Comparing two methods of breast reconstruction after mastectomy
Official title: The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy
Run by Beijing Friendship Hospital · NCT05833659 · Data updated 2026-11-12
This study is testing which breast reconstruction method, either above or below the muscle, works better for women after having a mastectomy for early-stage breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 88 (estimated) |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | March 2025 |
| Study ends | March 2027 |
| Registry record updated | April 27, 2023 |
| Trial ID | NCT05833659 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients aged 18 to 70 with early-stage invasive breast cancer who require total mastectomy and are willing to undergo breast reconstruction.
✕Probably not a fit
Patients with serious medical conditions or those who do not meet the eligibility criteria for breast reconstruction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the outcomes of pre-pectoral versus subpectoral breast reconstruction techniques following single-port insufflation endoscopic nipple-sparing mastectomy in women with early-stage invasive breast cancer. It is an ambispective cohort study that includes both retrospective and prospective patient data, focusing on breast satisfaction as the primary outcome. The study aims to enroll 80 patients, with a 1:1 ratio in each reconstruction group, and will analyze data collected from medical records and direct patient recruitment over a span of several years.
Why it matters
Potential benefit: If successful, this study could enhance patient satisfaction with breast reconstruction outcomes after mastectomy.
How similar studies have gone: Previous studies have explored various breast reconstruction techniques, but this specific comparison of pre-pectoral and subpectoral methods using endoscopic techniques is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy. 2. Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy. 3. Patients having willingness for breast reconstruction. 4. Age between 18 to 70 years. 5. Maximum diameter of the cancer lesion ≤ 3 cm. 6. Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall. 7. The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2. Exclusion Criteria: 1. patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months. 2. Having history of malignant tumor (s) within 5 years. 3. Patients under immunosuppressive therapy for organ transplantation. 4. Having continuous systemic steroid hormone therapy. 5. Pregnant or lactating women.
Where it's running
-
Beijing Friendship Hospital, Capital medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: guoxuan gao, MD — Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
- Study coordinator: guoxuan gao, MD
- Email: aliceggx@163.com
- Phone: +861063138712
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.