Research and Analysis of the Mechanisms Involved in the Emergence of Breast Cancer Stem Cells (RepriM)

NCT02570100 | Terminated

• 2 other identifiers: RepriM-14072014-AO1806-41
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

From a cellular perspective, breast cancers appear to develop hierarchically from a small contingent of cancer stem cells (CSCs). The presence of CSCs in tumor tissue is associated with an increased risk of recurrence and metastasis, as well as a worse prognosis. Thus, these CSCs exhibit resistance to conventional anti-tumor treatments such as radiotherapy and chemotherapy. Moreover, these treatments would favor the emergence of these CSCs and the reprogramming of non-CSCs in CSCs. It has been demonstrated in neoadjuvant that the proportion of CSCs before any treatment is correlated with chemoresistance and that a resurgence of CSCs after chemotherapy is correlated with a poor prognosis. However, the mechanisms involved in the emergence of CSCs by reprogramming of non-CSCs are not yet known. The Oscar Lambret Center proposes a monocentric prospective interventional study based on the cellular and molecular analysis of the tumor, serum and circulating cells, before, during and at the end of the treatment for each patient receiving a neoadjuvant chemotherapy for breast cancer. The identification of the mechanisms contributing to the enrichment of CSCs resistant to chemotherapy could lead to therapeutic solutions.

Conditions

Breast Cancer

Keywords

Cancer Stem Cells

Outcome Measures

Primary Outcomes (1)

• Complete histopathological response

  Complete histopathological response as classified by Sataloff according to the rate of CSCs before treatment.

  1 month after surgery

Secondary Outcomes (7)

• Evaluation of the expression of genes involved in reprogramming by immunohistochemistry and Reverse Transcription Polymerase Chain Reaction (RT-PCR) according to the rate of CSCs before, during and after chemotherapy.

  Baseline

• Evaluation of the expression of genes involved in reprogramming by immunohistochemistry and Reverse Transcription Polymerase Chain Reaction (RT-PCR) according to the rate of CSCs before, during and after chemotherapy.

  After 3 cycles (cycle length = 21 days) of chemotherapy

• Evaluation of the expression of genes involved in reprogramming by immunohistochemistry and Reverse Transcription Polymerase Chain Reaction (RT-PCR) according to the rate of CSCs before, during and after chemotherapy.

  Within a month after surgery

• Evaluation of relapse-free survival

  1 month after surgery

• Quantification of the frequency of Cancer Stem Cells (CSCs) among the population of Circulating Tumor Cells (CTCs).

  Baseline

Study Arms (1)

Biological collection

EXPERIMENTAL

Before, during and after their treatment by chemotherapy, patients will undergo laboratory examinations.

Procedure: Biological collection

Interventions

Biological collection PROCEDURE

Collection of blood samples and tumor specimens : Biological collection before treatment : * 1 tumor specimen (under echographic control) * 4 blood collections Biological collection during treatment : * 1 tumor specimen after 3 cycles * 4 blood collections after 3 and 6 cycles

Biological collection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18
• With a mammary adenocarcinoma histologically proven
• Who cannot benefit from a first-conserving surgery or with aggressiveness criteria on the initial biopsy (triple negative tumor, grade III histoprognostic, high Ki67, HER2 overexpressed) after presentation in multidisciplinary meeting.
• Absence of prior chemotherapy.
• Requiring a neoadjuvant chemotherapy with anthracyclines and taxanes selected in multidisciplinary meeting.
• Informed consent signed by the patient before the implementation of any specific procedure to the study.

You may not qualify if:

• Metastatic disease. The extension work-up is carried out according to the reference system of the participating center.
• Other histological type.
• Patient refusing the conservation of samples.
• Patient included in a clinical trial protocol with an experimental molecule (during this study).

Sponsors & Collaborators

• Institut pour la Recherche sur le Cancer de Lille: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre Oscar Lambret: lead

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Géraldine LAURIDANT, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 7, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: October 6, 2020
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)