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Completed

NCT Number: NCT04818125

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Patient not yet initiated on specific treatment for the stage of breast cancer at inclusion.
  • Available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability.
  • Age ≥ 18 years old.
  • Patient affiliated to a Social Health Insurance in France.
  • Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.

Exclusion criteria

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

Treatment and study plan

Patients with breast cancer (stage I, II III or IV)

Other

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.

Primary outcomes

  1. 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.

    Time frame: 20 months after the study start

Secondary outcomes

  1. Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.

    Time frame: 20 months after the study start

  2. Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.

    Time frame: 20 months after the study start

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: CARMMYC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2021
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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