3D-printed Biodegradable Breast Implants for Breast Restoration

NCT06993714 | Recruiting Phase 2

• 1 other identifier: KY20252204-C-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is: Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction? Participants will: Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.

Conditions

Breast Cancer; Breast Reconstruction

Keywords

3D printing; Immediate breast reconstruction; biodegradable scaffold

Outcome Measures

Primary Outcomes (1)

• Postoperative cosmetic effects and quality of life

  Patient satisfaction in the reconstruction module of the BREAST-Q scale is used for scoring, including: satisfaction with the breast, satisfaction with the surgical outcome, and satisfaction with the treatment. Among them, the breast satisfaction score is the main endpoint of this study. After the BREAST-Q questionnaire is completed, its score is calculated and called Q-SCORE. The specific assessment requires the aid of the Q-SCORE scoring software. The surgical satisfaction score, treatment satisfaction score, and health-related quality of life (QOL) score in the Breast-Q scale include: physical, psychosocial, and sexual health. For all dimensions, the higher the score reported by patients, the higher their satisfaction and the better their quality of life.

  One year after the operation

Secondary Outcomes (4)

• Recurrence-free survival (RFS)

  Three months, half a year, one year after the operation, and then once a year thereafter until ten years

• Disease-free survival (DFS)

  Three months, half a year, one year after the operation, and then once a year thereafter until ten years

• Overall survival (OS)

  Three months, half a year, one year after the operation, and then once a year thereafter until ten years

• Surgical technique safety (incidence of complications)

  Immediately after the operation, and at 3 days, 7 days, 10 days, 14 days, 1 month, 3 months, 6 months, 12 months and 24 months after the operation

Study Arms (3)

Breast restoration surgery based on 3D printed degradable biological implants

EXPERIMENTAL

The patient will undergo breast reduction surgery based on 3D-printed degradable biological implants

Procedure: Breast restoration surgery based on 3D printed degradable biological implants

Traditional breast-conserving surgery

ACTIVE COMPARATOR

The patient will undergo traditional breast-conserving surgery

Procedure: Traditional breast-conserving surgery

Traditional silicone prosthesis breast reconstruction

ACTIVE COMPARATOR

The patient will undergo traditional silicone prosthesis breast reconstruction

Procedure: Traditional silicone prosthesis breast reconstruction

Interventions

Breast restoration surgery based on 3D printed degradable biological implants PROCEDURE

In the experimental group, the surgeon makes an incision on the skin and creates an electrosurgical free flap with a thickness of approximately 3mm. Based on the tumor size simulated by the computer and combined with real-time exploration during the operation, the tumor is resected. The incision margin is more than 1cm away from the tumor boundary. Eight to ten points are selected at equal intervals around the resected specimen. Samples are taken and sent for frozen tissue pathological section examination to ensure a negative incision margin (those with a positive incision margin are excluded from the clinical trial). Corresponding surgical treatment is provided. Axillary lymph node dissection or sentinel lymph node biopsy is routinely performed. The wound is soaked and rinsed, hemostasis is thoroughly achieved, the designed 3D printed filler is implanted, and sutured and fixed. After placing the drainage, the skin is sutured layer by layer. The corresponding operation time is recorde.

Breast restoration surgery based on 3D printed degradable biological implants

Traditional breast-conserving surgery PROCEDURE

In the control group undergoing traditional breast - saving surgery, tumor segment resection is performed according to the clinical routine. The resection margin is more than 1cm away from the tumor boundary. Eight to ten points are selected at equal intervals around the circumferential specimens after resection. Samples are taken and sent for frozen tissue pathological section examination to ensure a negative resection margin. The volume of the resected part during the intraoperative section is replaced by autologous tissue. Axillary lymph node dissection or sentinel lymph node biopsy is routinely performed. The corresponding operation time is recorded.

Traditional breast-conserving surgery

Traditional silicone prosthesis breast reconstruction PROCEDURE

In the control group of traditional prosthesis reconstruction, subcutaneous gland resection with nipple and areola preservation combined with prosthesis for concurrent breast reconstruction is carried out according to the clinical routine. The incision method is selected by the surgeon. During the operation, the tissue behind the nipple is sent for frozen tissue pathological section examination to ensure a negative incision margin (those with a positive incision margin are considered out of the clinical trial and given corresponding surgical treatment), and the surgeon decides whether to use the patch in combination. The corresponding operation time is recorded.

Traditional silicone prosthesis breast reconstruction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.
• Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material breast implants.
• Having indications for subcutaneous glandectomy that preserves the nipples and areolas.
• ECOG performance status score: 0-1.
• If receiving neoadjuvant chemotherapy, the interval between chemotherapy completion and surgery is less than 8 weeks.
• Good compliance with the planned treatment, ability to understand the study procedures, and willingness to sign the written informed consent form.

You may not qualify if:

• Age \> 70 years.
• Newly diagnosed stage IV metastatic breast cancer.
• Multicentric, extensive, or diffuse lesions; or inflammatory breast cancer.
• Tumor invasion of the papillary areola complex.
• Inability to accept/tolerate radiotherapy.
• Breast cancer during pregnancy.
• History of other malignant tumors within the past five years (except cured cervical carcinoma in situ and non-melanoma skin cancer).
• Abnormal functions of vital organs (heart, lungs, liver, kidneys), poorly controlled diabetes, or other conditions that preclude surgery tolerance.
• Patients deemed unsuitable for participation by the researchers.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (1)

• Mu X, Zhang J, Jiang Y. 3D Printing in Breast Reconstruction: From Bench to Bed. Front Surg. 2021 May 20;8:641370. doi: 10.3389/fsurg.2021.641370. eCollection 2021.

  PMID: 34095200 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ju liang J L Zhang

CONTACT

029-84775271; vascularzhang@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental group: Breast restoration surgery based on 3D printed degradable biological implants Control Group 1: Traditional breast-conserving surgery Control Group 2: Traditional silicone prosthesis breast reconstruction

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: May 29, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

CN (1)