3D-printed biodegradable breast implants for breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xijing hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Ju liang J L Zhang
• Email: vascularzhang@163.com
• Phone: 029-84775271

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.