Combining Camrelizumab with TCb for treating triple-negative breast cancer

A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer

This study is testing if combining a new drug called camrelizumab with a chemotherapy treatment can help people with triple-negative breast cancer do better after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 369 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Camrelizumab, carrelizumab
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT05475678 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18-70 with pathologically confirmed triple-negative breast cancer and measurable lesions.

Not a fit: Patients with evidence of metastatic breast cancer or those who have previously received chemotherapy, endocrine therapy, or targeted therapy for this disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and safer treatment option for patients with triple-negative breast cancer.

How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in combination with chemotherapy for various cancers, suggesting potential success for this approach in TNBC.

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.

Where this trial is running

Zhengzhou, Henan

• Henan cancer hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Zhenzhen Liu — Study Principal Investigator
• Study coordinator: Zhenzhen Liu

Conditions Breast Cancer; Triple Negative Breast Cancer; Camrelizumab; Neoadjuvant chemotherapy; Pathological complete response rate; Disease-free survival