Survival of BCS vs Mx in Asymptomatic Screen-detected NPBC

Breast Cancer Clinical Trial

Official title:

Long-term Survival of Breast-conserving Surgery Versus Mastectomy in Asymptomatic Screen-detected Unilateral and Bilateral, Unifocal and Multifocal, Young and Elderly Non-palpable Breast Cancer Among Chinese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103032
• Other study ID #: PUMCH-BSBM
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: October 1, 2023
• Est. primary completion date: December 31, 2022
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Breast Conserving Surgery
Patients undergoing breast conserving surgery
• Mastectomy
Patients undergoing mastectomy

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinicopathological characteristics were compared between BCS and Mx patients		15 years
Primary	The prognosis was compared between BCS and Mx patients		15 years