Clinical Trials Search
Clinical Trial 19328
Interventions:Faslodex (fulvestrant); Not Applicable; Placebo; Seribantumab; fulvestrant
Study Type: Treatment
Phase of Study: Phase II
- Heather Han
SHERBOC: A Double-blind, Placebo-controlled, Phase 2 trial of Seribantumab Plus Fulvestrant in Postmenopausal Women with Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Systemic Therapy
The main purpose of this study is to learn whether cancer cell growth (disease progression) is delayed in people taking seribantumab and fulvestrant for the treatment of heregulin positive, hormone receptor positive metastatic breast cancer.
Primary Objective: To determine whether the combination of seribantumab + fulvestrant is more effective than placebo + fulvestrant based on investigator assessed Progression Free Survival (PFS) in HRG positive patients (defined as HRG ISH score of > 1+). Secondary Objectives: To determine whether the combination of seribantumab + fulvestrant is more effective than placebo + fulvestrant in HRG positive patients for the following clinical outcome parameters: Time to Progression (TTP). Overall Survival (OS). Objective Response Rate (ORR) based on RECISTv1.1. To describe the safety profile of seribantumab in combination with fulvestrant. To characterize the pharmacokinetic (PK) profile of seribantumab when given in combination with fulvestrant and of fulvestrant when given in combination with seribantumab. Exploratory Objectives: To assess the correlation for HRG expression between fresh tissue biopsies and archival samples where available.