A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer
NCT ID: NCT05681728
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
26 participants
INTERVENTIONAL
2022-02-01
2024-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pembrolizumab combined with chemotherapy
Pembrolizumab
On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion
Paclitaxel
On Day 1 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion
Epirubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection
Cyclophosphamide
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion
Interventions
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Pembrolizumab
On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion
Paclitaxel
On Day 1 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion
Epirubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection
Cyclophosphamide
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion
Eligibility Criteria
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Inclusion Criteria
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 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).
18 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Ma Fei，MD
Deputy Director of the Department of Medical Oncology
Locations
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC3340
Identifier Type: -
Identifier Source: org_study_id
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