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Brief Title: Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Official Title: Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
Study ID: NCT04906395
Brief Summary: This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer. The study will also aim to assess the safety of TOL2506 in men with HR+, HER2-negative breast cancer. The Screening Period will be conducted in two parts: 1) an abbreviated, initial screening where premenopausal status will be determined prior to neoadjuvant or adjuvant chemotherapy (if planned) and 2) the full screening assessment conducted after neoadjuvant or adjuvant chemotherapy (or for subjects who enter the study without having received chemotherapy). Following the Screening Period, eligible subjects will enter into the 48 week Treatment Period in 1 of 2 groups: those who will receive tamoxifen concurrently with TOL2506 or those who will initiate therapy with an AI (letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, upon confirmation that estradiol (E2) levels of \< 20 pg/mL (testosterone levels \< 50 ng/dL in males) have been achieved. After Week 12, subjects will be allowed to switch from receiving an AI to receiving tamoxifen or from tamoxifen to AI at the discretion of the Investigator. However, a switch is not permitted 28 days prior to a dosing visit (eg, Week 24, 36, and 48 where a pre-dose blood sample for PK and PD analysis will be drawn). At the end of the Treatment Period, upon completion of the End of Study Visit (Visit 9, Week 48) subjects may be eligible to participate in a Safety Extension Study under a separate Protocol.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Marin Cancer Care, Inc, Greenbrae, California, United States
Cypress Hematology and Oncology, Parker, Colorado, United States
Holy Cross Hospital - Bienes Cancer Center, Fort Lauderdale, Florida, United States
Cancer Care Centers of Brevard, Inc., Melbourne, Florida, United States
Mount Sinai Hospital, Chicago, Illinois, United States
Baptist Health Lexington, Lexington, Kentucky, United States
Baptist Health Louisville, Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A., Glenn Dale, Maryland, United States
St. Vincent - Frontier Cancer Center, Billings, Montana, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Montefiore - Einstein Center for Cancer Care at Montefiore Medical Park, Bronx, New York, United States
Hematology Oncology Associates of Central New York, PC, East Syracuse, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Carolina Institute for Clinical Research, Fayetteville, North Carolina, United States
Oncology Hematology Care Clinical Trials, Cincinnati, Ohio, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
Tennessee Oncology, PLLC, Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Texas Oncology-Austin, Austin, Texas, United States
Texas Oncology- Dallas Presbyterian Hospital, Dallas, Texas, United States
Joe Arrington Cancer Research & Treatment Center, Lubbock, Texas, United States
Texas Oncology- San Antonio, New Braunfels, Texas, United States
Texas Oncology- Northeast Texas, Tyler, Texas, United States
Texas Oncology- Deke Slayton Cancer Center, Webster, Texas, United States
Seattle Cancer Center Alliance, Seattle, Washington, United States
Hospital Britanico de Buenos Aires, Buenos Aires, Caba, Argentina
Instituto Oncologico de Cordoba (IONC), Córdoba, Cordoba, Argentina
Centro Privado de RMI Rio Cuarto, Río Cuarto, Cordoba, Argentina
Instituto Medico de la Fundacion Estudios Clinicos, Rosario, Santa Fe, Argentina
Fundacion CENIT, Caba, , Argentina
Hospital Aleman, Ciudad autónoma de Buenos Aires, , Argentina
Sanatorio Allende- Sede Nueva Cordoba, Cordoba, , Argentina
Hospital Sao Rafael, Salvador, Bahia, Brazil
Oncocentro Servicos Medicos e Hospitalares Ltda, Fortaleza, Ceara, Brazil
Centro Regional Integrado de Oncologia, Fortaleza, Ceara, Brazil
Hospital Araujo Jorge, Goiania, Goias, Brazil
Onconeo, Campo Grande, Mato Grosso Do Sul, Brazil
Hospital Erasto Gaertner, Curitiba, Parana, Brazil
Hospital do Cancer de Londrina, Londrina, Parana, Brazil
Instituto D Or de Pesquisa e Ensino - Hospital Esperanca Recife, Recife, Pernambuco, Brazil
Uniao Brasileira de Educacao e Assistencia, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Amor Amazonia, Porto Velho, Rondonia, Brazil
Fundacao Pio XII, Barretos, Sao Paulo, Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC, Santo André, Sao Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria, São Paulo, Sao Paulo, Brazil
Irmamandade de Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude, Rio De Janeiro, , Brazil
Lions Gate Hospital, North Vancouver, British Columbia, Canada
Sunnybrook Odette Cancer Centre Clinical Research Program, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Amiisto Atencion Medica Integral, Investigacion Y Terapia Oncologica S.A De C.V., Mexico City, Cdmx, Mexico
Unidad de Medicina Especializada SMA, San Juan del Rio, Queretaro, Mexico
Clinica EMA, Mexico City, , Mexico
FAICIC S. de R.L. de C.V., Veracruz, , Mexico
FDI Clinical Research, San Juan, , Puerto Rico
Name: E P Hamilton
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR