Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mmCOCABIO000NCT02266420
Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm
A study testing Blood samples of 10 mL in people with Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm, run by Institut Claudius Regaud at 11 sites in France.
Trial summary
This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm. All consecutive patients will be recruited by each investigator after completion of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm
- What is being tested?
- Blood samples of 10 mL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 11 sitesFrance
- Study dates
- 23 Oct 2014to 29 Oct 2024
- 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
- Woman with age ≥ 18 years.
- Patient who completed surgery for his breast cancer and for which definitive histo-pathological analysis of surgical specimen is available.
- Invasive breast carcinoma pN0 or pN(i+) with histological tumor size ≤ 10 mm (pT1a/b subgroup) or invasive breast carcinoma with histological tumor size > 10 mm and ≤ 30 mm (pT1c T2 ≤ 30 mm control group).
- Patient with HER2-negative breast carcinoma: immuno-histochemistry (IHC) score = 0, 1+ or 2+ and in situ hybridization (FISH, CISH, or SISH) negative (local laboratory testing).
- Patient with ER and PR negative invasive carcinoma (< 1% stained cells by immuno-histochemistry assay) (local laboratory testing).
- In case of multifocality, the histological size of the largest tumor must be ≤ 10 mm or ≤ 30 mm according to the inclusion subgroup. All lesions must be ER, PR and HER2-negative.
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- In case of breast conserving surgery, clear margins are required.
- Patient affiliated to a Social Health Insurance in France.
- Patient information and written informed consent form signed prior to any study specific procedures.
Who cannot join
- Patients with any previous malignancy of the breast or other site, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer totally resected.
- Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively).
- Inoperable breast invasive carcinoma.
- Synchronous bilateral breast cancer.
- Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery).
- Pregnant or breast-feeding women.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Institut de Cancerologie de L'Ouest - Site Paul Papin
Angers, 49933
Centre Francois Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
CH Emile ROUX
Le Puy-en-Velay, 43000
CHU de LIMOGES - HOPITAL DUPUYTREN
Limoges, 87042
Institut Paoli Calmettes
Marseille, 13273
Institut Regional Du Cancer Montpellier
Montpellier, 34298
Clinique La Croix Du Sud
Quint-Fonsegrives, 31130
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
Saint-Herblain, 44805
Institut Claudius Regaud
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm.
This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm.
All consecutive patients will be recruited by each investigator after completion of surgery. No modification of standard management according to each investigator center will be done. All patients will then be followed each year during 5 years in order to collect the following events: local and loco regional recurrence, metastatasis, second cancer, death or not and the cause.
Read more
At initial visit, a 10 mL blood sample will be collected (= study intervention) and immediately processed for serum storage; all serum samples will be stored at -80°C and may be used for the purpose of further scientific research.
A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be addressed at the Institut Claudius Regaud for central collection which will consist of one haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA).
Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to detect gene copy number alterations such as gains/amplifications/deletions, and to next generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation detection.
- Being tested
- Blood samples of 10 mL
- Keywords
- Triple negative breast cancer, immuno-histochemistery, genomic profiles
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples of 10 mLProcedure or surgery
Blood samples of 10 mL will be collected at initial visit; serum samples will then be stored at the end of the study (-80°C) and may be used for the purpose of further scientific research.
| Study group | Role | What they receive |
|---|---|---|
| TNBC pT1a/b with size < or = 10 mm | Other | Patients with pN0 triple negative breast tumor with size < or = 10 mm (pT1a/b) Study intervention = blood samples collected at initial visit Receives: Procedure: Blood samples of 10 mL |
| TNBC pT1c T2 with size <or = 30 mm | Other | Patients with pN0 triple negative breast tumor with size < or = 30 mm (pT1c T2) Study intervention = blood samples collected at initial visit Receives: Procedure: Blood samples of 10 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker signature for pT1a/b pN0 triple-negative breast cancers versus pN0 triple-negative breast cancers with size > or = 11 mm and < or = 30 mm.
biomarker signature will be defined from the protein expression of one or several biomarker(s).
Measured: 3 years.
Secondary outcomes (4)
Disease free survival.
Disease Free Survival is defined as the time from inclusion until any recurrence (local or regional), contro-lateral breast cancer, second primary breast cancer, distant metastasis, or death from any cause.
Measured: 7 years.
Metastasis Free Survival.
Metastasis Free Survival is defined as the time from inclusion until distant metastasis or last follow-up news (censored data). All other events are ignored for this endpoint.
Measured: 7 years.
Overall survival.
Overall survival is defined as the time from inclusion until death from any cause or last follow-up news (censured data).
Measured: 7 years.
Description and comparison of gene copy number (array-CGH) and gene mutation (targeted NGS) between pT1a/b pN0 triple-negative breast cancer versus pN0 triple-negative breast cancer with size ≥ 11 mm and ≤ 30 mm.
Measured: 7 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start23 Oct 2014
- Primary completion26 Jul 2021
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mmStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence DALENC, Md., Study chair, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266420
- Sponsor's protocol ID
- 14 SEIN 09
- Acronym
- COCABIO000
- Status last verified
- Aug 2024
- First submitted
- 13 Oct 2014
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm.
- ClinicalTrials.gov ID
- NCT02266420
- Acronym / sponsor ID
- COCABIO000 / 14 SEIN 09
- Keywords
- Triple negative breast cancer, immuno-histochemistery, genomic profiles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 17 Oct 2014 (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.
This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm.
All consecutive patients will be recruited by each investigator after completion of surgery. No modification of standard management according to each investigator center will be done. All patients will then be followed each year during 5 years in order to collect the following events: local and loco regional recurrence, metastatasis, second cancer, death or not and the cause.
At initial visit, a 10 mL blood sample will be collected (= study intervention) and immediately processed for serum storage; all serum samples will be stored at -80°C and may be used for the purpose of further scientific research.
A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be addressed at the Institut Claudius Regaud for central collection which will consist of one haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA).
Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to detect gene copy number alterations such as gains/amplifications/deletions, and to next generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation detection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNBC pT1a/b with size < or = 10 mm | Other | Procedure: Blood samples of 10 mLPatients with pN0 triple negative breast tumor with size < or = 10 mm (pT1a/b) Study intervention = blood samples collected at initial visit |
| TNBC pT1c T2 with size <or = 30 mm | Other | Procedure: Blood samples of 10 mLPatients with pN0 triple negative breast tumor with size < or = 30 mm (pT1c T2) Study intervention = blood samples collected at initial visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Woman with age ≥ 18 years.
- Patient who completed surgery for his breast cancer and for which definitive histo-pathological analysis of surgical specimen is available.
- Invasive breast carcinoma pN0 or pN(i+) with histological tumor size ≤ 10 mm (pT1a/b subgroup) or invasive breast carcinoma with histological tumor size > 10 mm and ≤ 30 mm (pT1c T2 ≤ 30 mm control group).
- Patient with HER2-negative breast carcinoma: immuno-histochemistry (IHC) score = 0, 1+ or 2+ and in situ hybridization (FISH, CISH, or SISH) negative (local laboratory testing).
- Patient with ER and PR negative invasive carcinoma (< 1% stained cells by immuno-histochemistry assay) (local laboratory testing).
Key exclusion criteria (8 listed)
- Patients with any previous malignancy of the breast or other site, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer totally resected.
- Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively).
- Inoperable breast invasive carcinoma.
- Synchronous bilateral breast cancer.
- Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery).
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 |
|---|---|---|
| Blood samples of 10 mLBlood samples of 10 mL will be collected at initial visit; serum samples will then be stored at the end of the study (-80°C) and may be used for the purpose of further scientific research. | Procedure or surgery | TNBC pT1a/b with size < or = 10 mm, TNBC pT1c T2 with size <or = 30 mm |
Primary outcome
Biomarker signature for pT1a/b pN0 triple-negative breast cancers versus pN0 triple-negative breast cancers with size > or = 11 mm and < or = 30 mm.
Time frame: 3 years.
biomarker signature will be defined from the protein expression of one or several biomarker(s).
4 secondary outcomes
Disease free survival.
Time frame: 7 years.
Metastasis Free Survival.
Time frame: 7 years.
Overall survival.
Time frame: 7 years.
Description and comparison of gene copy number (array-CGH) and gene mutation (targeted NGS) between pT1a/b pN0 triple-negative breast cancer versus pN0 triple-negative breast cancer with size ≥ 11 mm and ≤ 30 mm.
Time frame: 7 years.
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 3 Dec 2024.
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.
Florence DALENC, Md. study chair
Institut Claudius Regaud
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples of 10 mL in people with Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm, run by Institut Claudius Regaud at 11 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 9 inclusion and 8 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Biomarker signature for pT1a/b pN0 triple-negative breast cancers versus pN0 triple-negative breast cancers with size > or = 11 mm and < or = 30 mm. (time frame: 3 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 3 Dec 2024.