CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 30 enrolled
Drug / intervention
Capecitabine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03044730
NCT03044730Phase 2Unknown

Phase II Study of Pembrolizumab and Capecitabine for Advanced Triple Negative and Hormone-Refractory Breast Cancer

Northwestern University·interventional·Posted Feb 7, 2017·Updated Jul 13, 2020

In Brief

A Phase 2 clinical trial evaluating Capecitabine, Laboratory Biomarker Analysis, and 1 other intervention for Estrogen Receptor Negative and 9 related conditions. Targeting 30 participants across 2 sites.

Detailed Summary

The purpose of this study is to see whether a combination of two different drugs - pembrolizumab and capecitabine - is safe, and if it might be effective in treating triple negative and hormone-refractory breast cancer. Pembrolizumab is a type of drug that contains an antibody. Antibodies are the part of your immune system that finds things that don't belong in your body, such as bacteria or viruses. The antibody in pembrolizumab finds and blocks a protein, which allows your immune system to target and destroy cancer cells. Pembrolizumab is Food and Drug Administration (FDA) approved for other types of cancer. It is not approved for breast cancer, meaning that it is an "experimental" or "investigational" treatment. Capecitabine is a type of chemotherapy pill that is a standard treatment and FDA-approved for breast cancer. It stops the cancer cells from being able to multiply.

Study Details

Timeline

Phase 2UnknownOverdue
2017201820192020202120222023202420252026
First PostedFeb 7, 2017
Enrollment StartMay 25, 2017
Primary CompletionApr 24, 2019
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.4 years ago

Interventions

Capecitabinedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pembrolizumabbiological

Given IV