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Search / Trial NCT05833659

Comparison Between Prepectoral and Subpectoral Breast Reconstruction

Launched by BEIJING FRIENDSHIP HOSPITAL · Apr 16, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Breast Cancer Endoscopic Nipple Sparing Mastectomy Breast Reconstruction Breast Satisfaction Breast Q Score

ClinConnect Summary

This clinical trial is comparing two different methods of breast reconstruction after a mastectomy for women with early-stage breast cancer (stage I or stage II). The researchers want to find out which method—placing the implant above the chest muscle (pre-pectoral) or below it (subpectoral)—provides better satisfaction with the appearance of the breast after surgery. This study is taking place at Beijing Friendship Hospital and involves both reviewing past patient records and enrolling new participants.

To be eligible for this trial, women must be between the ages of 18 and 70 and have breast cancer that is not suitable for breast-conserving surgery. They should also be willing to undergo breast reconstruction. Participants will be assessed for their satisfaction with their breasts after surgery using a special questionnaire called the BREAST-Q score. The study is currently recruiting participants, and those who join can expect close monitoring and support throughout the process. It's an important opportunity to help improve breast reconstruction outcomes for future patients.

Gender

FEMALE

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.

About Beijing Friendship Hospital

Beijing Friendship Hospital, affiliated with Capital Medical University, is a leading comprehensive medical institution located in Beijing, China. Renowned for its advanced clinical services and cutting-edge research, the hospital plays a pivotal role in promoting healthcare innovation and improving patient outcomes. As a prominent clinical trial sponsor, Beijing Friendship Hospital is committed to conducting high-quality, ethical research that adheres to international standards. The hospital's multidisciplinary teams leverage their expertise across various medical fields to facilitate the development of new therapies and interventions, ultimately contributing to the advancement of medical science and public health.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

guoxuan gao, MD

Principal Investigator

Department of General Surgery, Beijing Friendship Hospital, Capital Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported