3D-printed biodegradable breast implants for breast reconstruction

A Prospective, Multicenter, Controlled Clinical Study of 3D-printed Biodegradable Breast Implants for Breast Restoration

This study is testing if 3D-printed biodegradable breast implants can improve the look and safety of breast reconstruction for women with newly diagnosed breast cancer compared to traditional methods.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Xijing Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06993714 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the cosmetic effects and safety of breast reconstruction using 3D-printed biodegradable material implants in women with newly diagnosed primary breast cancer. Participants will be divided into three groups: one receiving the experimental biodegradable implants, and two control groups undergoing traditional breast-conserving surgery or silicone prosthesis reconstruction. The study aims to compare the quality of life and cosmetic outcomes between these methods. It also assesses the feasibility of using these innovative implants for patients who are not suitable for traditional surgical options.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 70 with newly diagnosed primary breast cancer who are eligible for breast-conserving surgery or reconstruction.

Not a fit: Patients over 70 years old, those with stage IV metastatic breast cancer, or those with extensive lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more personalized and effective option for breast reconstruction, improving cosmetic outcomes and quality of life for patients.

How similar studies have performed: While the use of 3D printing in medical applications is growing, this specific approach to biodegradable breast implants is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Xi'an, Shaanxi

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

Study contacts

• Study coordinator: Ju liang J L Zhang

Conditions Breast Cancer; Breast Reconstruction; 3D printing; Immediate breast reconstruction; biodegradable scaffold