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

This study is currently recruiting participants.
Verified March 2017 by AC Camargo Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02941536
First Posted: October 21, 2016
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
International Atomic Energy Agency
Information provided by (Responsible Party):
AC Camargo Cancer Center
  Purpose
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.

Condition Intervention
Brain Cancer Breast Cancer Diagnostic Test: Circulating tumor cells evaluation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Evaluation of Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Stereotactic Radiotherapy for Encephalic Metastases of Breast Cancer

Resource links provided by NLM:


Further study details as provided by AC Camargo Cancer Center:

Primary Outcome Measures:
  • Brain progression-free survival [ Time Frame: 1 year ]
    Local and distant brain progression


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 1 year ]

Estimated Enrollment: 40
Actual Study Start Date: November 1, 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Circulating Tumor Cells and Radiotherapy
Circulating tumor cells evaluation 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
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941536


Contacts
Contact: Douglas G Castro, MD, MSc 55 11 2189 5000 ext 5104 dougguedes@uol.com.br
Contact: Ludmilla T Chinen, PhD 55 11 2189 5000 ext 2276 ltdchinen@gmail.com

Locations
Brazil
AC Camargo Cancer Center Recruiting
São Paulo, SP, Brazil, 01509-900
Contact: Douglas G Castro, MD, MSc    55 11 2189 5104    dougguedes@uol.com.br   
Contact: Ludmilla T Chinen, PhD    55 11 2189 5000 ext 2776    ltdchinen@gmail.com   
Sponsors and Collaborators
AC Camargo Cancer Center
International Atomic Energy Agency
Investigators
Principal Investigator: Douglas G Castro, MD, MSc AC Camargo Cancer Center
  More Information

Responsible Party: AC Camargo Cancer Center
ClinicalTrials.gov Identifier: NCT02941536     History of Changes
Other Study ID Numbers: 2258/16
First Submitted: October 20, 2016
First Posted: October 21, 2016
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by AC Camargo Cancer Center:
Circulating Tumor Cells
Stereotactic Radiosurgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Brain Neoplasms
Brain Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Central Nervous System Diseases
Nervous System Diseases