Last updated on May 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

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Takeda Study Registration Call Center

Hospital Universitario Puerta del Hierro
Majadahonda, Spain
0.66miles
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Takeda Study Registration Call Center

Hospital Clinico San Carlos
Madrid, Spain
7.07miles
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Takeda Study Registration Call Center

Hospital Universitario Ramon y Cajal
Madrid, Spain
9.66miles
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