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Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm (COCABIO000)

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ClinicalTrials.gov Identifier: NCT02266420
Recruitment Status : Active, not recruiting
First Posted : October 17, 2014
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm Procedure: Blood samples of 10 mL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : October 23, 2014
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
TNBC pT1a/b with size < or = 10 mm
Patients with pN0 triple negative breast tumor with size < or = 10 mm (pT1a/b) Study intervention = blood samples collected at initial visit
Procedure: Blood samples of 10 mL
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.

TNBC pT1c T2 with size <or = 30 mm
Patients with pN0 triple negative breast tumor with size < or = 30 mm (pT1c T2) Study intervention = blood samples collected at initial visit
Procedure: Blood samples of 10 mL
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Disease free survival. [ Time Frame: 7 years. ]
    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.

  2. Metastasis Free Survival. [ Time Frame: 7 years. ]
    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.

  3. Overall survival. [ Time Frame: 7 years. ]
    Overall survival is defined as the time from inclusion until death from any cause or last follow-up news (censured data).

  4. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Woman with age ≥ 18 years.
  2. Patient who completed surgery for his breast cancer and for which definitive histo-pathological analysis of surgical specimen is available.
  3. 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).
  4. 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).
  5. Patient with ER and PR negative invasive carcinoma (< 1% stained cells by immuno-histochemistry assay) (local laboratory testing).
  6. 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.
  7. In case of breast conserving surgery, clear margins are required.
  8. Patient affiliated to a Social Health Insurance in France.
  9. Patient information and written informed consent form signed prior to any study specific procedures.

Exclusion Criteria:

  1. 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.
  2. Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively).
  3. Inoperable breast invasive carcinoma.
  4. Synchronous bilateral breast cancer.
  5. Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery).
  6. Pregnant or breast-feeding women.
  7. 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.
  8. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266420


Locations
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France
Institut de Cancerologie de L'Ouest - Site Paul Papin
Angers, France, 49933
Centre Francois Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
CH Emile ROUX
Le Puy-en-Velay, France, 43000
CHU de LIMOGES - HOPITAL DUPUYTREN
Limoges, France, 87042
Institut Paoli Calmettes
Marseille, France, 13273
Institut Regional Du Cancer Montpellier
Montpellier, France, 34298
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
Saint-Herblain, France, 44805
Institut Claudius Regaud
Toulouse, France, 31059
Clinique St Jean Du Languedoc
Toulouse, France, 31077
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
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Study Chair: Florence DALENC, Md. Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT02266420     History of Changes
Other Study ID Numbers: 14 SEIN 09
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Keywords provided by Institut Claudius Regaud:
Triple negative breast cancer
immuno-histochemistery
genomic profiles
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases