Combining Camrelizumab and Chemotherapy for Triple-Negative Breast Cancer Treatment

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 Phase III clinical trial investigates the effectiveness of camrelizumab combined with chemotherapy, with or without famitinib, as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). Participants are randomly assigned to receive either the combination treatment or the standard chemotherapy regimen. The study evaluates the efficacy of these treatments through imaging and pathological assessments after neoadjuvant therapy and before surgery. The trial aims to determine if the addition of famitinib enhances treatment outcomes for patients with early or locally advanced TNBC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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. Patients who have previously received VEGFR-like small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, Sunitinib, regorafenib, etc.) (except bevacizumab); Urine routine indicated urinary protein ≥2+ and confirmed urinary protein quantity \> 1g at 24h;

Where it's running

• Breast cancer institute of Fudan University Cancer Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Fudan University Shanghai Cancer Center Shanghai, China, 200032
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: chen li, MD
• Email: chen_li@fudan.edu.cn
• Phone: +86-021-64175590

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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.