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

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


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).

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note