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

NCT04613674 | Completed Phase 3

• 1 other identifier: SHR1210-III-322
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery.

  Up to approximately 24 weeks

Secondary Outcomes (5)

• Event-free Survival (EFS) as assessed by Investigator.

  At least 2 years

• Disease-free Survival (DFS) as assessed by Investigator

  At least 2 years

• Distant Disease-free Survival (DDFS) as assessed by Investigator

  At least 2 years

• Objective response rate (ORR) in accordance with RECIST v1.1

  Up to approximately 24 weeks

• Percentage of Participants with Adverse Events (AEs)

  Up to approximately 67 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Camrelizumab Plus Chemotherapy

Arm B

EXPERIMENTAL

Drug: placebo+chemotherapy

Interventions

Camrelizumab Plus Chemotherapy DRUG

camrelizumab+chemotherapy

Arm A

placebo+chemotherapy DRUG

placebo+chemotherapy

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 39671272 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 3, 2020
• Study Start: December 9, 2020
• Primary Completion: September 14, 2023
• Study Completion: March 5, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)