Study of Recombinant Humanized Type III Collagen Injection During Breast Tumor Surgery to Improve Healing and Long-Term Outcomes

What this Trial Is About

Breast tumors, especially breast cancer, are becoming more common in China with an increasing number of younger patients. Research suggests that Type III Collagen COL3 plays an important role in protecting tissues and organs within the tumor environment and may slow tumor progression by remodeling this environment. However, no clinical studies have yet explored COL3 in breast tumors. This trial aims to study the effects of locally injecting recombinant humanized Type III Collagen rhCOL3 during breast tumor surgery to assess its potential benefits and safety. Participants will be randomly assigned to one of two groups one group will receive injections of rhCOL3 around the tumor before surgery and again around the surgical area skin after confirming safe surgical margins during surgery. The other group will receive saline injections following the same procedure as a control. The rhCOL3 will be given at specific points around the tumor and along the skin incision during surgery. This study is a multicenter, prospective, randomized, open-label, parallel-controlled trial. During the study, participants will be monitored for short-term complications after surgery and radiotherapy over a three-month period. Researchers will also observe changes in clinical pathological indicators related to the tumor. Assessments will include clinical and imaging evaluations, with follow-up visits to track outcomes. The goal is to establish whether local rhCOL3 injection can provide protection and support treatment in breast tumor surgery over both immediate and long-term periods.

Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery