Last updated on December 2018

MLN0128 in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy


Brief description of study

The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily MLN0128 and fulvestrant plus weekly MLN0128 versus participants treated with single-agent fulvestrant.

Detailed Study Description

The drug being tested in this study is called MLN0128. MLN0128 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 MLN0128 and fulvestrant + weekly MLN0128 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 groupswhich 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 + MLN0128 4 mg
  • Fulvestrant 500 mg + MLN0128 30 mg

All participants will receive either fulvestrant 500 mg intramuscularly (IM), fulvestrant 500 mg + MLN0128 4 mg daily or fulvestrant 500 mg + MLN0128 30 mg weekly.

This multicenter trial will be conducted worldwide. 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).

Clinical Study Identifier: NCT02756364

Contact Investigators or Research Sites near you

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Takeda Study Registration Call Center

Southern Cancer Center, PC
Mobile, AL United States

Takeda Study Registration Call Center

Arizona Oncology Associates, PC, NAHOA
Sedona, AZ United States

Takeda Study Registration Call Center

Arizona Oncology Associates, PC- HOPE
Tucson, AZ United States

Takeda Study Registration Call Center

CBCC Global Research 6501 Truxtun Avenue Bakersfield, CA
Bakersfield, CA United States

Takeda Study Registration Call Center

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, CA United States

Takeda Study Registration Call Center

UCSD Moores Cancer Center
La Jolla, CA United States

Takeda Study Registration Call Center

UCLA Hematology/Oncology David Geffen School of Medicine
Los Angeles, CA United States

Takeda Study Registration Call Center

North County Oncology
Oceanside, CA United States

Takeda Study Registration Call Center

Torrance Health Association
Redondo Beach, CA United States

Takeda Study Registration Call Center

PHC-SLO Oncology and Hematology
San Luis Obispo, CA United States

Takeda Study Registration Call Center

Cancer Center of Santa Barbara With Sansum Clinic
Santa Barbara, CA United States

Takeda Study Registration Call Center

University of Colorado Cancer Center-Anschutz Cancer Pavilion (ACP)
Aurora, CO United States

Takeda Study Registration Call Center

St. Mary'S Hospital Regional Cancer Center
Grand Junction, CO United States

Takeda Study Registration Call Center

Rocky mountain cancer centers LLP
Lakewood, CO United States

Takeda Study Registration Call Center

Holy Cross Hospital- Bienes Cancer Center
Fort Lauderdale, FL United States

Takeda Study Registration Call Center

Memorial Healthcare System
Hollywood, FL United States

Takeda Study Registration Call Center

Ocala Oncology Center, PL d/b/a Florida Cancer Affiliates- Florida
Ocala, FL United States

Takeda Study Registration Call Center

Orlando Health Inc.
Orlando, FL United States

Takeda Study Registration Call Center

Rush University Medical Center
Chicago, IL United States

Takeda Study Registration Call Center

Ft. Wayne Medical Oncology and Hematology, Inc
Fort Wayne, IN United States

Takeda Study Registration Call Center

New England Cancer Specialists
Scarborough, ME United States

Takeda Study Registration Call Center

University of Minnesota Medical Center Mayo B405
Minneapolis, MN United States

Takeda Study Registration Call Center

Health Partners Institute Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, MN United States

Takeda Study Registration Call Center

Comprehensive Cancer Centers of Nevada
Henderson, NV United States

Takeda Study Registration Call Center

New Jersey Hematology & Oncology Associates
Brick, NJ United States

Takeda Study Registration Call Center

Northern Westchester Hospital Cancer Treatment & Wellness Center
Mount Kisco, NY United States

Takeda Study Registration Call Center

Oncology/Hemaotlogy care clinical trials, LLC
Cincinnati, OH United States

Takeda Study Registration Call Center

Hematology Oncology Associate, PC (Medford, OR)
Medford, OR United States

Takeda Study Registration Call Center

Oregon Health and Science University
Portland, OR United States

Takeda Study Registration Call Center

Texas Oncology, P.A.
Austin, TX United States

Takeda Study Registration Call Center

Texas Oncology, PA
Bedford, TX United States

Takeda Study Registration Call Center

Texas Oncology - Presbyterian Hospital
Dallas, TX United States

Takeda Study Registration Call Center

Texas Oncology, P.A.
Dallas, TX United States

Takeda Study Registration Call Center

Texas Oncology , PA
El Paso, TX United States

Takeda Study Registration Call Center

Texas Oncology- South Second Street
McAllen, TX United States

Takeda Study Registration Call Center

Cancer Care Centers of South Texas
San Antonio, TX United States

Takeda Study Registration Call Center

Texas Oncology,PA. Tyler TX, 75702
Tyler, TX United States

Takeda Study Registration Call Center

Virginia Cancer Specialist PC
Leesburg, VA United States

Takeda Study Registration Call Center

West Virginia University School of Medicine
Morgantown, WV United States

Takeda Study Registration Call Center

Columbia St. Marys
Milwaukee, WI United States

Takeda Study Registration Call Center

Consorci Sanitari de Terrassa
Terrassa, Spain

Takeda Study Registration Call Center

Onkologikoa
San Sebastian, Spain

Takeda Study Registration Call Center

Hospital Universitari Son Espases
Palma de Mallorca, Spain

Takeda Study Registration Call Center

Hospital Son Llatzer
Palma de Mallorca, Spain

Takeda Study Registration Call Center

Hospital Universitario Puerta del Hierro
Majadahonda, Spain

Takeda Study Registration Call Center

Clinica Universidad de Navarra
Pamplona, Spain

Takeda Study Registration Call Center

Hospital Universitario Sant Joan de Reus
Reus, Spain

Takeda Study Registration Call Center

Complejo Hospitalario Universitario A Coruna
A Coruna, Spain

Takeda Study Registration Call Center

Centro Oncologico de Galicia
A Coruna, Spain

Takeda Study Registration Call Center

Hospital Universitari Vall d'Hebron
Barcelona, Spain

Takeda Study Registration Call Center

Hospital Clinic i Provincial
Barcelona, Spain

Takeda Study Registration Call Center

Hospital De la Santa Creu i Sant Pau
Barcelona, Spain

Takeda Study Registration Call Center

Hospital San Pedro de Alcantara
Caceres, Spain

Takeda Study Registration Call Center

Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain

Takeda Study Registration Call Center

Hospital General Universitario Gregorio Maranon
Madrid, Spain

Takeda Study Registration Call Center

Hospital Universitario Ramon y Cajal
Madrid, Spain

Takeda Study Registration Call Center

Hospital Clinico San Carlos
Madrid, Spain

Takeda Study Registration Call Center

Hospital General Universitario Morales Messeguer
Murcia, Spain

Takeda Study Registration Call Center

Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Spain

Takeda Study Registration Call Center

Hospital Universitario Virgen de la Macarena
Sevilla, Spain

Takeda Study Registration Call Center

Fundacion Instituto Valenciano de Oncologia
Valencia, Spain

Takeda Study Registration Call Center

Hospital Clinico Universitario de Valencia
Valencia, Spain

Takeda Study Registration Call Center

Hospital Universitari Arnau de Vilanova de Valencia
Valencia, Spain

Takeda Study Registration Call Center

Hospital Universitario Miguel Servet
Zaragoza, Spain

Recruitment Status: Closed


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