MACSSI (MAstectomie Cellules Souches Surveillance Immunitaire) (MACSSI)

  • End date
    Nov 15, 2024
  • participants needed
  • sponsor
    Centre Leon Berard
Updated on 7 October 2022
breast surgery


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.


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.

Condition Breast Cancer
Treatment Characterization of breast stem & immune system cells infiltrated in the mammary gland
Clinical Study IdentifierNCT03870802
SponsorCentre Leon Berard
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note