- 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
- 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 of childbearing potential must be willing to use an adequate
method of contraception for the course of the study through 120 days (or longer as
specified by local institutional guidelines) after the last dose of study drug.
- Male participants of childbearing potential must agree to use an adequate method of
contraception starting with the first dose of study drug through 120 days (or longer
as specified by local institutional guidelines) after the last dose of study drug.
- Is currently participating in a clinical study and receiving an investigational agent
and/or using an investigational device, or has participated in a clinical study and
received an investigational agent and/or used an investigational device within 4 weeks
prior to randomization.
- Has not recovered (e.g., to ≤ Grade 1 or to baseline) from AEs due to a previously
- Has neuropathy ≥ Grade 2.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years (e.g., with use of disease modifying agents, corticosteroids, or
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to randomization.
- Has a known additional malignancy that progressed or required active treatment within
the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell
carcinoma of the skin that has undergone potentially curative therapy, and in situ
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Participants with previously treated brain metastases may participate
provided they have stable brain metastases and did not receive chemotherapy for
metastatic breast cancer.
- Has history of (non-infectious) pneumonitis that required steroids or current
- Has active, or a history of, interstitial lung disease.
- Has a known history of active tuberculosis (TB).
- Has an active infection requiring systemic therapy.
- Has a history of Class II-IV congestive heart failure or myocardial infarction within
6 months of randomization.
- Has a known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
(or longer as specified by local institutional guidelines) after the last dose of
- Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1),
anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T
cell receptor (such as cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40,
CD137) or has previously participated in Merck pembrolizumab (MK-3475) clinical
- Has a known history of human immunodeficiency virus (HIV).
- Has known active hepatitis B or hepatitis C.
- Has received a live vaccine within 30 days prior to randomization.
- Has a known history of hypersensitivity or allergy to pembrolizumab and any of its
components and/or to any of the study chemotherapies (e.g., nab-paclitaxel,
paclitaxel, gemcitabine, or carboplatin) and any of their components.
- Is receiving any medication prohibited in combination with study chemotherapies as
described in the respective product labels, unless medication was stopped within 7
days prior to randomization.