Clinical trial NCT04613674: A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 441
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: 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.
timeFrame: Up to approximately 24 weeks
Secondary outcomes:
measure: Event-free Survival (EFS) as assessed by Investigator.
timeFrame: At least 2 years
measure: Disease-free Survival (DFS) as assessed by Investigator
timeFrame: At least 2 years
measure: Distant Disease-free Survival (DDFS) as assessed by Investigator
timeFrame: At least 2 years
measure: Objective response rate (ORR) in accordance with RECIST v1.1
timeFrame: Up to approximately 24 weeks
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 67 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
References: