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Completed

NCT Number: NCT04012229

IMpact of Breast cAncer Gene 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Jean Minjoz

Besançon, Franche-Comté, 25030, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BRCA mutation

Genetic

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.

Primary outcomes

  1. Age of diagnosis

    Time frame: one day

    The date from the date of birth to the date of pathological diagnosis (Years)

  2. Pathological tumor size

    Time frame: one day

    Pathological tumoral size after partial or complete surgery

    Pathological size in millimeters after complete surgery

  3. Pathological nodal involvement

    Time frame: one day

    Presence of metastasis on complete lymphadenectomy

  4. Clinical tumor size

    Time frame: one day

    Clinical measurement of the tumor in millimeters after surgery

  5. Clinical nodal involvement

    Time frame: one day

    Presence of axillary lymph nodes before surgery (no versus yes)

  6. Estrogen receptor expression status

    Time frame: one day

    Expression of estrogen receptors on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.

  7. Progesterone receptor expression status

    Time frame: one day

    Expression of progesterone receptor on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.

  8. HER2 status

    Time frame: 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 (+++).

  9. Sexe

    Time frame: one day

    Male or Female

  10. Scarff Bloom and Richardson grade (SBR)

    Time frame: 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).

  11. In situ component

    Time frame: one day

    Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery

  12. Pathological histotype

    Time frame: one day

    Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery

  13. Metastatic sites (if available)

    Time frame: one day

    Metastatic sites of primary breast cancer : Nodal (other than axillary), lung, liver, bone, cerebral and other sites.

  14. Medical treatment

    Time frame: one day

    Type of chemotherapy (adjuvant, neoadjuvant, metastatic)

Secondary outcomes

  1. Overall Survival

    Time frame: 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.

  2. Invasive Disease Free Survival

    Time frame: 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

  3. Distant Disease Free Survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: IMBASSA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2019
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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