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A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCT ID
NCT02819518
Protocol IDs
3475-355 (primary)
NCI-2016-01555
163422
2016-001432-35
Study Sponsor
Merck and Company Inc

Summary

The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in

combination with one of three different chemotherapies will be assessed in the treatment of

locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has

not been previously treated with chemotherapy. In Part 2, the safety and efficacy of

pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of

placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic

TNBC, which has not been previously treated with chemotherapy.

The primary hypotheses are that the combination of pembrolizumab and chemotherapy prolongs

Progression-Free Survival (PFS) compared to placebo and chemotherapy in all participants and

in participants with programmed cell death ligand 1 (PD-L1) positive tumors, and prolongs

Overall Survival (OS) compared to placebo and chemotherapy in all participants and in

participants with PD-L1 positive tumors.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.