Using Type III Collagen to Improve Outcomes After Breast Tumor Surgery
Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery: a Multicenter, Prospective, Randomized, Open-label, Parallel-controlled Trial Protocol
This study is testing if a special type of collagen can help breast cancer patients recover better and have fewer complications after their surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, China) |
| Trial ID | NCT06725082 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of recombinant humanized Type III Collagen (rhCOL3) on patients undergoing breast tumor surgery. It aims to evaluate the incidence of perioperative complications and assess aesthetic outcomes and tumor-related pathological indicators following local rhCOL3 injection. The study is designed as a multicenter, prospective, randomized, open-label, parallel-controlled trial, focusing on the dual functions of local protection and tumor progression inhibition. By administering rhCOL3 locally, the trial seeks to enhance recovery and improve surgical results for breast cancer patients.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 80 with a clinical diagnosis of breast tumors who are scheduled for surgery.
Not a fit: Patients with a history of breast cancer, severe comorbidities, or those currently receiving systemic anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved surgical outcomes and reduced complications for breast cancer patients.
How similar studies have performed: While there are no prior clinical studies specifically on COL3 in breast tumors, the approach of using collagen for tissue protection has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Females aged 18 years or older but not exceeding 80 years; 2. Clinical and imaging diagnosis of breast tumor, planned for needle biopsy; 3. Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy; 4. No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening; 5. ECOG Performance Status (PS) - 0 or 1; 6. Subjects voluntarily join this study and sign the informed consent form. Exclusion Criteria: a.Tumor-related symptoms and treatments 1）Bilateral, multiple lesions; 2) Skin damage and ulceration on the affected side of the breast; b. History of allergy to collagen products or their excipients or severe allergic constitution; c. History of breast cancer or other malignant tumors; d. Positive serum pregnancy test or lactation; e. Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.
Where this trial is running
Beijing, China
- Peking University People's Hospital — Beijing, China, China (Recruiting)
Study contacts
- Study coordinator: Mengmeng Zhang
- Email: zhangmm428@163.com
- Phone: 86-18800197038
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.