Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)
18 Years and older, Male and Female
3475-355 (primary)
NCI-2016-01555
163422
2016-001432-35
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 background chemotherapy will be
assessed compared to the safety and efficacy of placebo plus background chemotherapy in the
treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously
treated with chemotherapy.
The primary hypotheses are that:
1. the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival
(PFS) compared to placebo and chemotherapy in:
- all participants,
- participants with programmed cell death-ligand 1 (PD-L1) combined positive score
(CPS) =1 tumors, and
- participants with PD-L1 CPS =10 tumors, and
2. the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS)
compared to placebo and chemotherapy in:
- all participants,
- participants with PD-L1 CPS =1 tumors, and
- participants with PD-L1 CPS =10 tumors.
Eligibility
- Has locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.
- Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines.
- Has completed treatment for Stage I-III breast cancer, if indicated, and =6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
- Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by local radiology review.
- Has provided recently or newly obtained core or excisional biopsy from a locally recurrent inoperable or metastatic tumor lesion for central determination of TNBC status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or participant safety concerns.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to the start of study drug.
- Has a life expectancy =12 weeks from randomization.
- Demonstrates adequate organ function, within 10 days prior to the start of study drug.
- Female participants are eligible to participate if they are not pregnant or breastfeeding AND they are not a woman of childbearing potential (WOCBP) OR is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention AND has a negative highly-sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours (urine) or 72 hours (serum) before the first dose of study intervention.
- Male participants are eligible to participate if they agree to refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention PLUS be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic.
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