An observational study in Breast Cancer, BRCA1 Mutation and BRCA2 Mutation, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by Centre Hospitalier Universitaire de Besancon · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 2,295 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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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.
Exclusion Criteria:
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
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.
Age of diagnosis
The date from the date of birth to the date of pathological diagnosis (Years)
Time frame: one day
Pathological tumor size
Pathological tumoral size after partial or complete surgery Pathological size in millimeters after complete surgery
Time frame: one day
Pathological nodal involvement
Presence of metastasis on complete lymphadenectomy
Time frame: one day
Clinical tumor size
Clinical measurement of the tumor in millimeters after surgery
Time frame: one day
Clinical nodal involvement
Presence of axillary lymph nodes before surgery (no versus yes)
Time frame: one day
Estrogen receptor expression status
Expression of estrogen receptors on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
Time frame: one day
Progesterone receptor expression status
Expression of progesterone receptor on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
Time frame: 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 (+++).
Time frame: one day
Sexe
Male or Female
Time frame: 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).
Time frame: one day
In situ component
Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery
Time frame: one day
Pathological histotype
Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery
Time frame: one day
Metastatic sites (if available)
Metastatic sites of primary breast cancer : Nodal (other than axillary), lung, liver, bone, cerebral and other sites.
Time frame: one day
Medical treatment
Type of chemotherapy (adjuvant, neoadjuvant, metastatic)
Time frame: one day
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.
Time frame: 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
Time frame: 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
Time frame: one day
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Besancon