Spots Global Cancer Trial Database for Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy
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Trial Identification
Brief Title: Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy
Official Title: An Open-Label Phase 2 Study of MLN0128 (A TORC1/2 Inhibitor) in Combination With Fulvestrant in Women With ER-Positive/HER2-Negative Advanced or Metastatic Breast Cancer That Has Progressed During or After Aromatase Inhibitor Therapy
Study ID: NCT02756364
Conditions
Study Description
Brief Summary: The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants treated with single-agent fulvestrant.
Detailed Description: The drug being tested in this study is called sapanisertib. Sapanisertib is being tested to treat postmenopausal women with advanced or metastatic estrogen receptor (ER) positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer that has progressed during or after aromatase inhibitor (AI) therapy. This study will evaluate the efficacy and safety of combination of fulvestrant + daily sapanisertib and fulvestrant + weekly sapanisertib compared with fulvestrant alone. The study will enroll approximately 153 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Fulvestrant 500 mg * Fulvestrant 500 mg + Sapanisertib 4 mg * Fulvestrant 500 mg + Sapanisertib 30 mg All participants will receive either fulvestrant 500 mg intramuscularly (IM), fulvestrant 500 mg + sapanisertib 4 mg daily or fulvestrant 500 mg + sapanisertib 30 mg weekly. This multicenter trial will be conducted Spain and the USA. Participants will make multiple visits to the clinic, and end of treatment (EOT) visit which will occur 30 to 40 days after receiving their last dose of study drug or before the start of any subsequent anticancer therapy. After EOT, participants will be followed for progression free survival (PFS) and overall survival (OS).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Southern Cancer Center, PC, Mobile, Alabama, United States
CBCC Global Research 6501 Truxtun Avenue Bakersfield, CA, Bakersfield, California, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare, Fullerton, California, United States
UCSD Moores Cancer Center, La Jolla, California, United States
UCLA Hematology/Oncology David Geffen School of Medicine, Los Angeles, California, United States
North County Oncology, Oceanside, California, United States
Torrance Health Association, Redondo Beach, California, United States
PHC-SLO Oncology and Hematology, San Luis Obispo, California, United States
Cancer Center of Santa Barbara With Sansum Clinic, Santa Barbara, California, United States
University of Colorado Cancer Center-Anschutz Cancer Pavilion (ACP), Aurora, Colorado, United States
St. Mary'S Hospital Regional Cancer Center, Grand Junction, Colorado, United States
Rocky mountain cancer centers LLP, Lakewood, Colorado, United States
Holy Cross Hospital- Bienes Cancer Center, Fort Lauderdale, Florida, United States
Memorial Healthcare System, Hollywood, Florida, United States
Orlando Health Inc., Orlando, Florida, United States
Ft. Wayne Medical Oncology and Hematology, Inc, Fort Wayne, Indiana, United States
New England Cancer Specialists, Scarborough, Maine, United States
Health Partners Institute Park Nicollet Frauenshuh Cancer Center, Saint Louis Park, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
New Jersey Hematology & Oncology Associates, Brick, New Jersey, United States
Northern Westchester Hospital Cancer Treatment & Wellness Center, Mount Kisco, New York, United States
Oregon Health and Science University, Portland, Oregon, United States
Texas Oncology, P.A., Austin, Texas, United States
Texas Oncology - Presbyterian Hospital, Dallas, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
Texas Oncology- South Second Street, McAllen, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Texas Oncology,PA. Tyler TX, 75702, Tyler, Texas, United States
Virginia Cancer Specialist PC, Leesburg, Virginia, United States
West Virginia University School of Medicine, Morgantown, West Virginia, United States
Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain
Onkologikoa, San Sebastian, Guipuzcoa, Spain
Hospital Universitari Son Espases, Palma de Mallorca, Islas Baleares, Spain
Hospital Son Llatzer, Palma de Mallorca, Islas Baleares, Spain
Hospital Universitario Puerta del Hierro, Majadahonda, Madrid, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Sant Joan de Reus, Reus, Tarragona, Spain
Complejo Hospitalario Universitario A Coruna, A Coruna, , Spain
Centro Oncologico de Galicia, A Coruna, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial, Barcelona, , Spain
Hospital De la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital San Pedro de Alcantara, Caceres, , Spain
Hospital Universitari Arnau de Vilanova de Lleida, Lleida, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital General Universitario Morales Messeguer, Murcia, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca, Murcia, , Spain
Hospital Universitario Virgen de la Macarena, Sevilla, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Medical Monitor
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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