Last updated on September 2018

Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer

Brief description of study

This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer.

Detailed Study Description

This study is a randomized, double-blind, placebo-controlled international phase 2 trial in patients with HRG+, HR+, HER2- metastatic breast cancer that has progressed following treatment with no more than 2 prior therapies, one of which must have been a CDK inhibitor. All patients will be screened for heregulin using central testing, and eligible patients will be randomized to receive either seribantumab + fulvestrant or placebo + fulvestrant. Disease status will be assessed according to RECIST v 1.1 to support the primary endpoint.

Clinical Study Identifier: NCT03241810

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Beverly Hills Cancer Center

Beverly Hills, CA United States
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Moffitt Cancer Center

Tampa, FL United States
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Highland Oncology Group

Fayetteville, AR United States
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University of Mississippi

Jackson, MS United States
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Lahey Clinical Medical Center

Burlington, MA United States
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UPMC Cancer Center

Pittsburgh, PA United States
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Mercy Hospital Springfield

Springfield, MO United States
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Holy Cross Hospital Health Center

Silver Spring, MD United States
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Saint Helena Hospital

Saint Helena, CA United States
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Stanford University

Palo Alto, CA United States
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Stamford Hospital

Stamford, CT United States
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Hospital Son Llatzer

Palma de Mallorca, Spain
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