Relationship between the presence of the BRCA mutation (BReast Cancer) and outcomes is unclear in high-risk early breast cancers (BC).
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.
Condition or disease | Intervention/treatment |
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Breast Cancer BRCA1 Mutation BRCA2 Mutation | Genetic: BRCA mutation |
Study Type : | Observational |
Actual Enrollment : | 2295 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA) |
Actual Study Start Date : | July 28, 2017 |
Actual Primary Completion Date : | June 21, 2018 |
Actual Study Completion Date : | June 21, 2018 |
Group/Cohort | Intervention/treatment |
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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.
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Genetic: 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.
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Pathological tumoral size after partial or complete surgery
Pathological size in millimeters after complete surgery
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients treated in region Franche-Comté, France, for an early breast cancer, by neoadjuvant and/or adjuvant chemoterapy.
Eight center were included : University hospital of Besançon, Polyclinique de Franche-Comté (Besançon), Clinique Saint-Vincent (Besançon), Hospitals of Vesoul, Lons-le-Saunier, Pontarlier, Dole and Montbéliard.
Inclusion Criteria:
Exclusion Criteria:
France | |
University Hospital Jean Minjoz | |
Besançon, Franche-Comté, France, 25030 |
Tracking Information | |||||
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First Submitted Date | April 29, 2019 | ||||
First Posted Date | July 9, 2019 | ||||
Last Update Posted Date | July 9, 2019 | ||||
Actual Study Start Date | July 28, 2017 | ||||
Actual Primary Completion Date | June 21, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA) | ||||
Official Title | IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA) | ||||
Brief Summary |
Relationship between the presence of the BRCA mutation (BReast Cancer) and outcomes is unclear in high-risk early breast cancers (BC). 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 | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population |
Patients treated in region Franche-Comté, France, for an early breast cancer, by neoadjuvant and/or adjuvant chemoterapy. Eight center were included : University hospital of Besançon, Polyclinique de Franche-Comté (Besançon), Clinique Saint-Vincent (Besançon), Hospitals of Vesoul, Lons-le-Saunier, Pontarlier, Dole and Montbéliard. |
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Condition |
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Intervention | Genetic: 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.
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Study Groups/Cohorts | 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.
Intervention: Genetic: BRCA mutation
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
2295 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | June 21, 2018 | ||||
Actual Primary Completion Date | June 21, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04012229 | ||||
Other Study ID Numbers | P/2016/291 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Centre Hospitalier Universitaire de Besancon | ||||
Study Sponsor | Centre Hospitalier Universitaire de Besancon | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Centre Hospitalier Universitaire de Besancon | ||||
Verification Date | April 2019 |