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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2024
  • participants needed
    581
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 21 March 2022
HER2
triple negative breast cancer
erbb2

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).

Details
Condition Triple Negative Breast Cancer
Treatment Camrelizumab Plus Chemotherapy, placebo+chemotherapy
Clinical Study IdentifierNCT04613674
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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