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New treatment option for Breast Cancer
Official title 3D-printed Biodegradable Breast Implants for Breast Restoration
ClinicalTrials.gov ID: NCT06993714
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join 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...
- 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.
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.