Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.

Breast Cancer Clinical Trial

— CARMMYC  

Official title:

Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818125
• Other study ID #: 21 SEIN 01
• Status: Completed
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: September 2022
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Patients with breast cancer (stage I, II III or IV)
Blood samples will be collected at different times: at Baseline for all patients with breast cancer: before initiation of treatment (i.e. before initiation of planned treatment for stage I to III patients and before any new line of treatment for stage IV patients); at the time of disease progression (or at 12 months in absence of progression) for patients with metastatic breast cancer (stage IV) For each patient a tumor sample from the initial diagnosis of the disease (i.e. primary tumor +/- biopsy of a metastasis) will be collected (archived tumor block) for the study.

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		20 months after the study start
Secondary	Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.		20 months after the study start
Secondary	Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.		20 months after the study start