Comparing two methods of breast reconstruction after mastectomy

The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy

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
• Enrollment: 88 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05833659 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

Why it matters

Potential benefit: If successful, this study could enhance patient satisfaction with breast reconstruction outcomes after mastectomy.

How similar studies have performed: Previous studies have explored various breast reconstruction techniques, but this specific comparison of pre-pectoral and subpectoral methods using endoscopic techniques is relatively novel.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions Stage II Breast Cancer; Stage I Breast Cancer; breast cancer; endoscopic nipple-sparing mastectomy; breast reconstruction; breast satisfaction; BREAST-Q score