NCT03241810

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

Randomized Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer (Merrimack Pharmaceuticals Inc.)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Elevation Oncology · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Seribantumab	Seribantumab is a human monoclonal antibody that inhibits ErbB3 signalling
DRUG	Fulvestrant	Fulvestrant is an estrogen receptor antagonist with no agonist effects
DRUG	Placebo	Placebo

Timeline

• Start date: 2017-08-15
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2017-08-08
• Last updated: 2020-09-02
• Results posted: 2020-09-02

Locations

59 sites across 6 countries: United States, Austria, Belgium, Canada, Germany, Spain

Regulatory

• FDA-regulated drug study