University Hospital Jean Minjoz
Besançon, Franche-Comté, 25030, France
NCT Number: NCT04012229
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Besançon, Franche-Comté, 25030, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: one day
The date from the date of birth to the date of pathological diagnosis (Years)
Time frame: one day
Pathological tumoral size after partial or complete surgery
Pathological size in millimeters after complete surgery
Time frame: one day
Presence of metastasis on complete lymphadenectomy
Time frame: one day
Clinical measurement of the tumor in millimeters after surgery
Time frame: one day
Presence of axillary lymph nodes before surgery (no versus yes)
Time frame: one day
Expression of estrogen receptors on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
Time frame: one day
Expression of progesterone receptor on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
Time frame: one day
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
Male or Female
Time frame: one day
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
Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery
Time frame: one day
Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery
Time frame: one day
Metastatic sites of primary breast cancer : Nodal (other than axillary), lung, liver, bone, cerebral and other sites.
Time frame: one day
Type of chemotherapy (adjuvant, neoadjuvant, metastatic)
Time frame: one day
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
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
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
Centre Hospitalier Universitaire de Besancon
Other
IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA)
Acronym: IMBASSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04108117
BRCA1 Mutation, BRCA2 Mutation
Seoul, South Korea
View Trial DetailsNCT04890327
BRCA1 Mutation, BRCA2 Mutation
New York, United States
View Trial DetailsNCT03066856
BRCA1 Mutation, BRCA2 Mutation
Milan, Italy
View Trial DetailsNCT03428399
BRCA1 Mutation, BRCA2 Mutation
Boston, Massachusetts, United States
View Trial Details