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 May 23, 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
Boston, Massachusetts, United States
Westmead, New South Wales, Australia
Newport News, Virginia, United States
Madrid, , Spain
Valencia, , Spain
Madrid, , Spain
Fort Myers, Florida, United States
Boston, Massachusetts, United States
Baltimore, Maryland, United States
Seattle, Washington, United States
Hershey, Pennsylvania, United States
Newport Beach, California, United States
Baltimore, Maryland, United States
Fayetteville, North Carolina, United States
Tacoma, Washington, United States
Montreal, Quebec, Canada
Wichita, Kansas, United States
Columbia, Maryland, United States
Nashville, Tennessee, United States
Madrid, , Spain
Houston, Texas, United States
Eindhoven, , Netherlands
Lincoln, Nebraska, United States
Madrid, , Spain
El Palmar, Murcia, Spain
Richmond, Virginia, United States
Málaga, , Spain
West Palm Beach, Florida, United States
Centerville, Ohio, United States
Barcelona, , Spain
Charleston, South Carolina, United States
Shepparton, Victoria, Australia
A Coruña, , Spain
Seoul, , Korea, Republic Of
Waukesha, Wisconsin, United States
Córdoba, , Spain
Tucson, Arizona, United States
Arlington Heights, Illinois, United States
Milano, , Italy
Melaka, , Malaysia
Darlinghurst, New South Wales, Australia
Atlanta, Georgia, United States
Abilene, Texas, United States
Solvang, California, United States
Gyeonggi Do, , Korea, Republic Of
Springdale, Arkansas, United States
Saint Petersburg, Florida, United States
Ithaca, New York, United States
Villejuif, Val De Marne, France
Spokane Valley, Washington, United States
Honolulu, Hawaii, United States
Wien, , Austria
Johor Bahru, , Malaysia
Tigard, Oregon, United States
Seoul, , Korea, Republic Of
Debrecen, Hajdú Bihar, Hungary
Daphne, Alabama, United States
Ulsan, , Korea, Republic Of
Lisboa, , Portugal
Busan, , Korea, Republic Of
La Jolla, California, United States
Southport, Queensland, Australia
Florham Park, New Jersey, United States
North Sydney, New South Wales, Australia
Gilbert, Arizona, United States
Mechanicsville, Virginia, United States
San Antonio, Texas, United States
New Brunswick, New Jersey, United States
Bucuresti, , Romania
Los Angeles, California, United States
Gyeonggi Do, , Korea, Republic Of
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
Rionero In Vulture, , Italy
Springdale, Arkansas, United States
Broomall, Pennsylvania, United States
Des Moines, Iowa, United States
Hobart, , Australia
Seongnam Si, Gyeonggido, Korea, Republic Of
Incheon, Incheon Gwang'yeogsi [Inch'n Kwangyokshi], Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Budapest, , Hungary
Minneapolis, Minnesota, United States
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
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
Saint Louis, Missouri, United States
Wichita, Kansas, United States
Los Alamitos, California, United States
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
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
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
Patients applied
Trial Officials
Medical Director
Study Director
Stemline Therapeutics, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported