NCT05007379

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Nov 2021Dec 2027

First Submitted

Initial submission to the registry

August 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

August 11, 2021

Last Update Submit

March 16, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Antitumor activity of the CAR-macrophages against organoids from HER2 negative, HER2 low and HER2 positive breast cancers

    Measurement of the phagocytic capacity

    24 months

  • Antitumor activity of the CAR-macrophages compared to non-modified macrophages

    Measurement of the phagocytic capacity

    24 months

Secondary Outcomes (1)

  • Antitumor activity of the CAR-macrophages against organoids from early and advanced breast cancers patients

    24 months

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a cohort study conducted in breast cancer patients requiring a surgery or a tumor biopsy as part of their care.

You may qualify if:

  • 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

You may not qualify if:

  • Opposed to biospecimen collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oscar Lambret Center

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Nawale HAJJAJI, MD PhD

CONTACT

+33 320295910n-hajjaji@o-lambret.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 16, 2021

Study Start

November 2, 2021

Primary Completion

September 1, 2023

Study Completion (Estimated)

December 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

FR(1)