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

Breast Cancer Clinical Trial

— IMBASSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012229
• Other study ID #: P/2016/291
• Status: Completed
• Start date: July 28, 2017
• Est. completion date: June 21, 2018

Study information

• Verified date: April 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2295
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Jean Minjoz	Besançon	Franche-Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

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