Neoadjuvant Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer
NCT05088057 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2021-10-21
Summary
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab plus chemotherapy as neoadjuvant therapy and Camrelizumab as adjuvant therapy in participants who have triple negative breast cancer (TNBC).
Conditions
- Triple Negative Breast Cancer (TNBC)
Interventions
- DRUG
-
Camrelizumab
200mg on Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles (Q3W), intravenous (IV) infusion.
- DRUG
-
Doxorubicin
60mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.
- DRUG
-
600 mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.
- DRUG
-
75mg/m² on Day 1 of Cycles 1-4 (Q3W) or Cycles 5-8 (Q3W) of the neoadjuvant phase of the study, IV infusion;
Sponsors & Collaborators
-
Aiping Shi
lead OTHER
Principal Investigators
-
Aiping Shi, PhD · The First Hospital of Jilin University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-20
- Primary Completion
- 2024-08-19
- Completion
- 2024-11-01
Countries
- China
Study Locations
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