Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids (CARMA)
Overview
Cell-based immune therapy using modified macrophages is a promising therapeutic approach in breast cancer. The objective of this cohort study is to collect tumor samples to develop patients' derived organoids to test the antitumor activity of newly developed CAR-macrophages. Other biological samples will be collected such as blood to analyze the host inflammatory status.
Primary outcome measures
- Antitumor activity of the CAR-macrophages against organoids from HER2 negative, HER2 low and HER2 positive breast cancers [Time frame: 24 months]
- Antitumor activity of the CAR-macrophages compared to non-modified macrophages [Time frame: 24 months]
Secondary outcome measures (1)
- Antitumor activity of the CAR-macrophages against organoids from early and advanced breast cancers patients [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Male or female aged 18 years or more
- Histologically confirmed breast cancer at any stage
- Requiring surgery or tumor biopsy as standard of care
- Any or no systemic treatment
- Signed informaed consent
- Health insurance coverage
Exclusion criteria
- Opposed to biospecimen collection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Oscar Lambret Center — Lille
Identifiers
NCT: NCT05007379 · CARMA-2101 · 2021-A00670-41