Pembrolizumab and Capecitabine in Treating Patients With Locally Advanced or Metastatic Triple Negative or Hormone-Refractory Breast Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT03044730|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Recurrent Breast Carcinoma Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Triple-Negative Breast Carcinoma||Drug: Capecitabine Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To evaluate the median progression-free survival (median PFS) for participants receiving pembrolizumab with capecitabine for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC) and hormone-refractory metastatic breast cancer (MBC).
I. To describe the objective response rate (ORR) for participants receiving pembrolizumab with capecitabine for the treatment of locally advanced or metastatic TNBC and hormone-refractory MBC.
II. To describe the safety and tolerability of the combination of pembrolizumab and capecitabine for the treatment of locally advanced or metastatic TNBC and hormone-refractory MBC.
I. Analysis of expression of programmed cell death 1 ligand 1 (PD-L1) through immunohistochemical (IHC) analysis.
II. To assess circulating tumor DNA (ctDNA). III. To evaluate ORR and median-PFS using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).
Patients receive pembrolizumab intravenously (IV) on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab and Capecitabine for Advanced Triple Negative and Hormone-Refractory Breast Cancer|
|Actual Study Start Date :||May 25, 2017|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Treatment (pembrolizumab, capecitabine)
Patients receive pembrolizumab IV on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Median PFS (median Progression-Free Survival) [ Time Frame: Up to 2 years ]Evaluate the median PFS for participants receiving pembrolizumab with capecitabine for the treatment of locally advanced or metastatic TNBC and hormone-refractory MBC. Assessment will be done using irRECIST.
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]ORR will be assessed with imaging scans and use RECIST 1.1 criteria.
- Incidence of Adverse Events [ Time Frame: Up to 2 years ]Determine the safety and tolerability of the combination of pembrolizumab and Capecitabine by evaluating the incidence of adverse events. All adverse events will be assessed using the National Cancer Institute Common Terminology Criteria 4.03 criteria (NCI CTCAE 4.03 criteria).
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): NCT03044730
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Northwestern Lake Forest Hospital|
|Lake Forest, Illinois, United States, 60045|
|Principal Investigator:||Sarika Jain, MD||Northwestern University|