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Search / Trial NCT06492616

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

Elegant Breast Cancer Stage Ii Breast Cancer Stage Iii Breast Cancer Female Breast Cancer, Male High Risk Breast Cancer High Risk Breast Carcinoma Er Positive Breast Cancer Er Positive Her 2 Negative Breast Cancer Er Positive/Her2 Low Breast Cancer Breast Cancer, Er+, Her2 Adjuvant Adjuvant Therapy

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.

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

0 patients applied

Trial Officials

Medical Director

Study Director

Stemline Therapeutics, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported