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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)

Primary Purpose

Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples of 10 mL
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm focused on measuring Triple negative breast cancer, immuno-histochemistery, genomic profiles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut de Cancerologie de L'Ouest - Site Paul Papin
  • Centre Francois Baclesse
  • Centre Jean Perrin
  • CH Emile ROUX
  • CHU de LIMOGES - HOPITAL DUPUYTREN
  • Institut Paoli Calmettes
  • Institut Regional Du Cancer Montpellier
  • Clinique La Croix Du Sud
  • Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
  • Institut Claudius Regaud
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

TNBC pT1a/b with size < or = 10 mm

TNBC pT1c T2 with size <or = 30 mm

Arm Description

Patients with pN0 triple negative breast tumor with size < or = 10 mm (pT1a/b) Study intervention = blood samples collected at initial visit

Patients with pN0 triple negative breast tumor with size < or = 30 mm (pT1c T2) Study intervention = blood samples collected at initial visit

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Overall survival.
Overall survival is defined as the time from inclusion until death from any cause or last follow-up news (censured data).
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.

Full Information

First Posted
October 13, 2014
Last Updated
August 2, 2023
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT02266420
Brief Title
Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm
Acronym
COCABIO000
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 23, 2014 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm
Keywords
Triple negative breast cancer, immuno-histochemistery, genomic profiles

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNBC pT1a/b with size < or = 10 mm
Arm Type
Other
Arm Description
Patients with pN0 triple negative breast tumor with size < or = 10 mm (pT1a/b) Study intervention = blood samples collected at initial visit
Arm Title
TNBC pT1c T2 with size <or = 30 mm
Arm Type
Other
Arm Description
Patients with pN0 triple negative breast tumor with size < or = 30 mm (pT1c T2) Study intervention = blood samples collected at initial visit
Intervention Type
Procedure
Intervention Name(s)
Blood samples of 10 mL
Intervention Description
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 Measure Information:
Title
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.
Description
biomarker signature will be defined from the protein expression of one or several biomarker(s).
Time Frame
3 years.
Secondary Outcome Measure Information:
Title
Disease free survival.
Description
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.
Time Frame
7 years.
Title
Metastasis Free Survival.
Description
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.
Time Frame
7 years.
Title
Overall survival.
Description
Overall survival is defined as the time from inclusion until death from any cause or last follow-up news (censured data).
Time Frame
7 years.
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence DALENC, Md.
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Study Chair
Facility Information:
Facility Name
Institut de Cancerologie de L'Ouest - Site Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
CH Emile ROUX
City
Le Puy-en-Velay
ZIP/Postal Code
43000
Country
France
Facility Name
CHU de LIMOGES - HOPITAL DUPUYTREN
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Institut Regional Du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Clinique La Croix Du Sud
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France
Facility Name
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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