Clinical trial NCT04818125: Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.
Official title: Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Cancer cell/macrophage hybrid cells
Hybrid cells
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating cancer cell/macrophage hybrid cells in the peripheral blood.

The study will be conducted on a population of patients with breast cancer (regardless of stage of the disease and the immunohistochemical subtype).

For each included patient, blood samples will be taken and tumor specimens will be collected for the study.

At the end of the blood collection, the patient will have completed his participation in the study.


Eligibility criteria: Inclusion Criteria:

1. Patient with breast cancer of any stage (stage I, II, III or IV) and any immunohistochemical subtype (triple-negative, HR+/HER2-negative or HER2-positive).
2. Patient not yet initiated on specific treatment for the stage of breast cancer at inclusion.
3. Available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability.
4. Age ≥ 18 years old.
5. Patient affiliated to a Social Health Insurance in France.
6. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.

Exclusion Criteria:

1. Associated pathology(ies) that may prevent the proper conduct of the procedure under consideration.
2. Pregnant or breastfeeding woman.
3. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
4. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship protection of justice).
5. Patient who has presented another solid tumor (except breast or cervix carcinoma in situ) within 5 years.

Primary outcomes:
measure: Rate of patients with cancer cell / macrophage hybrid cells in peripheral blood defined as the ratio of the number of patients with hybrid cells to the total number of patients.
timeFrame: 20 months after the study start
Secondary outcomes:
measure: Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.
timeFrame: 20 months after the study start
measure: Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.
timeFrame: 20 months after the study start
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
Study officials:
References: