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NOT YET RECRUITING
NCT07107217
PHASE2

Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer

Sponsor: Blokhin's Russian Cancer Research Center

View on ClinicalTrials.gov

Summary

To explore the application of Camrelizumab with chemotherapy as neoadjuvant treatment of early-stage TNBC. Phase II clinical study of Camrelizumab in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Camrelizumab and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-08

Completion Date

2027-12

Last Updated

2025-08-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Camrelizumab

200 mg by intravenous (iv.) infusion every 2 weeks (Q2W) for 10 times

DRUG

Doxorubicin +cyclophosphamide+ filgrastimum

Doxorubicin 60mg/m² + cyclophosphamide 600 mg/m² on Day 1 of Cycles 1-4 (Q2W) of the first neoadjuvant phase of the study, IV infusion. filgrastim (G-CSF) subcutaneously on days 2-6 of Cycles 1-4

DRUG

carboplatin + paclitaxel (CP)

carboplatin AUC 2 and paclitacel 80 mg/m² will be given on day 1 every 12 weeks of the second neoadjuvant phase of the study, IV infusion.