Characterizing tumor-origin circulating cells in metastatic breast cancer
Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer
This study is trying to see if certain cells in the blood of patients with metastatic breast cancer come from their tumors, which could help us understand how the cancer is progressing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06408038 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to investigate the presence of CK+/CD45+ double-positive circulating cells in patients with metastatic breast cancer. Eligible participants will provide blood samples before starting their anti-tumor treatment, and archived tumor samples will also be collected for analysis. The study will include 60 patients treated at the IUCT-O, focusing on various immunohistochemical subtypes of breast cancer. The goal is to determine whether these circulating cells originate from tumors, which could provide insights into cancer progression.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic breast cancer who are eligible for 1st, 2nd, or 3rd line treatment.
Not a fit: Patients with associated pathologies that may interfere with study procedures or those unable to comply with medical monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of metastatic breast cancer and improve patient monitoring and treatment strategies.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with metastatic breast cancer eligible for 1st, 2nd or 3rd line treatment at stage IV, regardless of immunohistochemical subtype (triple-negative, RH+/HER2-negative or HER2-positive). 2. Patient with metastatic disease or metastatic relapse or progression who has not yet started 1st line treatment for metastatic disease or line 2 or line 3. 3. Tumour sample available (archived tumour block): non-bone metastasis preferred if available or, failing this, primary breast tumour. 4. Age ≥ 18 years and WHO ≤ 2. 5. Patient affiliated to a French Social Security scheme. 6. Patient having signed his/her informed consent prior to inclusion in the study and prior to any specific procedure for the study. Exclusion Criteria: 1. Associated pathology(ies) likely to prevent the study procedure from running smoothly. 2. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and/or procedures set out in the study protocol. 3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice). 4. Patient who has presented with another solid tumour (excluding carcinoma in situ of the breast or cervix) within 5 years. 5. Pregnant patient.
Where this trial is running
Toulouse
- Iuct-O — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Florence DALENC
- Email: dalenc.florence@iuct-oncopole.fr
- Phone: 05 31 15 51 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.