Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer. (CARMMYC)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Patients with breast cancer (stage I, II III or IV)

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Institut Universitaire du Cancer de Toulouse - Oncopole

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients with breast cancer

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): July 29, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Cancer cell/macrophage hybrid cells; Hybrid cells
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 21 SEIN 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No