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

NCT06725082 | Recruiting Phase 1

• 1 other identifier: PKUPH2024PHD011-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Breast tumors, particularly breast cancer, are increasingly prevalent in China, with a noticeable trend towards younger ages. Preliminary research indicates that Type III Collagen (COL3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through microenvironmental remodeling. However, there are no clinical studies related to COL3 in breast tumors. This project aims to initiate a multicenter, prospective, randomized, open-label, parallel-controlled trial by locally administering recombinant humanized Type III Collagen (rhCOL3) to patients undergoing breast tumor surgery. The study will observe the incidence of perioperative complications after rhCOL3 injection, as well as changes in aesthetic outcomes and tumor-related pathological indicators following breast tumor surgery with local rhCOL3 injection. The goal is to establish a targeted rhCOL3 local injection therapy with dual functions of local protection and synergistic treatment, providing a new strategy for the treatment of breast tumors.

Conditions

Breast Cancer; Collagen Protein

Outcome Measures

Primary Outcomes (1)

• Short-term postoperative complications after surgery and radiotherapy.

  The purpose of this study is to assess the incidence rate of short-term complications within 3 months after patients complete surgery and radiotherapy. The main complications are defined as surgery or radiotherapy-related complications occurring during postoperative follow-up, including delayed wound healing, partial skin necrosis, infection, and hematoma and seroma; common adverse reactions related to breast radiotherapy include acute radiation dermatitis, breast edema, pain, etc., and late-stage breast fibrosis, edema, atrophy, telangiectasia, etc.

  3 month

Secondary Outcomes (1)

• Changes in clinical pathological indicators

  3 month

Study Arms (2)

rhCOL3 Injection Group

EXPERIMENTAL

RhCOL3 will be prepared as a 4mg/ml and injected around the tumor. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, a second injection of 2ml will be administered around the surgical area skin (at points spaced along the skin incision).

Biological: Recombinant Humanized Type III Collagen Injection

Control Group

PLACEBO COMPARATOR

4ml of saline will be injected around the tumor before surgery. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, 2ml of saline will be injected around the breast surgical area skin.

Biological: Recombinant Humanized Type III Collagen Injection

Interventions

Recombinant Humanized Type III Collagen Injection BIOLOGICAL

rhCOL3/saline will be injected around the tumor (at four points: outer upper, inner upper, outer lower, and inner lower) before surgery, with 500ul per site. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, a second injection of 2ml will be administered around the surgical area skin (at points spaced along the skin incision), followed by routine tissue flap revision and suture.

Control Group; rhCOL3 Injection Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 18 years or older but not exceeding 80 years;
• Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;
• Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;
• No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;
• ECOG Performance Status (PS) - 0 or 1;
• Subjects voluntarily join this study and sign the informed consent form.

You may not qualify if:

• a.Tumor-related symptoms and treatments
• ）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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China, 100044, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mengmeng Zhang

CONTACT

86-18800197038; zhangmm428@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor，director of breast center

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)