Breast CancerIMBASSANCT04012229
IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)
An observational study of Breast Cancer and BRCA1 Mutation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- What is being tested?
- BRCA mutation
- How many people
- 2,295 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2017to 21 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Clinical, radiological or histological confirmed metastatic disease
- Non-invasive breast cancer,
- Patients who received incomplete treatment
- Patients who did not speak French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Being tested
- BRCA mutation
- Keywords
- Breast cancer, BRCA1, BRCA2, Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRCA mutationGenetic
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: BRCA mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of diagnosis
The date from the date of birth to the date of pathological diagnosis (Years)
Measured: one day
Pathological tumor size
Pathological tumoral size after partial or complete surgery
Pathological size in millimeters after complete surgery
Measured: one day
Pathological nodal involvement
Presence of metastasis on complete lymphadenectomy
Measured: one day
Clinical tumor size
Clinical measurement of the tumor in millimeters after surgery
Measured: one day
Clinical nodal involvement
Presence of axillary lymph nodes before surgery (no versus yes)
Measured: one day
Estrogen receptor expression status
Expression of estrogen receptors on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
Measured: one day
Progesterone receptor expression status
Expression of progesterone receptor on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
Measured: 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 (+++).
Measured: one day
Sexe
Male or Female
Measured: 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).
Measured: one day
In situ component
Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery
Measured: one day
Pathological histotype
Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery
Measured: one day
Metastatic sites (if available)
Metastatic sites of primary breast cancer : Nodal (other than axillary), lung, liver, bone, cerebral and other sites.
Measured: one day
Medical treatment
Type of chemotherapy (adjuvant, neoadjuvant, metastatic)
Measured: one day
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start28 Jul 2017
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012229
- Sponsor's protocol ID
- P/2016/291
- Acronym
- IMBASSA
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA)
- ClinicalTrials.gov ID
- NCT04012229
- Acronym / sponsor ID
- IMBASSA / P/2016/291
- Conditions
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Keywords
- Breast cancer, BRCA1, BRCA2, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,295 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated by chemotherapy for an early breast cancer | – | Genetic: BRCA mutationPatients (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Clinical, radiological or histological confirmed metastatic disease
- Non-invasive breast cancer,
- Patients who received incomplete treatment
- Patients who did not speak French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRCA mutationThe 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. | Genetic | Patients treated by chemotherapy for an early breast cancer |
Primary outcome
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)
3 secondary outcomes
Overall Survival
Time frame: one day
Invasive Disease Free Survival
Time frame: one day
Distant Disease Free Survival
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and BRCA1 Mutation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age of diagnosis (time frame: one day). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.