Effect of Pembrolizumab and Cisplatin on Metastatic, Locally Recurrent or Inoperable Triple-Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03644589|
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor Negative HER2/Neu Negative Metastatic Breast Cancer Progesterone Receptor Negative Recurrent Breast Carcinoma Triple Negative Breast Cancer||Biological: Pembrolizumab Drug: Cisplatin||Phase 2|
Participants will receive pembrolizumab intravenously (IV) over 30 minutes and cisplatin once every 3 weeks for a total of 6 doses. Both drugs are given by vein (Intravenous(IV)) on day 1. Participants that are responding to the study treatment will continue to receive pembrolizumab alone for up to 24 months until disease gets worse, having bad side effects, no longer wish to be in the study, or have become pregnant (whichever comes first).
In addition to study drug administration visits, participants will be asked to have physical exams, blood draws every three weeks and tumor evaluation using MRI or CT scans every 9 weeks.
After completion of study treatment, participants are followed up for safety within at 30 days of last dose of study treatment and then every 12 weeks until study completion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Evaluating Safety and Efficacy of Pembrolizumab and Cisplatin in Patients With Advanced Triple Negative Breast Cancer|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||October 30, 2021|
|Estimated Study Completion Date :||October 30, 2022|
Experimental: Treatment (pembrolizumab, cisplatin)
Participants receive pembrolizumab and cisplatin once every 3 weeks for a total of 6 doses. Both drugs are given by vein (IV). Participants that are responding to the study treatment will continue to receive pembrolizumab alone beyond 6 cycles for up to 24 months until disease gets worse, having bad side effects, no longer wish to be in the study, or have become pregnant (whichever comes first).
Participants receive pembrolizumab over 30 minutes and cisplatin on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Participants without disease progression after 6 courses may continue on pembrolizumab IV on day 1 every 21 days for up to 24 months (or 35 courses) in the absence of disease progression or unacceptable toxicity.
200mg,Given intravenous (IV) infusion, every 21 days
75mg/m2, intravenous (IV) infusion, every 21 days, for 6 cycles Given IV
Other Name: CDDP
- To evaluate the efficacy of combination pembrolizumab and cisplatin in participants with advanced TNBC [ Time Frame: Up to 10 years ]Measured by overall response rate (ORR) assessed by RECIST v1.1 criteria.
- Safety of pembrolizumab and cisplatin in participants with advanced TNBC [ Time Frame: Up to 10 years ]Safety will be assessed by quantifying the toxicities and grades experienced by participants who have received pembrolizumab and cisplatin with summary statistics provided.
- Disease Control Rate [ Time Frame: Up to 10 years ]Measured by RECIST and irRECIST
- Disease control rate (DCR) [ Time Frame: Up to 10 years ]Measured by RECIST 1.1 and irRECIST.
- Duration of response (DoR) [ Time Frame: Up to 10 years ]Measured by RECIST 1.1 and irRECIST
- Progression-free survival [ Time Frame: Up to 10 years ]Measured by RECIST 1.1 and irRECIST criteria
- Overall survival (OS) in participants with advanced TNBC treated with pembrolizumab and cisplatin [ Time Frame: Up to 10 years ]
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): NCT03644589
|Contact: Jennifer Specht, MDfirstname.lastname@example.org|
|United States, Washington|
|Seattle Cancer Care Alliance, Fred Hutch/University of Washington Cancer Consortium||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Jennifer Specht, MD|
|Principal Investigator:||Jennifer Specht, MD||Associate Professor|