Survival of BCS vs Mx in Asymptomatic Screen-detected NPBC

October 22, 2023 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1020

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer
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
Procedure: Breast Conserving Surgery
Patients undergoing breast conserving surgery
Procedure: Mastectomy
Patients undergoing mastectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Qiang SUN, Dr., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-BSBM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No sharing according to the privacy of patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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