Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC
NCT06817525 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2025-12-05
Summary
We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.
Conditions
- Triple-negative Breast Cancer
Interventions
- DRUG
-
6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1)
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage. Group A: Albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles;
- DRUG
-
6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage. Group B: Albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles;
Sponsors & Collaborators
-
Henan Cancer Hospital
lead OTHER_GOV
Principal Investigators
-
Zhenzhen Liu · Henan Cancer Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-06
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- China
Study Locations
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