Study on Pembrolizumab and Decitabine Before Standard Chemotherapy for Locally Advanced HER2-Negative Breast Cancer
Sponsor: Virginia Commonwealth University
ClinicalTrials ID:NCT02957968
This clinical trial is testing a new treatment approach for patients with locally advanced HER2-negative breast cancer. It involves using two drugs, pembrolizumab and decitabine, before starting the usual chemotherapy to see if they can increase the immune response against the cancer.
Patient Parameters
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Program Overview
This study is exploring whether a short course of immunotherapy, using the drugs decitabine and pembrolizumab, can enhance the immune system's response to breast cancer before starting standard chemotherapy. The trial involves two groups of patients based on their hormone receptor status: one group with hormone receptor-negative breast cancer and another with hormone receptor-positive breast cancer. The main goal is to see if this treatment increases the number of immune cells in the tumor area before chemotherapy begins.
Description
In this study, all participants will receive the same doses and schedule of decitabine and pembrolizumab, followed by standard chemotherapy. This includes four cycles of AC (a combination of chemotherapy drugs) and 12 weekly doses of paclitaxel or Nab-paclitaxel. For some patients, paclitaxel or Nab-paclitaxel will be combined with carboplatin. The order of these treatments will be decided by the treating doctor. The study will evaluate the primary outcome by looking at the results from patients with hormone receptor-negative breast cancer together, separate from those with hormone receptor-positive breast cancer.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with invasive breast cancer through a biopsy.
- Breast cancer must be HER2-negative based on specific medical guidelines.
- Breast cancer must be either hormone receptor-positive or hormone receptor-negative.
- Cancer must be locally advanced, meeting certain size and lymph node criteria.
- Must have imaging of the breast and lymph nodes within a specified time before joining the study.
- Must be 18 years or older.
- Must be in good overall health with a performance status of 0 or 1.
- Must have adequate blood cell counts and organ function based on specific tests.
- Women who are not postmenopausal or have not had a hysterectomy must have a negative pregnancy test before starting treatment.
- Must agree to use effective birth control during and after treatment if of childbearing potential.
Exclusion Criteria
- Have received any treatment for the current breast cancer diagnosis before joining the study.
- Have received a live vaccine within 30 days before starting treatment.
- Have received a monoclonal antibody or investigational agent recently.
- Have extensive metastatic disease that prevents surgery.
- Have a history of certain types of breast cancer or other cancers.
- Have certain heart conditions or nerve disorders.
- Are taking systemic steroids or immunosuppressive therapy recently.
- Have a known allergy to the study drugs.
- Have an active infection or certain viral infections.
- Are pregnant or breastfeeding.
- Have been treated for another cancer within the last 5 years, with some exceptions.
- Have any condition that may increase risk or affect adherence to the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| St. Elizabeth Healthcare | 41017 | Edgewood | Kentucky |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| University of Virginia | 22903 | Charlottesville | Virginia |
| Virginia Commonwealth University/Massey Cancer Center | 23298 | Richmond | Virginia |
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