Survival of BCS vs Mx in Asymptomatic Screen-detected NPBC

NCT06103032 | Completed

• 1 other identifier: PUMCH-BSBM
• Study Type: observational
• Target: 1,020
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• The clinicopathological characteristics were compared between BCS and Mx patients

  15 years

• The prognosis was compared between BCS and Mx patients

  15 years

Study Arms (1)

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; Procedure: Mastectomy

Interventions

Breast Conserving Surgery PROCEDURE

Patients undergoing breast conserving surgery

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

Mastectomy PROCEDURE

Patients undergoing mastectomy

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Mastectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Qiang SUN, Dr.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: October 1, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)