Combining Camrelizumab and Chemotherapy for Triple-Negative Breast Cancer Treatment
A Randomized, Open Label, Multicenter Phase III Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
This study is testing if adding a new drug called camrelizumab, with or without famitinib, to standard chemotherapy can improve treatment for people with triple-negative breast cancer before surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | bevacizumab, famitinib, Sunitinib, chemotherapy, radiation, carrilizumab |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT05999149 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with early or locally advanced, histologically confirmed triple-negative breast cancer who have an ECOG performance status of 0-1.
Not a fit: Patients with a history of breast cancer or those who have received prior chemotherapy or targeted therapies within the last 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could improve surgical outcomes and overall survival rates for patients with triple-negative breast cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating triple-negative breast cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.