NCT04226222

Brief Summary

"Triple Negative" breast cancers are a heterogeneous group characterized by the absence of hormone receptors to estrogen, progesterone and the absence of expression or amplification of the HER-2 gene. This type of cancer is associated with an adverse clinical profile with a high risk of early metastatic relapse. Accurate identification of prognostic factors, as well as predictors of therapeutic response, and the contribution of targeted therapies are avenues for improving the management and survival of patients with these cancers. Such an approach requires optimal biological characterization, allowing us to understand the complexity of this group of tumors, and requires multidisciplinary collaboration in clinical trials involving anatomopathology, oncology and morpho-functional imaging. The investigator's goal is to characterize by innovative methods (anatomo-pathological in particular Of Immunohistochemistry, and morpho-functional imaging (TEP-TDM FDG) semi-quantitative and texture) in a population of Triple Negative Breast Cancer scans better knowledge of this entity that can lead to the development of relevant therapeutic strategies and especially more adapted in the context of precision and personalized medicine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
Last Updated

February 21, 2023

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

January 9, 2020

Last Update Submit

February 20, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.

    The 2-year event-free survival rate based on the texture parameters of the PET-TDM FDG. Event free survival is the duration between the date of diagnosis and the date of the first event (relapse, death) or the date of the last news without event.

    2 years

Secondary Outcomes (4)

  • assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immunohistochemistry parameters for 2-year event-free survival .

    2 years

  • To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry.

    2 years

  • assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry defined as relevant to 2-year event-free survival

    2 years

  • Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups

    2 years

Study Arms (1)

Triple negative Breast Cancer

Triple Negative Breast Cancer operatable from the outset

Diagnostic Test: TEP-TDM FDG

Interventions

TEP-TDM FDGDIAGNOSTIC_TEST

Semi-quantitative PET-TDM FDG Data and Texture Analysis

Triple negative Breast Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with triple negative breast cancer operatable from the outset will be

You may qualify if:

  • Patient with biopsy-proven triple-negative breast cancer, newly diagnosed, naïve from any treatment.
  • Age - 18.
  • Performance Status (PS) : 0 or 1.
  • No metastasis on the extension balance.
  • Treatment provided immediately by lumpectomy or mastectomy, and accepted by the patient.

You may not qualify if:

  • Severe illness or comorbidity at risk.
  • A history of cancer within 5 years, with the exception of skin carcinomas (other than melanoma) or in-situ cervical carcinomas.
  • Patient candidate for neo-adjuvant therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut de Cancérologie de l'Ouest

Angers, 49055, France

Location

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Caroline ROUSSEAU, MD, PhD

    caroline.rousseau@ico.unicancer.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

November 5, 2019

Primary Completion

October 22, 2022

Study Completion

October 22, 2024

Last Updated

February 21, 2023

Record last verified: 2022-08

Locations

FR(2)