Survival of BCS vs Mx in Asymptomatic Screen-detected NPBC

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Breast Conserving Surgery; Procedure: Mastectomy

• Registration Number: NCT06103032
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

We performed this study on a consecutive cohort of women with asymptomatic screen-detected NPBC. The clinicopathological characteristics, 10-year relapse-free survival (RFS) and overall survival (OS) were compared between BCS and Mx patients among different subgroups.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-10
• Study Completion: 2023-10-01
• Study First Submitted: 2023-10-22
• Study First Submitted QC: 2023-10-22
• Last Update Submitted: 2023-10-22
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1020

Inclusion Criteria

Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.

Age of at least 18 and at most 90 years. Performance status (Karnofsky-Index) >80%. Chemotherapy is necessary before or after surgery. No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.

Life expectancy of at least 2 years, disregarding the diagnosis of cancer. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.

Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria

Known hypersensitivity reaction to the investigational compounds or incorporated substances.

Local recurrence and/or metastasis of breast cancer. No need of chemotherapy. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.

Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.

Concurrent treatment with other experimental drugs or any other anti-cancer therapy.

Males.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer	Breast Conserving Surgery	a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer treated in Dept. Breast Surgery, PUMC Hospital from January 2003 to December 2017
a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer	Mastectomy	a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer treated in Dept. Breast Surgery, PUMC Hospital from January 2003 to December 2017

Primary Outcome Measures

Name	Time	Method
The prognosis was compared between BCS and Mx patients	15 years
The clinicopathological characteristics were compared between BCS and Mx patients	15 years

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China