Breast CancerMACSSINCT03870802
MACSSI (MAstectomie Cellules Souches Surveillance Immunitaire)
An observational study of Breast Cancer, run by Centre Leon Berard at 1 site in France.
Trial summary
Monocentric, observational and prospective study in adult women having an early-stage breast cancer without genetic risk. The main objective is to characterize quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland in… 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?
- Characterization of breast stem & immune system cells infiltrated in the mammary gland
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2021to 15 Nov 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adult women having an early-stage breast cancer without genetic risk requiring a breast surgery
Who may be able to join
- Age ≥ 18 years
- Patient requiring a breast surgery (total mastectomy) of an early stage tumour classified as :
- Luminal A (Arm A) : Patients with a moderate risk of breast cancer progression or,
- Luminal B or Basal (Arm B) : Patients with a high risk of breast cancer progression
- Systemic treatment not initiated
- Breast cup size ≥ C
- Informed and signed consent.
Who cannot join
- Neo-adjuvant chemotherapy or hormonotherapy
- History of breast irradiation
- Pregnant or breastfeeding woman
- Patient under tutorship or curatorship
- Patient who underwent a lumpectomy with a level-2 oncoplastic surgery (ex: breast reduction with an inverted-T remodeling)
- Any other prior anti-tumor treatment
- Other medical pathology which may interfere with the biologic evaluation, especially chronic auto-immune diseases.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Léon Bérard
Lyon, 69008
DELAY Emmanuel, MD, +33 4.78.78.51.29, delay.emmanuel@lyon.unicancer.fr
DAMMACCO Maria-Adele, MD, +33 4.78.78.27.76, maria-adele.dammacco@lyon.unicancer.fr
About this study
Official title: Evaluation of Stem and Immune Cells in the Early Stage Breast Cancer Without Genetic Risk
Monocentric, observational and prospective study in adult women having an early-stage breast cancer without genetic risk.
The main objective is to characterize quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland in women:
- With a moderate risk of breast cancer progression (women with an early "Luminal A" tumor) = Group A.
- With a high risk of breast cancer progression (women with an early "Luminal B" or basal tumor) = Group B.
Read the detailed description
Breast cancer is one of the most frequent and the second cause of mortality for women in the world. Breast is a complex organ which has several changes (puberty, pregnancy and menopause). These modifications are controlled by numerous signals as those transmitted by the oestrogens. They are possible through the presence of stem cells in the mammary gland which are able to reply to these signals and can be the target of alterations leading to cancer cells occurence. Breast tumors are composed of complex entities of different kinds of cancer and normal cells which constitute the tumor micro-environment including the immune system cells. This micro-environment transmits a lot of signals to cancer cells and particularly stem cells which can contribute to their survival, the tumor progression and interfere with the treatments efficacy.
The detection of the major deregulation of BMP2 synthesis by mammary micro-environment cells may be a reliable and early biomarker of carcinogens exposure and an indicator of a high risk of developing a luminal type breast cancer.
The immune micro-environment, which has an impact on solid cancer patients' survival, should be taken into consideration for new therapeutic strategies.
Some infiltrating tumour immune cells, as macrophages (TAM) or regulating T and B cells, have shown their key role in tumour escape and metastases apparition. It is relevant to associate the evaluation of immune infiltrate to the breast stem cells in early stage tumours since the literature suggests a functional interaction of these two cellular compartments, particularly in the glioblastoma and the prostate cancer. It seems that mammary stem cells are a major element in the comprehension of breast carcinogenesis but also in the possibilities of repairing the mammary tissue controlling the mammary carcinogenesis.
It is fundamental to clarify the role of stem cells and immunity. Our hypothesis is that breast stem cells are altered in women having a high risk of cancer progression. They would be responsible for a reduced activity of cellular repair and/or contribute to tumour development.
MACSSI project consists in isolating, quantifying and characterizing the breast stem cells and the isolated immune cells of samples obtained for the prophylactic mastectomy in women presenting different tumour progression risks.
The results will be compared to normal samples already collected in women who had a breast reduction.
- Conditions
- Breast Cancer
- Being tested
- Characterization of breast stem & immune system cells infiltrated in the mammary gland
- Keywords
- Breast cancer, Stem cells, Immune 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.
Characterization of breast stem & immune system cells infiltrated in the mammary glandOther
Isolation, quantification and characterization of breast stem and immune cells of samples obtained during the prophylactic mastectomy in women presenting different tumor progression risks.
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterise quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland according to the risk of breast cancer progression (group A and B)
Rate of stem and immune cells and phenotype analysis
Measured: Within one month after inclusion (date of surgery)
Secondary outcomes (6)
Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B
Functional test: mammosphere
Measured: Within one month after inclusion (date of surgery)
Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B
Functional test: TDLU
Measured: Within one month after inclusion (date of surgery)
Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B
Functional test: E-CFC - FACS
Measured: Within one month after inclusion (date of surgery)
Determination of the stem cells role in the cellular regulation and repair activity
Functional tests
Measured: Within one month after inclusion (date of surgery)
Determination of the efficacy of the immune systems cells found in the samples in the early stage of breast tumorigenesis
FACS
Measured: Within one month after inclusion (date of surgery)
Evaluation of the role of breast stem and immune cells in the early stage development of a breast cancer: risk or protective factor ?
Functional tests: mammosphere, TDLU, E-CFC - FACS
Measured: Within one month after inclusion (date of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start22 Feb 2021
- Primary completion22 Feb 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
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.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DELAY Emmanuel, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870802
- Sponsor's protocol ID
- MACSSI (ET18-150)
- Acronym
- MACSSI
- Status last verified
- Jan 2024
- First submitted
- 25 Sep 2018
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stem and Immune Cells in the Early Stage Breast Cancer Without Genetic Risk
- ClinicalTrials.gov ID
- NCT03870802
- Acronym / sponsor ID
- MACSSI / MACSSI (ET18-150)
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Stem cells, Immune cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 22 Feb 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 12 Mar 2019 (actual)
- 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.
Monocentric, observational and prospective study in adult women having an early-stage breast cancer without genetic risk.
The main objective is to characterize quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland in women:
- With a moderate risk of breast cancer progression (women with an early "Luminal A" tumor) = Group A.
- With a high risk of breast cancer progression (women with an early "Luminal B" or basal tumor) = Group B.
Detailed description
Breast cancer is one of the most frequent and the second cause of mortality for women in the world. Breast is a complex organ which has several changes (puberty, pregnancy and menopause). These modifications are controlled by numerous signals as those transmitted by the oestrogens. They are possible through the presence of stem cells in the mammary gland which are able to reply to these signals and can be the target of alterations leading to cancer cells occurence. Breast tumors are composed of complex entities of different kinds of cancer and normal cells which constitute the tumor micro-environment including the immune system cells. This micro-environment transmits a lot of signals to cancer cells and particularly stem cells which can contribute to their survival, the tumor progression and interfere with the treatments efficacy.
The detection of the major deregulation of BMP2 synthesis by mammary micro-environment cells may be a reliable and early biomarker of carcinogens exposure and an indicator of a high risk of developing a luminal type breast cancer.
The immune micro-environment, which has an impact on solid cancer patients' survival, should be taken into consideration for new therapeutic strategies.
Some infiltrating tumour immune cells, as macrophages (TAM) or regulating T and B cells, have shown their key role in tumour escape and metastases apparition. It is relevant to associate the evaluation of immune infiltrate to the breast stem cells in early stage tumours since the literature suggests a functional interaction of these two cellular compartments, particularly in the glioblastoma and the prostate cancer. It seems that mammary stem cells are a major element in the comprehension of breast carcinogenesis but also in the possibilities of repairing the mammary tissue controlling the mammary carcinogenesis.
It is fundamental to clarify the role of stem cells and immunity. Our hypothesis is that breast stem cells are altered in women having a high risk of cancer progression. They would be responsible for a reduced activity of cellular repair and/or contribute to tumour development.
MACSSI project consists in isolating, quantifying and characterizing the breast stem cells and the isolated immune cells of samples obtained for the prophylactic mastectomy in women presenting different tumour progression risks.
The results will be compared to normal samples already collected in women who had a breast reduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult women having an early-stage breast cancer without genetic risk requiring a breast surgery
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patient requiring a breast surgery (total mastectomy) of an early stage tumour classified as :
- Systemic treatment not initiated
- Breast cup size ≥ C
- Informed and signed consent.
Key exclusion criteria (7 listed)
- Neo-adjuvant chemotherapy or hormonotherapy
- History of breast irradiation
- Pregnant or breastfeeding woman
- Patient under tutorship or curatorship
- Patient who underwent a lumpectomy with a level-2 oncoplastic surgery (ex: breast reduction with an inverted-T remodeling)
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 |
|---|---|---|
| Characterization of breast stem & immune system cells infiltrated in the mammary glandIsolation, quantification and characterization of breast stem and immune cells of samples obtained during the prophylactic mastectomy in women presenting different tumor progression risks. | Other | – |
Primary outcome
To characterise quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland according to the risk of breast cancer progression (group A and B)
Time frame: Within one month after inclusion (date of surgery)
Rate of stem and immune cells and phenotype analysis
6 secondary outcomes
Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B
Time frame: Within one month after inclusion (date of surgery)
Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B
Time frame: Within one month after inclusion (date of surgery)
Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B
Time frame: Within one month after inclusion (date of surgery)
Determination of the stem cells role in the cellular regulation and repair activity
Time frame: Within one month after inclusion (date of surgery)
Determination of the efficacy of the immune systems cells found in the samples in the early stage of breast tumorigenesis
Time frame: Within one month after inclusion (date of surgery)
Evaluation of the role of breast stem and immune cells in the early stage development of a breast cancer: risk or protective factor ?
Time frame: Within one month after inclusion (date of surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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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.
DELAY Emmanuel, MD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Leon Berard 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DELAY Emmanuel, MD (+33 4.78.78.51.29, emmanuel.delay@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterise quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland according to the risk of breast cancer progression (group A and B) (time frame: Within one month after inclusion (date of 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 25 Jan 2024.