A Study of Anti-PD-1 (Pembrolizumab) + Hormonal Therapy in HR-positive Localized IBC Patients With Non-pCR to Neoadjuvant Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02971748|
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : August 1, 2018
You are being asked to take part in this study because you have inflammatory breast cancer (IBC) that did not respond completely to chemotherapy.
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.
This is an investigational study. Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma. Its use in patients with IBC in combination with standard hormonal therapy is considered investigational.
The study doctor can explain how the study drugs are designed to work.
Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Breast Cancer Malignant Neoplasm of Breast||Drug: Pembrolizumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 (IBC) Who Did Not Achieve a Pathological Complete Response (pCR) to Neoadjuvant Chemotherapy|
|Actual Study Start Date :||January 26, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
200 mg on day 1 of each 3-week cycle as 30 minute intravenous (IV) infusion
Pembrolizumab 200 mg administered on day 1 of each 3-week cycle as approximately 30 minute IV infusion. Hormonal therapy at physicians' discretion including tamoxifen, exemestane, anastrozole, letrozole, LHRH agonist and combination with any of above and starts at the same time as pembrolizumab.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971748
|Contact: Bora Lim, MDfirstname.lastname@example.org|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: MD Anderson Health Information Specialist 877-632-6789|
|Contact: Breast Medical Oncology 713-792-2817|
|Study Chair:||Bora Lim, MD||The University of Texas MD Anderson Cancer Center|