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RECRUITINGNCT05833659

Comparison Between Prepectoral and Subpectoral Breast Reconstruction

There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthe...

Lead sponsor: Beijing Friendship Hospital•1 locations•View source on ClinicalTrials.gov

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Contacts

guoxuan gao, MD

CONTACT

+861063138712 aliceggx@163.com

Sponsors

Lead Sponsor

Beijing Friendship Hospital

Collaborators

Beijing Health Promotion Association

Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 27, 2023Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment88

Start dateMar 2022

Last updatedApr 27, 2023

Condition

Stage II Breast Cancer Stage I Breast Cancer

Locations shown

Beijing Friendship Hospital, Capital medical University

Beijing, Beijing Municipality

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2023Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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