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
Public ClinicalTrials.gov record NCT02049957. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02049957
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 118 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 13, 2014 (Actual)
- Primary completion
- Jun 29, 2018 (Actual)
- Completion
- Jun 29, 2018 (Actual)
- Last update posted
- Feb 8, 2023
2014 – 2018
United States locations
- U.S. sites
- 30
- U.S. states
- 13
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles Hematology | Los Angeles | California | 90017 | — |
| University of California at San Francisco (PARENT) | San Francisco | California | 94143 | — |
| Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | 93105 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Centers, LLP | Lakewood | Colorado | 80228 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Florida Cancer Research Institute | Plantation | Florida | 33324 | — |
| University of Kansas Medical Center Research Institute, Inc. | Westwood | Kansas | 66205 | — |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | — |
| Henry Ford Medical Center | Novi | Michigan | 48322 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | — |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Weill Cornell Medical College New York Presbyterian Hospital | New York | New York | 10065 | — |
| Eastchester Center for Cancer Care / BRANY | The Bronx | New York | 10469 | — |
| University of Cincinnati Physicians Company, LLC | Cincinnati | Ohio | 45267-0502 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | — |
| Texas Oncology, P.A. - Beaumont | Beaumont | Texas | 77702-1449 | — |
| Texas Oncology, P.A. | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390-9085 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Millennium Oncology | Houston | Texas | 77090 | — |
| Texas Health Physicians Group | Plano | Texas | 75093 | — |
| Cancer Care Network of South Texas - SAT&BC | San Antonio | Texas | 78217 | — |
| Texas Oncology, P.A. - Tyler | Tyler | Texas | 75702 | — |
| Virginia Oncology Associates - Hampton | Chesapeake | Virginia | 23320 | — |
| Oncology and Hematology Assoc. of SW VA, Inc. | Salem | Virginia | 24153 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02049957, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02049957 live on ClinicalTrials.gov.