Status:
RECRUITING
3D-printed Biodegradable Breast Implants for Breast Restoration
Lead Sponsor:
Xijing Hospital
Conditions:
Breast Cancer
Breast Reconstruction
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
This is a prospective, multicenter, controlled clinical study divided into three groups. The experimental group receives breast reconstruction using 3D-printed biodegradable material breast implants, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06993714
Start Date
May 1 2025
End Date
December 31 2028
Last Update
June 6 2025
Active Locations (1)
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1
Xijing hospital
Xi'an, Shaanxi, China, 710032