3D-printed Biodegradable Breast Implants for Breast Restoration

Launched by XIJING HOSPITAL · May 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of breast implant made from biodegradable material that is 3D-printed, aimed at helping women with breast cancer who need breast reconstruction. The goal is to understand how effective these implants are compared to traditional breast-conserving surgery and silicone implants, particularly in terms of appearance, quality of life, and safety. The researchers want to find out if these new implants can provide a better option for women who are not suitable for breast-conserving surgery and to identify any potential medical issues that might arise from their use.

To participate in this trial, women aged 18 to 70 with newly diagnosed primary breast cancer may be eligible, especially if they are willing to have either the new 3D-printed implant or one of the traditional procedures. Participants will be divided into groups: one will receive the new biodegradable implants, while others will have traditional surgeries. Throughout the study, participants can expect to be monitored for how well the implants work and how they feel about their recovery and overall quality of life. It's important for potential participants to discuss their individual health situations with their doctors to determine if they qualify for the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.