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)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; BRCA1 Mutation; BRCA2 Mutation
• Intervention / Treatment: Genetic: BRCA mutation

• Study Type: Observational
• Enrollment (Actual): 2295

Contacts and Locations

Study Locations

• France
  • Franche-Comté
    • Besançon, Franche-Comté, France, 25030
      • University Hospital Jean Minjoz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	one day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2017
• Primary Completion (Actual): June 21, 2018
• Study Completion (Actual): June 21, 2018

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer; Chemotherapy; BRCA2; BRCA1
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: P/2016/291

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No