Spots Global Cancer Trial Database for Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer
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Trial Identification
Brief Title: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer
Official Title: Randomized Crossover Ph3 to Evaluate Efficacy/Safety of Enobosarm Monotherapy vs Active Control for Treatment of AR+/ER+/HER2- MBC With AR Staining Previously Treated w/Nonsteroidal Aromatase Inhibitor, SERD & CDK 4/6 Inhibitor
Study ID: NCT04869943
Conditions
Study Description
Brief Summary: To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).
Detailed Description: This study is a multicenter, randomized, open-label, two treatment arm, efficacy and safety study, comprised of two sections, the main study and the post-study extension period. Subjects will be randomized to the two treatment arms in a 1:1 fashion (into the main study), with the opportunity for subjects initially randomized to the Control Treatment Group to cross over to receive the investigational treatment in the post-study extension period. The primary efficacy endpoint of the study will be the median rPFS. Subjects will continue study treatment until disease progression confirmed by blinded independent central reader (BICR) is observed. A safety follow up visit will occur approximately 30 days after last dose of study drug. Thereafter, survival follow up will be completed monthly for one year. Survival follow up may be completed by phone or records review. After one year, survival follow up will be completed every 90 days. After radiographic progression (by RECIST 1.1) is confirmed by blinded independent central reader (BICR) and have received approval from Medical Monitor, subjects in the Control Treatment Group may be crossed over to receive enobosarm treatment (9mg per day). Treatment will continue in this population (Enobosarm Post-study Group (EPG)) until radiographic progression (by RECIST 1.1), confirmed by BICR, is observed. The efficacy database for this crossover group will be completely separate from the main portion of the study and the data will be analyzed separately.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Centers, Chandler, Arizona, United States
Banner Health/ Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
The Oncology Insitute of Hope and Innovation, Glendale, California, United States
Marin Cancer Care, Inc., Greenbrae, California, United States
California Research Institute (CRI), Los Angeles, California, United States
University of California San Francisco Comprehensive Cancer Center, San Francisco, California, United States
Providence Medical Group, Santa Rosa, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Morton Plant Hospital/ BayCare Health System, Inc, Clearwater, Florida, United States
University of Miami- Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Woodlands Medical Specialists, PA, Pensacola, Florida, United States
Miami Cancer Institute, Plantation MCIP, Plantation, Florida, United States
University Cancer & Blood Center, Athens, Georgia, United States
Blessing Corporate Services, Quincy, Illinois, United States
MBCCOP - LSU Health Sciences Center, Shreveport, Louisiana, United States
Dana-Farber Cancer Institute Breast Oncology, Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Astera Cancer Care, East Brunswick, New Jersey, United States
Inspira Medical Center Mullica Hill, Mullica Hill, New Jersey, United States
Inspira Medical Center, Vineland, New Jersey, United States
The Lindner Center for Research and Education at the Christ Hospital, Cincinnati, Ohio, United States
Magee-Women's Hospital, Pittsburgh, Pennsylvania, United States
Tidelands Health, Murrells Inlet, South Carolina, United States
Tennessee Cancer Specialists, Knoxville, Tennessee, United States
Baptist Clinical Research Institute, Nashville, Tennessee, United States
Texas Oncology Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia, United States
MultiCare Institute for Research and Innovation, Puyallup, Washington, United States
Cancer Care Northwest, Spokane, Washington, United States
MultiCare Institute for Research and Innovation, Spokane, Washington, United States
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin, , Poland
Specjalistyczny Szpital Onkologiczny NU-MED, Maków Mazowiecki, , Poland
"Oddział Onkologii Klinicznej i Chemioterapii Europejskie Centrum Zdrowia Otwock", Otwock, , Poland
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Warsaw, , Poland
Wojewódzka Przychodnia Onkologiczna, Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi, Łódź, , Poland
Instytut Centrum Zdrowia Matki Polki, Łódź, , Poland
A Coruña University Hospital, A Coruña, , Spain
Hospital Universitari Dexeus, Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, , Spain
Institut Catala d'Oncologia (ICO), Barcelona, , Spain
Hospital Universitari Arnau de Vilanova de Lleida, Lleida, , Spain
Hospital Ruber Internacional, Madrid, , Spain
Hospital Universitario 12 de Octubre (H12O), Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Clínico Universitario de Valencia (CHUV), Valencia, , Spain
Municipal Institution "Dnipropetrovsk City Multi-field Clinical Hospital #4", Dnepropetrovsk state m, Dnepropetrovsk, , Ukraine
State institution "V.T. Zaycev Institute of general and urgent surgery of National academy medical sciences of Ukraine", Kharkiv, , Ukraine
Khmelnytsky Regional Antitumor Center, Department of Breast, Skin, Soft Tissues and Bones Tumorsa, Khmelnytskyi, , Ukraine
Kyiv City Clinical Oncology Center, Kyiv, , Ukraine
Odessa Regional Oncological Dispensary, Odessa, , Ukraine
Contact Details
Name: Barnette
Affiliation: Veru Inc.
Role: STUDY_CHAIR
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