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Trial Title:
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
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Cyclophosphamide
Pembrolizumab
Epirubicin
Conditions: Keywords:
breast cancer
neoadjuvant therapy
immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of
17 cycles; intravenous (IV) infusion
Arm group label:
Pembrolizumab combined with chemotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
On Day 1 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion
Arm group label:
Pembrolizumab combined with chemotherapy
Intervention type:
Drug
Intervention name:
Epirubicin
Description:
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection
Arm group label:
Pembrolizumab combined with chemotherapy
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion
Arm group label:
Pembrolizumab combined with chemotherapy
Summary:
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
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Ma
Phone:
010-87788120
Email:
drmafei@126.com
Start date:
February 1, 2022
Completion date:
June 1, 2024
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05681728
