A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

• Status: Recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Participants will be randomized in a 1:1 ratio to Arm A (camrelizumab +chemotherapy) or Arm B (placebo + chemotherapy).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• ECOG Performance Status of 0-1.

• Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).

• Tumor stage: II-III.

• Adequate hematologic and organ function.

• Must be willing to use an adequate method of contraception for the course of the study.

Exclusion Criteria:

• Has a history of breast cancer.

• Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

• Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.

• Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].

• Has a diagnosis of immunodeficiency or autoimmune diseases.

• Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.

• Severe pulmonary or cardiac disease.

• Known active hepatitis C virus, or known active hepatitis B virus.

• History of organ or bone marrow transplantation.

• Pregnant or breast-feeding women.