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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941536
• Other study ID #: 2258/16
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: October 30, 2018

Study information

• Verified date: December 2018
• Source: AC Camargo Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Diseases
• Brain Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplastic Cells, Circulating

Intervention

Diagnostic Test:
• Circulating 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.

Locations

Country	Name	City	State
Brazil	AC Camargo Cancer Center	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
AC Camargo Cancer Center	International Atomic Energy Agency

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain progression-free survival	Local and Distant brain progression	6 months
Secondary	Overall survival		6 months