Spots Global Cancer Trial Database for ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
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Trial Identification
Brief Title: ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
Official Title: ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)
Study ID: NCT05596409
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with ER+/HER2- advanced/metastatic breast cancer who received no prior CDK4/6i in the metastatic setting.
Detailed Description: This is a Phase 2 trial evaluating the efficacy of elacestrant in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting. The study duration for each patient is estimated to be: * Screening Phase: Up to 21 days prior to Cycle 1, Day 1 (C1/D1); * Treatment Phase: From C1/D1 until the date of radiologically documented progression, or treatment discontinuation due to other reasons. * Survival Follow-Up Phase: All patients will be followed for survival approximately every 3 months up to 24 months after enrollment of the last patient. Patients will be followed for AEs for 28 days after the last treatment administration.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group, PA, Springdale, Arkansas, United States
OPN Healthcare, Arcadia, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Morton Plant Hospital - Baycare Health System, Clearwater, Florida, United States
Inventa Center for Cancer Research at Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Alliance for Multispecialty Research, Merriam, Kansas, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
The Toledo Clinic, Toledo, Ohio, United States
UT Health San Antonio Mays Cancer Center, San Antonio, Texas, United States
Quality Cancer Care Alliance (QCCA) Northwest Medical Specialties, Tacoma, Washington, United States
Hospital São Lucas PUCRS - Centro de Pesquisa em Oncologia (CPO), Porto Alegre, Rio Granda Do Sul, Brazil
Centro de Pesquisas Oncologicas, Florianópolis, Santa Catarina, Brazil
Hospital de Amor de Barretos, Barretos, São Paulo, Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia- CEPHO, Santo Andre, São Paulo, Brazil
Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda, São Paulo, , Brazil
COMPLEX ONCOLOGICAL CENTER - Shumen, Shumen, , Bulgaria
COC Veliko Tarnovo, Veliko Tarnovo, , Bulgaria
Cancer Research Centre, Tbilisi, , Georgia
Innova Medical Center, Tbilisi, , Georgia
LTD Simon Khechinashvili University Clinic, Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla, Tbilisi, , Georgia
Institute of Clinical Oncology, Tbilisi, , Georgia
Todua Clinic, Tbilisi, , Georgia
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca, Cluj Napoca, Cluj, Romania
Centrul de Oncologie "Sf. Nectarie", Craiova, Dolj, Romania
Contact Details
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