Status:

RECRUITING

Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer

Lead Sponsor:

Zhenzhen Liu

Conditions:

Breast Cancer

Triple Negative Breast Cancer

Eligibility:

FEMALE

18-70 years

Phase:

PHASE2

Brief Summary

Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not be...

Detailed Description

This study mainly compared the efficacy and safety of 6\*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6\*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer. Patients wh...

Eligibility Criteria

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.

Key Trial Info

Start Date :

December 20 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2029

Estimated Enrollment :

369 Patients enrolled

Trial Details

Trial ID

NCT05475678

Start Date

December 20 2022

End Date

December 31 2029

Last Update

January 23 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Henan cancer hospital

Zhengzhou, Henan, China