MedTrace Logo

Modifications of Immune Microenvironment Induced by Neoadjuvant Chemotherapy in Triple-negative BC

NCT04368468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-12-23

No results posted yet for this study

Summary

The prescription of neoadjuvant chemotherapy becomes a standard in women with HER2-positive or triple-negative breast cancer and allows a complete histological response (pCR) which represents a prognostic factor for survival. . The problem for patients who are not pCR is that they are currently receiving non-personalized adjuvant systemic treatment.

The identification of biomarkers present in the residual disease would be a criterion to guide the choice of post-neoadjuvant adjuvant systemic treatment, in order to personalize it.

At the present time, there is no published study describing extensively the immune micro-environment (ME) in breast cancer, whether before or after chemotherapy, nor its modification induced by chemotherapy.

The team therefore propose to study in a retrospective and monocentric series, the modifications of the immune ME induced by a "standard" neo-adjuvant chemotherapy in patients with triple-negative CS, whether they are in complete histological response or not (n = twice 50).

The main objective of this project is to describe the changes in the immune ME of triple-negative breast cancers induced by neoadjuvant chemotherapy for all patients (in pCR or not):

* Quantification of TILs and subtypes of TILs (CD4 and CD8)
* Expression of the three immune checkpoints that are PDL1, TIM3 and LAG3
* Describe the organization of the immune system (immunostaining on the same slide of the PDL1, TIM3 and LAG3 immune checkpoints)

Conditions

Interventions

OTHER

biomarker evolution

analysis of a list of biomarkers on triple negative breast tumors samples before and after neoadjuvant therapy

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2020-12-15
Completion
2021-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368468 on ClinicalTrials.gov