Breast CancerNCT01434420
Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
A study testing BRCA1 BRCA2 PTEN PALB2 mutation in people with Breast Cancer, run by Institut Paoli-Calmettes at 4 sites in France.
Trial summary
Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BRCA1 BRCA2 PTEN PALB2 mutation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2011to Mar 2020
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women > 18
- non metastatic breast cancer
- triple negative
- 5 years follow-up
- signed informed consent
Who cannot join
- other cancer (except in situ)
- metastases at diagnosis
- impossibility of follow-up
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre jean Perrin
Clermont-Ferrand, 63011
Hopital La Timone
Marseille, 13005
Institut Paoli-Calmettes
Marseille, 13009
Centre Antoine Lacassagne
Nice, 06189
About this study
Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.
Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.
Read more
The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.
The 5 years relapse-free survival will also be estimated.
- Conditions
- Breast Cancer
- Being tested
- BRCA1 BRCA2 PTEN PALB2 mutation
- Keywords
- triple negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRCA1 BRCA2 PTEN PALB2 mutationGenetic
detection of BRCA1 BRCA2 PTEN PALB2 mutation
| Study group | Role | What they receive |
|---|---|---|
| Triple negative breast cancer | Experimental | Triple negative breast cancer Receives: Genetic: BRCA1 BRCA2 PTEN PALB2 mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations
- Determine the incidence of the BRCA1/2, PALB2, PTEN, PALB2 mutations in patients having at diagnosis a non metastatic triple negative breast cancer
Measured: up to 1 month
Secondary outcomes (2)
molecular profiles
- Determine by tissue micro- array and transcriptome the molecular profiles and their correlation with the presence of a mutation
Measured: up to 1 month
years relapse-free survival
- Determine the 5 years relapse-free survival in presence or not of a mutation, and according to the molecular profile of expression.
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2014
- Study completionMar 2020 (estimated)
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 Institut Paoli-CalmettesThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc EXTRA, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434420
- Sponsor's protocol ID
- SA03/IPC 2010-003
- Status last verified
- Dec 2014
- First submitted
- 13 Sep 2011
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
- ClinicalTrials.gov ID
- NCT01434420
- Acronym / sponsor ID
- SA03/IPC 2010-003
- Conditions
- Breast Cancer
- Keywords
- triple negative breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2020 (estimated)
- First posted
- 14 Sep 2011 (estimated)
- 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.
Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.
Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.
The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.
The 5 years relapse-free survival will also be estimated.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple negative breast cancer | Experimental | Genetic: BRCA1 BRCA2 PTEN PALB2 mutationTriple negative breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- women > 18
- non metastatic breast cancer
- triple negative
- 5 years follow-up
- signed informed consent
Key exclusion criteria (3 listed)
- other cancer (except in situ)
- metastases at diagnosis
- impossibility of follow-up
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 |
|---|---|---|
| BRCA1 BRCA2 PTEN PALB2 mutationdetection of BRCA1 BRCA2 PTEN PALB2 mutation | Genetic | Triple negative breast cancer |
Primary outcome
incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations
Time frame: up to 1 month
1) Determine the incidence of the BRCA1/2, PALB2, PTEN, PALB2 mutations in patients having at diagnosis a non metastatic triple negative breast cancer
2 secondary outcomes
molecular profiles
Time frame: up to 1 month
years relapse-free survival
Time frame: at 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- sponsor web siteLink provided by the sponsor.
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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.
Jean-Marc EXTRA, MD principal investigator
Institut Paoli-Calmettes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRCA1 BRCA2 PTEN PALB2 mutation in people with Breast Cancer, run by Institut Paoli-Calmettes at 4 sites 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
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?
incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations (time frame: up to 1 month). 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 31 Dec 2014.