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

Peking University

Status and phase: Enrolling; Phase 1

Conditions: Breast Cancer; Collagen Protein

Treatments: Biological: Recombinant Humanized Type III Collagen Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06725082

PKUPH2024PHD011-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

rhCOL3 Injection Group

Experimental group

Description:

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).

Treatment:

Biological: Recombinant Humanized Type III Collagen Injection

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Biological: Recombinant Humanized Type III Collagen Injection