Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive,

NCT number	NCT03393845
Study type	Interventional
Source	Big Ten Cancer Research Consortium
Contact	Nancy Chan, MD
Phone	1 732-235-9692
Email	cheungna@cinj.rutgers.edu
Status	Recruiting
Phase	Phase 2
Start date	January 29, 2018
Completion date	January 1, 2022

View Details

Status Recruiting

Clinical Trial Summary

Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients

Clinical Trial Description

This is a non-randomized, multi-site, open-label Phase II trial for subjects with metastatic, hormone receptor positive, HER2 negative breast cancer. The study will enroll 47 patients to evaluate the anti-tumor activity of pembrolizumab with fulvestrant as measured by RECIST 1.1 tumor response and by progression free survival. We expect that if the immune response is augmented by the addition of pembrolizumab, significant change in durability of response will be noted.

Patients will be treated with pembrolizumab dosed at 200 mg intravenous infusion in combination with standard fulvestrant 500mg intramuscular injection.

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms