Clinical Trial: A Study of Anti-PD-1 (Pembrolizumab) + Hormonal Therapy in HR-positive Localized IBC Patients With Non-pCR to Neoadjuvant Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Hormonal Therapy in Patients With Hormone Receptor (HR)-Positive Localized Inflammatory Breast Cancer (IB

Brief Summary: The goal of this clinical research study is to learn if pembrolizumab in combination with standard hormone therapy can help to control and prevent IBC. The safety of this drug combination will also be studied.

Detailed Summary:

Study Drug Administration:

If participant is found to be eligible to take part in this study, participant will receive pembrolizumab by vein over about 30 minutes on Day 1 (+/- 3 days) of each 21-day cycle.

Participant will also receive hormonal therapy that participant's doctor has chosen for participant's standard treatment. The study doctor will tell participant which hormonal therapy participant receives, its risks, and how often participant will receive it.

Length of Study:

Participant may continue taking the study drug for up to 24 months, as long as the doctor thinks it is in participant's best interest. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Participation on the study will be over after the follow-up visits (described below).

Study Visits:

On Day 1 of each cycle:

  • Participant will have a physical exam
  • Blood (about 2 tablespoons) will be drawn for routine tests.

At Cycle 4 and then every 3 cycles after that (before Cycle 4, 7, 10, 13 and so on), participant will have imaging scans, including an EKG and either an ECHO or MUGA scan, to check the status of the disease as part of participant's standard care. Also, blood (about 7 tablespoons) will be drawn for biomarker and immune system testing. This blood will also be drawn if the disease appears to get worse. Participa
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Disease-free survival (DFS) [ Time Frame: Up to 24 months ]

Disease-free survival (DFS) as evidenced by the participant remaining alive with continued disease control. Disease progression status follow up: 24 months after the first treatment of the study regimen for participants who were taken off study treatment for reasons other than disease progression.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: November 21, 2016
Date Started: January 26, 2017
Date Completion: January 1, 2020
Last Updated: April 20, 2017
Last Verified: April 2017