IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Age of diagnosis [one day]
The date from the date of birth to the date of pathological diagnosis (Years)
- Pathological tumor size [one day]
Pathological tumoral size after partial or complete surgery Pathological size in millimeters after complete surgery
- Pathological nodal involvement [one day]
Presence of metastasis on complete lymphadenectomy
- Clinical tumor size [one day]
Clinical measurement of the tumor in millimeters after surgery
- Clinical nodal involvement [one day]
Presence of axillary lymph nodes before surgery (no versus yes)
- Estrogen receptor expression status [one day]
Expression of estrogen receptors on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
- Progesterone receptor expression status [one day]
Expression of progesterone receptor on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
- HER2 status [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 (+++).
- Sexe [one day]
Male or Female
- Scarff Bloom and Richardson grade (SBR) [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).
- In situ component [one day]
Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery
- Pathological histotype [one day]
Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery
- Metastatic sites (if available) [one day]
Metastatic sites of primary breast cancer : Nodal (other than axillary), lung, liver, bone, cerebral and other sites.
- Medical treatment [one day]
Type of chemotherapy (adjuvant, neoadjuvant, metastatic)
Secondary Outcome Measures
- Overall Survival [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.
- Invasive Disease Free Survival [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
- Distant Disease Free Survival [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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Jean Minjoz | Besançon | Franche-Comté | France | 25030 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P/2016/291