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

NCT04368468 | Completed

• 1 other identifier: 19HLSEIN02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Triple Negative Breast Cancer

Keywords

post neo adjuvant therapy; immune micro environment; biomerker chacterization

Outcome Measures

Primary Outcomes (4)

• Identify Change of immune ME by TILS quantification of triple-negative breast cancer induced by neoadjuvant chemotherapy for all patients

  TILS ans substype quantification

  12 months

• Identify Change of immune ME by PDL1 expression of triple-negative breast cancer induced by neoadjuvant chemotherapy for all patients

  expression of PDL1,

  12 months

• Identify Change of immune ME by TIM3 expression of triple-negative breast cancer induced by neoadjuvant chemotherapy for all patients

  expression of TIM3

  12 months

• Identify Change of immune ME by LAG3 expression of triple-negative breast cancer induced by neoadjuvant chemotherapy for all patients

  LAG3 expression

  12 months

Secondary Outcomes (8)

• Compare change ofTILs quantification of triple-negative breast cancer induced by neoadjuvant chemotherapy for pCR patients and those not pCR and for subtype basal-like or not basal-like

  12 months

• Compare change of PDL1 expression of triple-negative breast cancer induced by neoadjuvant chemotherapy for pCR patients and those not pCR and for subtype basal-like or not basal-like

  12 months

• Compare change of TIM3 expression of triple-negative breast cancer induced by neoadjuvant chemotherapy for pCR patients and those not pCR and for subtype basal-like or not basal-like

  12 months

• Compare change of LAG3 expression of triple-negative breast cancer induced by neoadjuvant chemotherapy for pCR patients and those not pCR and for subtype basal-like or not basal-like

  12 months

• determination of predictive factors of TILs quantification for response to neoadjuvant chemotherapy and disease free survival

  12 months

Interventions

biomarker evolution OTHER

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

Also known as: triple negative breast cancer biomarker evolution

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 samples

You may qualify if:

• Samples from triple negative BC patients, patients treated by neoadjuvant chemotherapy ( FEC or EC than taxanes) Patients consent to use their samples.

You may not qualify if:

• Samples not available before or after neoadjuvant chemotherapy

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut claudius regaud

Toulouse, 31059, France

Location

Related Publications (25)

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Biospecimen

Retention: SAMPLES WITH DNA

microbiopsy of the breast primary tumor preserved in FFPE and of the operative part preserved in FFPE.

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 29, 2020
• Study Start: June 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: January 31, 2021
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)