Using Type III Collagen to Improve Outcomes After Breast Tumor Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University People's Hospital
  Beijing, China, China Recruiting

Study contacts

• Study coordinator: Mengmeng Zhang
• Email: zhangmm428@163.com
• Phone: 86-18800197038

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.