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Completed Phase 2 Interventional Results available

Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy

ClinicalTrials.gov ID: NCT02756364

Public ClinicalTrials.gov record NCT02756364. 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.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02756364
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Calithera Biosciences, Inc
Industry
Enrollment
141 participants

Conditions and interventions

Interventions

Drug

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
Jul 28, 2016 (Actual)
Primary completion
Nov 25, 2019 (Actual)
Completion
Nov 25, 2019 (Actual)
Last update posted
Feb 8, 2023

2016 – 2019

United States locations

U.S. sites
30
U.S. states
14
U.S. cities
29
Facility City State ZIP Site status
Southern Cancer Center, PC Mobile Alabama 36608 —
CBCC Global Research 6501 Truxtun Avenue Bakersfield, CA Bakersfield California 93309 —
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare Fullerton California 92835 —
UCSD Moores Cancer Center La Jolla California 92037 —
UCLA Hematology/Oncology David Geffen School of Medicine Los Angeles California 90095-7077 —
North County Oncology Oceanside California 92056 —
Torrance Health Association Redondo Beach California 90277 —
PHC-SLO Oncology and Hematology San Luis Obispo California 93401 —
Cancer Center of Santa Barbara With Sansum Clinic Santa Barbara California 93105 —
University of Colorado Cancer Center-Anschutz Cancer Pavilion (ACP) Aurora Colorado 80045 —
St. Mary'S Hospital Regional Cancer Center Grand Junction Colorado 81501 —
Rocky mountain cancer centers LLP Lakewood Colorado 80228 —
Holy Cross Hospital- Bienes Cancer Center Fort Lauderdale Florida 33308 —
Memorial Healthcare System Hollywood Florida 33021 —
Orlando Health Inc. Orlando Florida 33806 —
Ft. Wayne Medical Oncology and Hematology, Inc Fort Wayne Indiana 46804 —
New England Cancer Specialists Scarborough Maine 04074 —
Health Partners Institute Park Nicollet Frauenshuh Cancer Center Saint Louis Park Minnesota 55426 —
Comprehensive Cancer Centers of Nevada Henderson Nevada 89074 —
New Jersey Hematology & Oncology Associates Brick New Jersey 8724 —
Northern Westchester Hospital Cancer Treatment & Wellness Center Mount Kisco New York 10549 —
Oregon Health and Science University Portland Oregon 97239 —
Texas Oncology, P.A. Austin Texas 78745 —
Texas Oncology - Presbyterian Hospital Dallas Texas 75231 —
Texas Oncology, P.A. Dallas Texas 75246 —
Texas Oncology- South Second Street McAllen Texas 78503 —
Cancer Care Centers of South Texas San Antonio Texas 78217 —
Texas Oncology,PA. Tyler TX, 75702 Tyler Texas 75702 —
Virginia Cancer Specialist PC Leesburg Virginia 20176 —
West Virginia University School of Medicine Morgantown West Virginia 26505 —

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 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02756364, 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 NCT02756364 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →