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

March 16, 2026 updated by: Centre Oscar Lambret

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients responding criteria for selection will sign an informed consent form.

Before the initiation of chemotherapy, a tumor specimen (under echographic control) and four blood samples will be collected. The chemotherapy consists of 3 cycles of (F)EC100 spaced 21 days apart :

  • Epirubicin, 100 mg/m² in intravenous (IV)
  • Cyclophosphamide, 500 mg/m² in IV
  • +/- 5-fluorouracile (5FU), 500 mg/m² in IV

Followed by 3 cycles of Taxotere (Docetaxel, IV, 100 mg/m²) spaced 21 days apart +/- Herceptin (Trastuzumab, IV, 8 mg/kg during C1 and then 6 mg/kg) for 1 year in the case of overexpression of the HER-2 oncoprotein.

After 3 cycles of chemotherapy (that is to say at the end of the (F)EC100 treatment, at the time of the usual ultrasound examination), a tumor specimen and four blood samples will be taken. After 6 cycles of chemotherapy (that is to say at the end of the Docetaxel +/- Trastuzumab treatment), four blood samples will be collected. A partial or total mastectomy could be performed during the 6 cycles of chemotherapy. During surgery, a tumor specimen will be taken. The indication of breast surgery will remain at the discretion of the pluridisciplinary committee of the participating center.

Prior to the start of treatment, patients will have a clinical and a paraclinical examination and will undergo laboratory examinations. On day 1 of the fourth cycle and after the sixth cycle of chemotherapy, patients will have a clinical examination and will undergo laboratory examinations. After three cycles of chemotherapy, at the time of the intermediate breast ultrasound, patients will have paraclinical examinations. Finally, at the end of the study (after partial or total mastectomy), anatomopathological examinations will be performed on the operative specimen.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Biological collection
Before, during and after their treatment by chemotherapy, patients will undergo laboratory examinations.
Procedure: Biological collection

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete histopathological response
Time Frame: 1 month after surgery
Complete histopathological response as classified by Sataloff according to the rate of CSCs before treatment.
1 month after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline
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.
Time Frame: After 3 cycles (cycle length = 21 days) of 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.
Time Frame: Within a month after surgery
Within a month after surgery
Evaluation of relapse-free survival
Time Frame: 1 month after surgery
Evaluation of relapse-free survival, defined as the elapsed time between the date of diagnosis and the date of appearance of a local or distant recurrence.
1 month after surgery
Quantification of the frequency of Cancer Stem Cells (CSCs) among the population of Circulating Tumor Cells (CTCs).
Time Frame: Baseline
Baseline
Quantification of the frequency of Cancer Stem Cells (CSCs) among the population of Circulating Tumor Cells (CTCs).
Time Frame: After 3 cycles (cycle length = 21 days) of chemotherapy
After 3 cycles (cycle length = 21 days) of chemotherapy
Quantification of the frequency of Cancer Stem Cells (CSCs) among the population of Circulating Tumor Cells (CTCs).
Time Frame: After 6 cycles (cycle length = 21 days) of chemotherapy
After 6 cycles (cycle length = 21 days) of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Oscar Lambret

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
Institut pour la Recherche sur le Cancer de Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Géraldine LAURIDANT, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RepriM-1407
  • 2014-AO1806-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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