Breast CancerSA02NCT00912080
Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer
A study testing genomic signature in people with Breast Cancer, run by Institut Paoli-Calmettes at 4 sites in France.
Trial summary
Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- genomic signature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2007to May 2015
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 18 and 70
- Patient with life condition < 2 (WHO scale)
- One-sided breast adenocarcinoma with a histological evidence (all type)
- Clinical presentation which allowed a complete surgery with healthy limits
- Absence of metastasis detectable at clinical examination or radiology
- Histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (N > 1)
- The beginning of the chemotherapy within 6 weeks following the primary surgery
Who cannot join
- All metastatic affect
- Tumor classed >= T4a: cutaneous invasion, deep adherence, inflammatory breast
- All chemotherapy, hormonotherapy or radiotherapy before surgery
- Tumoral residue not removed
- Any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled
- History of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Léon BERARD
Lyon
Institut PAOLI-CALMETTES
Marseille
Centre Antoine LACASSAGNE
Nice
Chu Font-Pre
Toulon
About this study
Official title: Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.
Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100).
The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor.
Read more
Patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy.
Primary objective:
- To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies.
Secondary Objectives:
- Overall survival.
- Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery.
- Histological and seric proteomic exploratory studies.
- Conditions
- Breast Cancer
- Being tested
- genomic signature
- Keywords
- genomic signature, lymph nodes, no metastases
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genomic signatureGenetic
genomic signature analysis
| Study group | Role | What they receive |
|---|---|---|
| good signature | Experimental | Patients who have a "good signature" for the genomic analysis. They will receive the standard chemotherapy. Receives: Genetic: genomic signature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of metastasis free survival at 5 years of the patients who had a good genomic signature. The metastasis free survival is defined by the time between the histological diagnosis of the breast cancer and the apparition of the first metastasis.
Measured: 5 years
Secondary outcomes (3)
Time between collection for the genomic signature study and the beginning of the chemotherapy.
Measured: 6 weeks
Seric and histological proteomic exploratory studies with SELDI-TOF MS to: search correlation with histo-clinical or/and molecular parameter and to identify one or few proteic signature with a prognosis value.
Measured: 6 weeks
Overall survival.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startApr 2007
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 375 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
- NCT00912080
- Sponsor's protocol ID
- SA02/IPC 2006-003
- Acronym
- SA02
- Status last verified
- Mar 2013
- First submitted
- 29 May 2009
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT00912080
- Acronym / sponsor ID
- SA02 / SA02/IPC 2006-003
- Conditions
- Breast Cancer
- Keywords
- genomic signature, lymph nodes, no metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 3 Jun 2009 (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.
Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100).
The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor.
Patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy.
Primary objective:
- To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies.
Secondary Objectives:
- Overall survival.
- Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery.
- Histological and seric proteomic exploratory studies.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| good signature | Experimental | Genetic: genomic signaturePatients who have a "good signature" for the genomic analysis. They will receive the standard chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged between 18 and 70
- Patient with life condition < 2 (WHO scale)
- One-sided breast adenocarcinoma with a histological evidence (all type)
- Clinical presentation which allowed a complete surgery with healthy limits
- Absence of metastasis detectable at clinical examination or radiology
Key exclusion criteria (6 listed)
- All metastatic affect
- Tumor classed >= T4a: cutaneous invasion, deep adherence, inflammatory breast
- All chemotherapy, hormonotherapy or radiotherapy before surgery
- Tumoral residue not removed
- Any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled
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 |
|---|---|---|
| genomic signaturegenomic signature analysis | Genetic | good signature |
Primary outcome
Estimation of metastasis free survival at 5 years of the patients who had a good genomic signature. The metastasis free survival is defined by the time between the histological diagnosis of the breast cancer and the apparition of the first metastasis.
Time frame: 5 years
3 secondary outcomes
Time between collection for the genomic signature study and the beginning of the chemotherapy.
Time frame: 6 weeks
Seric and histological proteomic exploratory studies with SELDI-TOF MS to: search correlation with histo-clinical or/and molecular parameter and to identify one or few proteic signature with a prognosis value.
Time frame: 6 weeks
Overall survival.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- official site of the sponsorLink 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 genomic signature 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 7 inclusion and 6 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 20 Mar 2013. 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?
Estimation of metastasis free survival at 5 years of the patients who had a good genomic signature. The metastasis free survival is defined by the time between the histological diagnosis of the breast cancer and the apparition of the first metastasis. (time frame: 5 years). 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 20 Mar 2013.