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NCT Number: NCT06725082

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Collagen Protein Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Peking University People's Hospital

Beijing, China, 100044

Location status: Recruiting

Location contact

Mengmeng Zhang

CONTACT

[email protected]

86-18800197038

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

Primary outcomes

  1. Short-term postoperative complications after surgery and radiotherapy.

    Time frame: 3 month

    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.

Secondary outcomes

  1. Changes in clinical pathological indicators

    Time frame: 3 month

    For patients undergoing breast tumor surgery, observe changes in immune cell infiltration (CD4, CD8, FoxP3, CD80, CD206, etc.), fibroblast activation (FAP, α-SMA, S100a4, etc.), extracellular matrix remodeling (COL3A1, COL1A1), and cancer cell activation status (ki-67, P27, etc.) in postoperative pathological tissue to assess the impact of rhCOL3 on the tumor microenvironment.

Study contacts

Contact information is provided by the study sponsor or research team.

Mengmeng Zhang

CONTACT

[email protected]

86-18800197038

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Acronym: ColBreast

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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