4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA) (IMBASSA)

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

Study Description
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.


Condition or disease Intervention/treatment
Breast Cancer BRCA1 Mutation BRCA2 Mutation Genetic: BRCA mutation

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 2295 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA)
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : June 21, 2018
Arms 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.

Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Contacts and Locations

Locations
Layout table for location information
France
University Hospital Jean Minjoz
Besançon, Franche-Comté, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Tracking Information
First Submitted Date April 29, 2019
First Posted Date July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date July 28, 2017
Actual Primary Completion Date June 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2019)
  • Age of diagnosis [ Time Frame: one day ]
    The date from the date of birth to the date of pathological diagnosis (Years)
  • Pathological tumor size [ Time Frame: one day ]
    Pathological tumoral size after partial or complete surgery Pathological size in millimeters after complete surgery
  • Pathological nodal involvement [ Time Frame: one day ]
    Presence of metastasis on complete lymphadenectomy
  • Clinical tumor size [ Time Frame: one day ]
    Clinical measurement of the tumor in millimeters after surgery
  • Clinical nodal involvement [ Time Frame: one day ]
    Presence of axillary lymph nodes before surgery (no versus yes)
  • 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%.
  • 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%.
  • 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 (+++).
  • Sexe [ Time Frame: one day ]
    Male or Female
  • 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).
  • In situ component [ Time Frame: one day ]
    Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery
  • Pathological histotype [ Time Frame: one day ]
    Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery
  • 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.
  • Medical treatment [ Time Frame: one day ]
    Type of chemotherapy (adjuvant, neoadjuvant, metastatic)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 8, 2019)
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)
Official Title IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA)
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Breast Cancer
  • BRCA1 Mutation
  • BRCA2 Mutation
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.
Study Groups/Cohorts 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.
Intervention: Genetic: BRCA mutation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2019)
2295
Original Actual Enrollment Same as current
Actual Study Completion Date June 21, 2018
Actual Primary Completion Date June 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04012229
Other Study ID Numbers P/2016/291
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date April 2019

治疗医院