Breast CancerRepriMNCT02570100
Research and Analysis of the Mechanisms Involved in the Emergence of Breast Cancer Stem Cells (RepriM)
A study testing Biological collection in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Biological collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to 6 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Biological collection
- Keywords
- Cancer Stem Cells
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Biological collection | Experimental | Before, during and after their treatment by chemotherapy, patients will undergo laboratory examinations. Receives: Procedure: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histopathological response
Complete histopathological response as classified by Sataloff according to the rate of CSCs before treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within a month after surgery
Evaluation of relapse-free survival
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.
Measured: 1 month after surgery
Quantification of the frequency of Cancer Stem Cells (CSCs) among the population of Circulating Tumor Cells (CTCs).
Measured: Baseline
Quantification of the frequency of Cancer Stem Cells (CSCs) among the population of Circulating Tumor Cells (CTCs).
Measured: 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).
Measured: After 6 cycles (cycle length = 21 days) of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2017
- Study completion6 Oct 2020
Why it stopped: The failures of the culture and immunostaining techniques for ALDH do not allow the main objective of the study to be met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Institut pour la Recherche sur le Cancer de Lille
- Responsible party
- Sponsor
- Investigators
- Géraldine LAURIDANT, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570100
- Sponsor's protocol ID
- RepriM-1407
- Other IDs
- 2014-AO1806-41
- Acronym
- RepriM
- Status last verified
- Mar 2026
- First submitted
- 29 Sep 2015
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Analysis of the Mechanisms Involved in the Emergence of Breast Cancer Stem Cells
- ClinicalTrials.gov ID
- NCT02570100
- Acronym / sponsor ID
- RepriM / RepriM-1407
- Conditions
- Breast Cancer
- Keywords
- Cancer Stem Cells
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The failures of the culture and immunostaining techniques for ALDH do not allow the main objective of the study to be met.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Institut pour la Recherche sur le Cancer de Lille
- Study start
- Apr 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological collection | Experimental | Procedure: Biological collectionBefore, during and after their treatment by chemotherapy, patients will undergo laboratory examinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological collectionCollection 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 | Procedure or surgery | Biological collection |
Primary outcome
Complete histopathological response
Time frame: 1 month after surgery
Complete histopathological response as classified by Sataloff according to the rate of CSCs before treatment.
7 secondary outcomes
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
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
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
Evaluation of relapse-free survival
Time frame: 1 month after surgery
Quantification of the frequency of Cancer Stem Cells (CSCs) among the population of Circulating Tumor Cells (CTCs).
Time frame: 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
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
Results and safety
The study was stopped early (reason given: The failures of the culture and immunostaining techniques for ALDH do not allow the main objective of the study to be met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Géraldine LAURIDANT, MD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological collection in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The failures of the culture and immunostaining techniques for ALDH do not allow the main objective of the study to be met.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete histopathological response (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.