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Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer

Prospective Evaluation of Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Stereotactic Radiotherapy for Encephalic Metastases of Breast Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02941536
Enrollment
40
Registered
2016-10-21
Start date
2016-11-01
Completion date
2018-10-30
Last updated
2018-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer, Breast Cancer

Keywords

Circulating Tumor Cells, Stereotactic Radiosurgery

Brief summary

This study assesses the number of CTCs before and 4-5 weeks after focal stereotactic radiotherapy, in single or fractionated dose, and correlate with the local and distant brain progression-free survival in patients with metastatic breast cancer.

Detailed description

Brain metastases (BM) are the most prevalent tumors of the central nervous system (CNS), with a ratio of 10: 1 relative to primary tumors. In breast cancer, BM are becoming more frequent due to longer life expectancy. Patients with HER2-positive metastatic disease are prone to develop BM more often and they occur in 20 - 40% of cases. Circulating tumor cells (CTC) originate from the primary tumor and can migrate to distant organs. The possible correlation between CTC and the incidence of brain metastases could help define radiotherapy in patients with oligometastatic or not so widespread disease in the brain. However, there are few studies that evaluate these scenarios. Purpose: To assess the number of CTC before and 4-5 weeks after focal stereotactic radiotherapy in single (SRS) or fractionated (SFRT) dose and correlate with the local and distant brain progression free survival in patients with metastatic breast cancer. Potential invasion markers in these cells will be evaluated and correlated with clinical outcome. Patients and Methods: Prospective, single-center research which will be developed at the Radiation Oncology Department of AC Camargo Cancer Center. Patients with diagnosis of metastatic breast cancer to the brain with an indication of focal radiotherapy, SRS or SFRT, will be recruited. The blood will be collected and processed for analysis of CTC by the ISET method (Rarecells, France). The invasion markers (HER-2, COX-2, EGFR, Notch 1 and ST6GALNAC5) will be analyzed on CTC by immunocytochemistry. Expected Results: If our hypothesis is proven, we may include the analysis and quantification of CTC in clinical practice as early indicator of local or distant recurrence in the brain.

Interventions

DIAGNOSTIC_TESTCirculating tumor cells evaluation

Sample collection of circulating tumor cells (CTC) before and 4-5 weeks after focal stereotactic radiotherapy in single (SRS) or fractionated (SFRT) dose.

Sponsors

International Atomic Energy Agency
CollaboratorOTHER_GOV
AC Camargo Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of BM of breast cancer and indication of focal radiotherapy to the brain lesions.

Exclusion criteria

* Patients who received WBRT less than 30 days from the initial CTC dosage. * Patients who received systemic treatment for less than 7 days of the initial CTC dosage. * Pregnant patients.

Design outcomes

Primary

MeasureTime frameDescription
Brain progression-free survival6 monthsLocal and Distant brain progression

Secondary

MeasureTime frame
Overall survival6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026