A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)

Launched by FUDAN UNIVERSITY · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial, called BCTOP-T-N01, is looking at a new treatment approach for women with triple-negative breast cancer (TNBC), a type of breast cancer that does not respond to certain hormones or HER2 proteins. The study is testing whether adding a medication called famitinib to the standard chemotherapy and another drug called camrelizumab can improve treatment outcomes before surgery. Participants will be randomly assigned to receive either the chemotherapy with or without famitinib, and those who respond well will have surgery to remove the tumor. After surgery, the women will be followed for at least two years to see how well the treatment works and to monitor their health.

To be eligible for this trial, women must be between 18 and 75 years old, have early-stage or locally advanced TNBC, and show good overall health. They should not have had previous treatment for breast cancer or certain other cancers within the last five years, and they must not be pregnant or breastfeeding. Throughout the study, participants will receive regular check-ups to assess their response to the treatment and monitor any side effects. This trial is currently recruiting, and participants are encouraged to discuss their options with their healthcare provider.

Gender

FEMALE

Eligibility 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;