Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior 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: NCT02411656|
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Edema Erythema Estrogen Receptor Negative HER2/Neu Negative Peau d'Orange Progesterone Receptor Negative Recurrent Inflammatory Breast Carcinoma Stage IV Inflammatory Breast Carcinoma Triple-Negative Breast Carcinoma||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To assess the efficacy of pembrolizumab (MK-3475) as a single agent in patients with metastatic inflammatory breast cancer (IBC) and non-IBC triple-negative breast cancer (TNBC).
I. To investigate the association between biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC or non-IBC TNBC patients treated with MK-3475.
II. To determine the disease control rate of metastatic IBC or non-IBC TNBC patients who have achieved clinical response or stable disease to the systemic therapy.
III. To investigate the association between biomarkers and efficacy by ribonucleic acid (RNA)-sequencing of exosomes in blood and tumor for IBC or non-IBC TNBC patients.
Patients receive pembrolizumab intravenously (IV) over approximately 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at approximately 1 and 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer (IBC) or Non-IBC Triple Negative Breast Cancer (TNBC) Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy|
|Actual Study Start Date :||June 11, 2015|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over approximately 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Rate of disease control [ Time Frame: Up to 3 months post-treatment ]Defined as the percentage of patients either with measurable disease that maintain immune complete response (iCR), immune partial response, immune stable disease (iSD), or with non-measurable disease that achieve iCR or iSD, by 4 months or more in all evaluable patients. A disease control rate of 10% or lower will be considered treatment failure and the regimen will be rejected under this circumstance. A 95% exact binomial confidence interval on disease control rate will be computed. Will also perform secondary analysis on intent-to-treat patient population where those patients who drop out early will be considered as progression.
- Biomarker analyses [ Time Frame: Baseline ]Correlation among biomarkers at baseline in each specimen and between different specimens will be assessed. The association among various continuous and discrete biomarkers or disease status groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc, and may be tested by t-test/analysis of variance/Wilcoxon rank sun test/Kruskal-Wallis test, whichever is appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients.
- Disease control survival [ Time Frame: Up to 3 months post-treatment ]Estimated using Kaplan-Meier method.
- Overall survival time [ Time Frame: Up to 3 months post-treatment ]Estimated using Kaplan-Meier method.
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): NCT02411656
|Contact: Naoto Uenoemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Naoto T. Ueno 713-792-2817|
|Principal Investigator: Naoto T. Ueno|
|Principal Investigator:||Bora Lim||M.D. Anderson Cancer Center|