IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)
IMBASSA
IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA)
1 other identifier
observational
2,295
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2018
CompletedFirst Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedJuly 9, 2019
April 1, 2019
11 months
April 29, 2019
July 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
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 Outcomes (3)
Overall Survival
one day
Invasive Disease Free Survival
one day
Distant Disease Free Survival
one day
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Clinical, radiological or histological confirmed metastatic disease
- Non-invasive breast cancer,
- Patients who received incomplete treatment
- Patients who did not speak French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Jean Minjoz
Besançon, Franche-Comté, 25030, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2019
First Posted
July 9, 2019
Study Start
July 28, 2017
Primary Completion
June 21, 2018
Study Completion
June 21, 2018
Last Updated
July 9, 2019
Record last verified: 2019-04