Combining Camrelizumab with TCb for treating triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of combining camrelizumab, a PD-1 inhibitor, with a chemotherapy regimen known as TCb in patients with triple-negative breast cancer (TNBC). Participants will be randomly assigned to receive either the combination treatment or the TCb regimen alone over six cycles. The study aims to evaluate outcomes such as pathological complete response rate and disease-free survival after surgery. By exploring this combination, the trial seeks to improve treatment options for patients with this aggressive form of breast cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18-70 years old
2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
3. Pathologically proven triple negative breast cancer:

   Triple-negative breast cancer is defined as:
   * Negative for ER and PR (IHC nuclear staining \<10%)
   * Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
6. Cardiac ultrasound EF value ≧55%；
7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
8. ECOG score≤1 point;
9. Sign informed consent；

Exclusion Criteria:

1. The patient has evidence of metastatic breast cancer；
2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
3. The patient has a second primary malignancy other than adequately treated skin cancer;
4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
6. The patient has severe lung or heart disease;
7. The patient has active hepatitis B and C;
8. The patient has a history of organ transplantation or bone marrow transplantation;
9. pregnant or breastfeeding women;
10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.

Where it's running

• Henan cancer hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Zhenzhen Liu — Study Principal Investigator
• Study coordinator: Zhenzhen Liu
• Email: liuzhenzhen73@126.com
• Phone: 13603862755

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using mistletoe extract with pembrolizumab for treating triple negative breast cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.