IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)

Study Overview
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Brief Summary
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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.

Official Title
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IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA)

Conditions
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Breast Cancer, BRCA1 Mutation, BRCA2 Mutation

Intervention / Treatment
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* Genetic: BRCA mutation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years old, 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: Clinical, radiological or histological confirmed metastatic disease Non-invasive breast cancer, Patients who received incomplete treatment Patients who did not speak French

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated by chemotherapy for an early breast cancer<br>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. | Genetic: BRCA mutation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age of diagnosis | The date from the date of birth to the date of pathological diagnosis (Years) | one day | 
| Pathological tumor size | Pathological tumoral size after partial or complete surgery Pathological size in millimeters after complete surgery | one day | 
| Pathological nodal involvement | Presence of metastasis on complete lymphadenectomy | one day | 
| Clinical tumor size | Clinical measurement of the tumor in millimeters after surgery | one day | 
| Clinical nodal involvement | Presence of axillary lymph nodes before surgery (no versus yes) | one day | 
| Estrogen receptor expression status | Expression of estrogen receptors on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%. | one day | 
| Progesterone receptor expression status | Expression of progesterone receptor on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%. | one day | 
| HER2 status | Expression of HER2 on tumor after surgery (expression assessed by immuno-histo-chemistry, if HER2 is ++, fluorescence in situ hybridization. HER2 status is ranged to not overexpressed (0 and +), equivocal (++) and overexpressed (+++). | one day | 
| Sexe | Male or Female | one day | 
| Scarff Bloom and Richardson grade (SBR) | This grade is the addition of score of tubule formation (>75% 1 point 10%-75% 2 point <10% 3 points), nuclear pleomorphism (small, regular uniform cells 1 point moderate increase in size and variability 2 points, marked Variation 3 points) and mitotic counts (dependent on microscope field area 1-3 points) assessed by pathology analysis on tumor after surgery. The SBR grade is ranging from I (total of 3 to 5), II (6 and 7) and III (8 and 9). | one day | 
| In situ component | Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery | one day | 
| Pathological histotype | Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery | one day | 
| Metastatic sites (if available) | Metastatic sites of primary breast cancer : Nodal (other than axillary), lung, liver, bone, cerebral and other sites. | one day | 
| Medical treatment | Type of chemotherapy (adjuvant, neoadjuvant, metastatic) | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The time from the date of first treatment or of first consultation, whichever comes first, to the date of death from any cause. | one day | 
| Invasive Disease Free Survival | The time from the date of the first treatment or th first consultation to the date of local or ipsilateral or controlateral invasive breast cancer, or other invasive cancer or distant recurrence or death from breast cancer or any cause | one day | 
| Distant Disease Free Survival | The time from the date of the first treatment or the first consultation to the date of distant recurrence or death from breast cancer or any cause | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, BRCA1, BRCA2, Chemotherapy