3D-printed Biodegradable Breast Implants for Breast Restoration

Recruiting now · Phase 2

Conditions studied: Breast Cancer, Breast Reconstruction

In brief

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.

Key facts

Study ID

NCT06993714

Run by

Xijing Hospital

People needed

120

Starts

2025-05-01

Expected to finish

2028-12-31

Last updated by the study team

2025-06-06

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Xijing hospital — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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