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

NCT ID: NCT04613674

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 441 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2024-03-05

Brief 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).

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm A

Group Type: EXPERIMENTAL

Camrelizumab Plus Chemotherapy

Intervention Type: DRUG

camrelizumab+chemotherapy

Arm B

Group Type: EXPERIMENTAL

placebo+chemotherapy

Intervention Type: DRUG

placebo+chemotherapy

Interventions

Camrelizumab Plus Chemotherapy

camrelizumab+chemotherapy

Intervention Type: DRUG

placebo+chemotherapy

placebo+chemotherapy

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Cancer Hospital

Shanghai, , China

Countries

China

References

Chen L, Li H, Zhang H, Yang H, Qian J, Li Z, Ren Y, Wang S, Fu P, Yang H, Liu Y, Sun J, Nie J, Lei R, Yao Y, Zhang A, Wang S, Ma X, Ouyang Z, Yang H, Wu SY, Cao SW, Wang K, Jiang A, Ouyang Q, Pang D, Wei L, Zha X, Shen Y, Qu X, Wu F, Zhu X, Wang Z, Fan L, Shao ZM. Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer: The CamRelief Randomized Clinical Trial. JAMA. 2025 Feb 25;333(8):673-681. doi: 10.1001/jama.2024.23560.

Reference Type: DERIVED

PMID: 39671272 (View on PubMed)

Other Identifiers

SHR1210-III-322

Identifier Type: -

Identifier Source: org_study_id