Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
FEMALE
NCT04925856

Immunomonitoring of Breast Cancer Patients During Systemic Treatment

Led by Centre Georges Francois Leclerc · Updated on 2023-10-17

150

Participants Needed

2

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.

CONDITIONS

Official Title

Immunomonitoring of Breast Cancer Patients During Systemic Treatment

Who Can Participate

Age: 18Years - 85Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Woman aged between 18 and 85
  • Histologically proven infiltrating breast cancer
  • Breast cancer is triple negative or hormone receptor positive/HER2 negative as defined
  • Receiving treatment in one of these cohorts: metastatic with Paclitaxel, metastatic with Epirubicin-cyclophosphamide, metastatic with Eribulin, or first-line metastatic with Palbociclib, Abemaciclib, or Ribociclib combined with hormone therapy
  • Signed informed consent for the study
  • Fit and able to follow the protocol including visits, specimen collection, and follow-up
  • Affiliated with the social security system
Not Eligible

You will not qualify if you...

  • Unable to understand, read, or sign informed consent
  • Presence of cerebral or meningeal metastasis
  • Use of immunosuppressive drugs within 14 days before inclusion, except certain corticosteroids
  • Participation in another research that may alter systemic treatment within the cohort
  • Pregnant or breastfeeding
  • Positive for HIV, HBV, or HCV serology
  • Life expectancy less than 3 months
  • Refusal to participate
  • Under adult protection systems such as tutorship or curatorship
  • Unable to undergo medical monitoring due to geographical, social, or psychological reasons

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

CHRU Jean Minjoz

Besançon, France, 25000

Not Yet Recruiting

2

Centre Georges Francois Leclerc

Dijon, France, 21079

Actively Recruiting

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Research Team

S

Sylvain LADOIRE, PU-PH

CONTACT

E

Emilie REDERSTORFF

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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