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

Completed

• Conditions: BRCA1 Mutation; BRCA2 Mutation; Breast Cancer
• Interventions: Genetic: BRCA mutation

• Registration Number: NCT04012229
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-28
• Primary Completion: 2018-06-21
• Study Completion: 2018-06-21
• Status Verified: 2019-04
• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-07-08
• Last Update Submitted: 2019-07-08
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2295

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated by chemotherapy for an early breast cancer	BRCA mutation	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.

Primary Outcome Measures

Name	Time	Method
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).
Pathological nodal involvement	one day	Presence of metastasis on complete lymphadenectomy
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 (+++).
Metastatic sites (if available)	one day	Metastatic sites of primary breast cancer : Nodal (other than axillary), lung, liver, bone, cerebral and other sites.
Age of diagnosis	one day	The date from the date of birth to the date of pathological diagnosis (Years)
Clinical nodal involvement	one day	Presence of axillary lymph nodes before surgery (no versus yes)
Pathological histotype	one day	Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery
Medical treatment	one day	Type of chemotherapy (adjuvant, neoadjuvant, metastatic)
Pathological tumor size	one day	Pathological tumoral size after partial or complete surgery; Pathological size in millimeters after complete surgery
Estrogen receptor expression status	one day	Expression of estrogen receptors on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
In situ component	one day	Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery
Clinical tumor size	one day	Clinical measurement of the tumor in millimeters after surgery
Progesterone receptor expression status	one day	Expression of progesterone receptor on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
Sexe	one day	Male or Female

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Jean Minjoz; 🇫🇷 Besançon, Franche-Comté, France