Survival of BCS vs Mx in Asymptomatic Screen-detected NPBC
NCT ID: NCT06103032
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1020 participants
OBSERVATIONAL
2022-01-01
2023-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
Breast Conserving Surgery
Patients undergoing breast conserving surgery
Mastectomy
Patients undergoing mastectomy
Interventions
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Breast Conserving Surgery
Patients undergoing breast conserving surgery
Mastectomy
Patients undergoing mastectomy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Qiang SUN, Dr.
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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PUMCH-BSBM
Identifier Type: -
Identifier Source: org_study_id
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