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

NCT03644589 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-04-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jennifer Specht, MD · Associate Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-10-30
Completion
2022-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03644589 on ClinicalTrials.gov