What is this study trying to find out about breast cancer reconstruction?

This study is evaluating the cosmetic effects, quality of life, and safety of breast reconstruction using 3D-printed biodegradable implants compared to traditional breast-conserving surgery and silicone prosthesis reconstruction. The research aims to understand if these new implants offer advantages for patients not suitable for breast-conserving surgery. The trial is sponsored by Xijing Hospital and involves multiple centers.

Who may be eligible for this breast cancer clinical trial?

Women aged 18 to 70 years with newly diagnosed primary breast cancer confirmed by histopathology may be eligible. Participants must be willing to undergo one of the surgical options and have a good performance status score of 0 or 1. Patients with certain advanced or metastatic cancers or other serious health conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the study surgery or procedures and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel-related costs.

Actively Recruiting

Phase 2

Age: 18Years - 70Years

FEMALE

ID06993714

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

Led by Xijing Hospital · Updated on 2025-06-06

120

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the cosmetic outcomes and quality of life for breast cancer patients undergoing breast reconstruction using 3D-printed biodegradable material breast implants. This study compares these results with traditional breast-conserving surgery and traditional silicone prosthesis breast reconstruction. It also explores the safety and potential medical issues related to using 3D-printed biodegradable implants for breast reconstruction in patients not suitable for breast-conserving surgery. Participants are divided into three groups one group receives breast reconstruction using 3D-printed biodegradable implants, the second undergoes traditional breast-conserving surgery, and the third has traditional silicone prosthesis breast reconstruction. The trial includes preoperative assessments, imaging with MRI, surgical planning with 3D printing of implants for the experimental group, and surgery according to each groups procedures. Postoperative care includes wound management, systemic therapies such as chemotherapy or endocrine therapy, and radiotherapy based on clinical guidelines. During the study, participants undergo regular follow-up with breast ultrasounds weekly for the first month and monthly thereafter, MRI scans at 3, 6, 12, and 24 months, and patient-reported outcome assessments using the BREAST-Q V2.0 scale to evaluate breast aesthetics, satisfaction, and quality of life. Telephone follow-ups occur monthly, with in-person visits every three months. The primary outcome measured is cosmetic effects and quality of life one year after surgery, alongside safety and long-term survival outcomes up to ten years.

CONDITIONS

Brief Title

3D-printed Biodegradable Breast Implants for Breast Restoration

Who Can Participate

Age: 18Years - 70Years

FEMALE

Eligibility Criteria

You may qualify if you...

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 of 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 will not qualify if you...

Age over 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 or 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.

Research Team

Ju liang J L Zhang

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