A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer
NCT05681728 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2023-01-12
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
Conditions
Interventions
- DRUG
-
On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion
- DRUG
-
On Day 1 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion
- DRUG
-
Epirubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection
- DRUG
-
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2024-02-01
- Completion
- 2024-06-01
Countries
- China
Study Locations
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