NCT05088057

Neoadjuvant Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer

A Phase Ⅱ Study to Evaluate the Efficacy and Safety of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy With Triple Negative Breast Cancer (TNBC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Aiping Shi · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (camrelizumab + chemotherapy) for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 2-4 weeks after the last cycle of the neoadjuvant treatment. After definitive surgery, each participant will receive adjuvant study treatment (camrelizumab) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that camrelizumab is superior to chemotherapy, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR), Event-free Survival (EFS) and Objective Overall Response Rate (ORR) in participants with TNBC.

Conditions

• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
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	Cyclophosphamide	600 mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.
DRUG	Docetaxel	75mg/m² on Day 1 of Cycles 1-4 (Q3W) or Cycles 5-8 (Q3W) of the neoadjuvant phase of the study, IV infusion;

Timeline

• Start date: 2021-09-20
• Primary completion: 2024-08-19
• Completion: 2024-11-01
• First posted: 2021-10-21
• Last updated: 2021-10-21

Locations

1 site across 1 country: China