Spots Global Cancer Trial Database for Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer
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Trial Identification
Brief Title: Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer
Official Title: A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant
Study ID: NCT02049957
Conditions
Study Description
Brief Summary: This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant.
Detailed Description: The drug being tested in this study is called sapanisertib (MLN0128). Sapanisertib is being tested in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus. This study will look at the safety and efficacy of sapanisertib when given in combination with exemestane or fulvestrant. The study enrolled 118 patients. This study has two phases: phase 1 and phase 2. Phase 1 has 2 parts. In part 1 of phase 1, unmilled active pharmaceutical ingredient (API) capsules were administered, while in part 2, capsules based on milled API were administered. * Phase 1 (Part 1): sapanisertib 5 mg (unmilled) + exemestane * Phase 1 (Part 1): sapanisertib 5 mg (unmilled) + fulvestrant * Phase 1 (Part 2): sapanisertib 3 mg (milled) + exemestane * Phase 1 (Part 2): sapanisertib 3 mg (milled) + fulvestrant * Phase 1 (Part 2): sapanisertib 4 mg (milled) + exemestane In phase 2, participants were enrolled into one of 2 parallel cohorts, depending on the quality and/or duration of their prior response to everolimus in combination with either exemestane (any country) or fulvestrant (US only). Everolimus-Resistant Cohort: patients who had progressed on treatment with everolimus in combination with either exemestane (any country) or fulvestrant (US only) without achieving an objective response (CR or PR) or after achieving stable disease for \<6 months as their best response. Everolimus-Sensitive Cohort: participants who had progressed on treatment after achieving a CR or PR of any duration, or stable disease for ≥6 months with prior everolimus treatment in combination with either exemestane (any country) or fulvestrant (US only). Participants were to receive MLN0128 in combination with the same dose of the previously administered treatment (exemestane \[any country\] or fulvestrant \[US only\]). This multi-center trial will be conducted worldwide. The overall time to participate in this study was 52 months. Participants made multiple visits to the clinic and were contacted by telephone every 3 months for a follow-up assessment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Los Angeles Hematology, Los Angeles, California, United States
University of California at San Francisco (PARENT), San Francisco, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, LLP, Lakewood, Colorado, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Florida Cancer Research Institute, Plantation, Florida, United States
University of Kansas Medical Center Research Institute, Inc., Westwood, Kansas, United States
Holy Cross Hospital, Silver Spring, Maryland, United States
Henry Ford Medical Center, Novi, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Eastchester Center for Cancer Care / BRANY, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Weill Cornell Medical College New York Presbyterian Hospital, New York, New York, United States
University of Cincinnati Physicians Company, LLC, Cincinnati, Ohio, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Erlanger Medical Center, Chattanooga, Tennessee, United States
Texas Oncology, P.A. - Beaumont, Beaumont, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Millennium Oncology, Houston, Texas, United States
Texas Health Physicians Group, Plano, Texas, United States
Cancer Care Network of South Texas - SAT&BC, San Antonio, Texas, United States
Texas Oncology, P.A. - Tyler, Tyler, Texas, United States
Virginia Oncology Associates - Hampton, Chesapeake, Virginia, United States
Oncology and Hematology Assoc. of SW VA, Inc., Salem, Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
UZ Antwerpen, Antwerpen, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
Universitair Ziekenhuis Brussel, Bruxelles, , Belgium
GHdC Notre Dame, Charleroi, , Belgium
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus, Wilrijk, , Belgium
Centre Francois Baclesse, Caen Cedex 05, Calvados, France
Centre Catherine de Sienne, Nantes, Loire Atlantique, France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans Cedex 02, Sarthe, France
Institut Sainte Catherine, Avignon, Vaculuse, France
Contact Details
Name: Medical Monitor
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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