Phase III Study of Camrelizumab Plus Chemotherapy With or Without Famitinib as Pre-Surgery Treatment in Women With Triple Negative Breast Cancer

What this Trial Is About

Researchers are evaluating the use of camrelizumab combined with chemotherapy, with or without famitinib, as neoadjuvant pre-surgery treatment in participants with early or locally advanced triple-negative breast cancer TNBC. This Phase III, open-label, randomized, controlled study divides participants based on tumor stage and CD8 expression. The goal is to assess the pathological complete response rate and other survival outcomes after treatment and surgery. Participants are randomly assigned to one of two groups one receives camrelizumab plus chemotherapy albumin-paclitaxel and carboplatin combined with famitinib, and the other receives camrelizumab plus chemotherapy without famitinib. After completing neoadjuvant therapy, participants suitable for surgery will undergo surgical treatment followed by pathological evaluation. Those in the experimental group continue receiving camrelizumab and famitinib for up to one year from the start of therapy, while those in the control group continue camrelizumab alone for the same duration. During the study, participants are monitored for disease progression, side effects, and overall safety. Imaging assessments according to RECIST 1.1 are performed before surgery to evaluate treatment response. After surgery, participants will be followed for at least two years to track event-free survival, disease-free survival, distant metastasis-free survival, and safety. Safety data collection continues from the time of consent until 28 days after study completion.

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)