utah, United States
Baltimore, Maryland, United States
Fayetteville, North Carolina, United States
Burlington, Vermont, United States
Tacoma, Washington, United States
London, , United Kingdom
Montreal, Quebec, Canada
Woodville, South Australia, Australia
Wichita, Kansas, United States
Columbia, Maryland, United States
Nashville, Tennessee, United States
Madrid, , Spain
Houston, Texas, United States
Clayton, Victoria, Australia
Eindhoven, , Netherlands
Lincoln, Nebraska, United States
Madrid, , Spain
El Palmar, Murcia, Spain
Lugo, , Spain
Richmond, Virginia, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Málaga, , Spain
Fairfax, Virginia, United States
West Palm Beach, Florida, United States
Centerville, Ohio, United States
Napoli, , Italy
Seoul, , Korea, Republic Of
Barcelona, , Spain
Siena, , Italy
Charleston, South Carolina, United States
Shepparton, Victoria, Australia
A Coruña, , Spain
Bern, , Switzerland
Seoul, , Korea, Republic Of
Incheon, , Korea, Republic Of
Waukesha, Wisconsin, United States
Córdoba, , Spain
Tucson, Arizona, United States
Arlington Heights, Illinois, United States
Paris Cedex 20, , France
Milano, , Italy
Melaka, , Malaysia
Darlinghurst, New South Wales, Australia
Atlanta, Georgia, United States
Abilene, Texas, United States
Solvang, California, United States
Seoul, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Sassari, , Italy
Ipoh, Perak, Malaysia
Springdale, Arkansas, United States
Saint Petersburg, Florida, United States
Memphis, Tennessee, United States
Cachoeiro De Itapemirim, , Brazil
Ithaca, New York, United States
Villejuif, Val De Marne, France
Spokane Valley, Washington, United States
Debrecen, , Hungary
Honolulu, Hawaii, United States
London, , United Kingdom
Wien, , Austria
Liestal, , Switzerland
Johor Bahru, , Malaysia
Tigard, Oregon, United States
Cheongju Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Debrecen, Hajdú Bihar, Hungary
Leuven, Vlaams Brabant, Belgium
Daphne, Alabama, United States
Ulsan, , Korea, Republic Of
Lisboa, , Portugal
Macquarie Park, New South Wales, Australia
Busan, , Korea, Republic Of
Napoli, , Italy
La Jolla, California, United States
Southport, Queensland, Australia
Macerata, , Italy
Houston, Texas, United States
Florham Park, New Jersey, United States
North Sydney, New South Wales, Australia
Gilbert, Arizona, United States
Mechanicsville, Virginia, United States
Vigo, , Spain
San Antonio, Texas, United States
New Brunswick, New Jersey, United States
Bucuresti, , Romania
Los Angeles, California, United States
Gyeonggi Do, , Korea, Republic Of
New Orleans, Louisiana, United States
Lone Tree, Colorado, United States
Salem, Oregon, United States
Orlando, Florida, United States
Sevilla, Andalucia, Spain
Tilburg, Noord Brabant, Netherlands
Madrid, , Spain
Barcelona, , Spain
New York, New York, United States
East Syracuse, New York, United States
Rionero In Vulture, , Italy
Buenos Aires, , Argentina
Adelaide, South Australia, Australia
Brussels, , Belgium
Sant Cugat Del Valles, Barcelona, Spain
Jaén, , Spain
Coimbra, , Portugal
Hasselt, Limburg, Belgium
Hořovice, , Czechia
Springdale, Arkansas, United States
York, Pennsylvania, United States
Warszawa, Mazowieckie, Poland
Broomall, Pennsylvania, United States
Des Moines, Iowa, United States
Hobart, , Australia
Seongnam Si, Gyeonggido, Korea, Republic Of
Aarau, , Switzerland
Incheon, , Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Budapest, , Hungary
Minneapolis, Minnesota, United States
Adana, , Turkey
Dallas, Texas, United States
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Nashville, Tennessee, United States
New Braunfels, Texas, United States
Craiova, Dolj, Romania
Pembroke Pines, Florida, United States
Cluj Napoca, Cluj, Romania
Fairfield, Ohio, United States
Lincoln, Nebraska, United States
Kurralta Park, South Australia, Australia
Cheongju Si, Chungcheongbugdo [Ch'ungch'ongbuk Do], Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Seoul, N/A (Not Applicable), Korea, Republic Of
Witten, Nordrhein Westfalen, Germany
Saint Louis, Missouri, United States
Wichita, Kansas, United States
Los Alamitos, California, United States
Singapore, , Singapore
Salgótarján, , Hungary
Waukesha, Wisconsin, United States
Grand Rapids, Michigan, United States
Dyer, Indiana, United States
Sacramento, California, United States
Altamonte Springs, Florida, United States
Weslaco, Texas, United States
Madison, Wisconsin, United States
Sint Niklaas, Oost Vlaanderen, Belgium
Ankara, , Turkey
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Prato, , Italy
Westminster, Colorado, United States
Palm Bay, Florida, United States
Hackensack, New Jersey, United States
Albuquerque, New Mexico, United States
Media, Pennsylvania, United States
Wytheville, Virginia, United States
Auchenflower, Quuensland, Australia
Port Macquarie, , Australia
Saint Jerome, Quebec, Canada
Esslingen Am Neckar, Esslingen A.N., Germany
Brandenburg, Fuerstenwalde /Spree, Germany
łódź, Lodz, Poland
Bucuresti, , Romania
Floreşti, , Romania
Sevilla, Andalucia, Spain
Craiova, Dolj, Romania
Parker, Colorado, United States
Athens, Georgia, United States
Hyde Park, Queensland, Australia
Praha 10, , Czechia
Verona, , Italy
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Kuala Lumpur, , Malaysia
Bucuresti, , Romania
Vigo, A Coruña, Spain
Las Palmas De Gran Canaria, , Spain
Santiago De Compostela, , Spain
Schaffhausen, , Switzerland
Maidstone, , United Kingdom
Avignon, Vaucluse, France
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Baltimore, Maryland, United States
Omaha, Nebraska, United States
Gateshead, New South Wales, Australia
Nedlands, Western Australia, Australia
Besancon, Alpes Maritimes, France
St. Herblain, Loire Atlantique, France
Poitiers, , France
Vandœuvre Lès Nancy Cedex 03, , France
Mannheim, Baden Württemberg, Germany
Worms, Rheinland Pfalz, Germany
Kecskemét, Bács Kiskun, Hungary
Salgótarján, Szabolcs Szatmár Bereg, Hungary
Meldola, Forli Cesena, Italy
Monza, Monza E Brianza, Italy
Aviano, Pordenone, Italy
San Giovanni Rotondo, Puglia, Italy
Roma, , Italy
Roma, , Italy
George Town, Pulau Pinang, Malaysia
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Putrajaya, Wilayah Persekutuan, Malaysia
Loures, Lisboa, Portugal
Singapore, , Singapore
San Cristobal De La Laguna, Canarias, Spain
Lleida, , Spain
Valencia, , Spain
Aarau, Aargau (De), Switzerland
Zürich, Zürich (De), Switzerland
Changhua City, , Taiwan
Sevilla, , Spain
Scottsdale, Arizona, United States
Rochester, Minnesota, United States
Nashville, Tennessee, United States
Lismore, New South Wales, Australia
Charleroi, Hainaut, Belgium
Brno, Brno Město, Czechia
Praha 4, , Czechia
Bezannes, Marne, France
Eggenfelden, Bayern, Germany
Rüdersdorf, Brandenburg, Germany
Frattamaggiore, Napoli, Italy
Firenze, , Italy
Milano, , Italy
Rimini, , Italy
Roma, , Italy
Poznan, Wielkopolskie, Poland
Lisboa, , Portugal
Setúbal, , Portugal
Truro, Cornwall, United Kingdom
Seoul, , Korea, Republic Of
Brno, , Czechia
Mannheim, , Germany
Brandenburg, , Germany
Kecskemét, , Hungary
Zürich, , Switzerland
San Marcos, California, United States
Boca Raton, Florida, United States
Miami, Florida, United States
Allentown, Pennsylvania, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
C.A.B.A., , Argentina
Buenos Aires, , Argentina
Ottignies, Brabant Wallon, Belgium
Bruxelles, Brussels Capital Region, Belgium
Liège, , Belgium
Namur, , Belgium
Curitiba, , Brazil
Lajeado, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Velho, , Brazil
Ribeirão Preto, , Brazil
São José Do Rio Preto, , Brazil
São Paulo, , Brazil
Odense, South Denmark, Denmark
Sønderborg, South Denmark, Denmark
Chambray Lès Tours, Indre Et Loire, France
Limoges, Limousin, France
Reims, Marne, France
Fréjus, Var, France
Mönchengladbach, Nordrhein Westfalen, Germany
Dresden, Sachsen, Germany
Leipzig, Sachsen, Germany
Pécs, Baranya, Hungary
Viagrande, Catania, Italy
Bologna, Emilia Romagna, Italy
Cremona, , Italy
Genova, , Italy
Novara, , Italy
Otwock, Mazowieckie, Poland
Gdynia, Pomorskie, Poland
Vila Franca De Xira, Lisboa, Portugal
Lisboa, , Portugal
Craiova, Dolj, Romania
Timisoara, Timis, Romania
Iasi, , Romania
Móstoles, Madrid, Spain
Valencia, Navarra, Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Baden, , Switzerland
Saint Gallen, , Switzerland
Taichung City, Taichung, Taiwan
Taipei City, Taoyuan, Taiwan
Taiyuan, Taoyuan, Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Sakarya, Adapazari, Turkey
İzmit, Kocaeli, Turkey
Ankara, , Turkey
Aydin, , Turkey
Diyarbakır, , Turkey
Samsun, , Turkey
London, England, United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Stemline Therapeutics, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported