Survival of BCS vs Mx in Asymptomatic Screen-detected NPBC

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06103032

Enrollment

1020

Registered

2023-10-26

Start date

2022-01-01

Completion date

2023-10-01

Last updated

2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

PROCEDUREBreast Conserving Surgery

Patients undergoing breast conserving surgery

PROCEDUREMastectomy

Patients undergoing mastectomy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame
The clinicopathological characteristics were compared between BCS and Mx patients	15 years
The prognosis was compared between BCS and Mx patients	15 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026