Overview
A Phase II study that evaluating the efficacy and safety of pembrolizumab in combination with chemotherapy as neoadjuvant therapy for triple-negative breast cancer in the Chinese population
Eligibility
Inclusion Criteria:
Men or women who are 18 years of age or older on the date of signing the informed consent
form.
Pathologically confirmed invasive ductal carcinoma of the breast with stage T1c and N 1-3,
or cT2-T4/N0-3.
Patients with triple-negative breast cancer according to the most recent American Society
of Clinical Oncology/American College of Pathologists guidelines.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within
10 days of treatment initiation.
Female subjects were not pregnant, breastfeeding, and had been on birth control for at
least 24 months after the last dose.
Subjects can sign informed consent to participate in the study. Appropriate organ function;
All screening period laboratory tests should be completed within 10 days prior to the start
of study therapy.
Exclusion Criteria:
Has a history of invasive malignancy ≤5 years prior to signing informed consent except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12
months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1),
anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent
directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated
antigen-4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9
(TNFRSF9)]) or has previously participated in a pembrolizumab (MK-3475) clinical study.
Is currently participating in or has participated in an interventional clinical study with
an investigational compound or device within 4 weeks of the first dose of treatment in this
current study.
Has received a live vaccine within 30 days of the first dose of study treatment.
Has an active autoimmune disease that has required systemic treatment in past 2 years
(i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing
exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive
therapy within 7 days prior to the first dose of study treatment.
Has a known history of Human Immunodeficiency Virus (HIV). Has known active Hepatitis B or
Hepatitis C. Has a history of (non-infectious) pneumonitis that required steroids or
current pneumonitis.
Has an active infection requiring systemic therapy. Has significant cardiovascular disease,
such as: history of myocardial infarction, acute coronary syndrome or coronary
angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure
(CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
Is pregnant or breastfeeding, or expecting to conceive children within the projected
duration of the study, starting with the screening visit through 12 months after the last
dose of study treatment for participants who have received cyclophosphamide, and for 6
months after the last dose of study treatment for participants who have not.
Has a known hypersensitivity to the components of the study treatment or its analogs.
Has a known history of active tuberculosis (TB, Bacillus Tuberculosis).