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

Triple Negative Breast Cancer Clinical Trial

Official title:

A Multicentre, Randomized, Double-blind, Parallel-controlled Phase Ⅲ Study to Evaluate Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Patients With Early or Locally Advanced Triple Negative Breast Cancer (TNBC).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613674
• Other study ID #: SHR1210-III-322
• Status: Completed
• Phase: Phase 3
• Start date: December 9, 2020
• Est. completion date: March 5, 2024

Study information

• Verified date: March 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: March 5, 2024
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Camrelizumab Plus Chemotherapy
camrelizumab+chemotherapy
• placebo+chemotherapy
placebo+chemotherapy

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Event-free Survival (EFS) as assessed by Investigator.	EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.	At least 2 years
Secondary	Disease-free Survival (DFS) as assessed by Investigator	DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.	At least 2 years
Secondary	Distant Disease-free Survival (DDFS) as assessed by Investigator	DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.	At least 2 years
Secondary	Objective response rate (ORR) in accordance with RECIST v1.1	Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.	Up to approximately 24 weeks
Secondary	Percentage of Participants with Adverse Events (AEs)		Up to approximately 67 weeks