IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)
NCT ID: NCT04012229
Last Updated: 2019-07-09
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
2295 participants
OBSERVATIONAL
2017-07-28
2018-06-21
Brief Summary
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This study is a multi-center retrospective cohort of patients treated in region Franche-Comté for an early BC by neoadjuvant and/or adjuvant chemotherapy.
The primary aim was to describe clinical and pathological characteristics considering BRCA mutated (BRCAm) patients versus BRCA wild type (BRCAwt) patients or untested patients. The second objective was to assess the prognostic impact of germinal BRCAm in this high-risk population.
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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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Patients treated by chemotherapy for an early breast cancer
Patients (Women or Men) older than 18 years old, histologically confirmed invasive early breast cancer, treated by neo-adjuvant and/or adjuvant chemotherapy with the first cure of chemotherapy received between January 1st, 2003 and December 31th, 2013 were included.
BRCA mutation
The genetic testing was performed according interregional consensus (Manchester score \> or = 16) on blood sample using classical chain-termination (Sanger sequencing) and multiplex ligation-dependant probe amplification to search large rearrangements.
Interventions
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BRCA mutation
The genetic testing was performed according interregional consensus (Manchester score \> or = 16) on blood sample using classical chain-termination (Sanger sequencing) and multiplex ligation-dependant probe amplification to search large rearrangements.
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed invasive early breast cancer
* Neo-adjuvant and/or adjuvant chemotherapy with the first cure of chemotherapy received between January 1st, 2003 and December 31th, 2013
Exclusion Criteria
* Non-invasive breast cancer,
* Patients who received incomplete treatment
* Patients who did not speak French
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Locations
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University Hospital Jean Minjoz
Besançon, Franche-Comté, France
Countries
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Other Identifiers
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P/2016/291
Identifier Type: -
Identifier Source: org_study_id
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