NCT03644589

Effect of Pembrolizumab and Cisplatin on Metastatic, Locally Recurrent or Inoperable Triple-Negative Breast Cancer

A Phase II Trial Evaluating Safety and Efficacy of Pembrolizumab and Cisplatin in Patients With Advanced Triple Negative Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II treatment study that is done to evaluate how effective and safe the combination of pembrolizumab and cisplatin work in treating participants with triple-negative breast cancer that had spread to other parts of the body, has come back, or cannot be removed by surgery. Pembrolizumab (investigational drug) is a monoclonal antibody that works by helping your immune system to fight cancer. Cisplatin is a chemotherapy drug that works by interfering with tumor cell division. Studies also suggest that treatment with chemotherapy, like cisplatin, may improve the effectiveness of pembrolizumab. This study will test the effectiveness of pembrolizumab and cisplatin in participants with advanced triple-negative breast cancer.

Detailed description

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.

Conditions

• Estrogen Receptor Negative
• HER2/Neu Negative
• Metastatic Breast Cancer
• Progesterone Receptor Negative
• Recurrent Breast Carcinoma
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	200mg,Given intravenous (IV) infusion, every 21 days
DRUG	Cisplatin	75mg/m2, intravenous (IV) infusion, every 21 days, for 6 cycles Given IV

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-10-30
• Completion: 2022-10-30
• First posted: 2018-08-23
• Last updated: 2019-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study