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

NCT02941536 | Completed

• 1 other identifier: 2258/16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Cancer; Breast Cancer

Keywords

Circulating Tumor Cells; Stereotactic Radiosurgery

Outcome Measures

Primary Outcomes (1)

• Brain progression-free survival

  Local and Distant brain progression

  6 months

Secondary Outcomes (1)

• Overall survival

  6 months

Study Arms (1)

Circulating Tumor Cells and Radiotherapy

OTHER

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

Interventions

Circulating tumor cells evaluation DIAGNOSTIC_TEST

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

Circulating Tumor Cells and Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AC Camargo Cancer Center: lead
• International Atomic Energy Agency: collaborator

Study Sites (1)

AC Camargo Cancer Center

São Paulo, São Paulo, 01509-900, Brazil

Location

MeSH Terms

Conditions

Brain Neoplasms; Breast Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas G Castro, MD, MSc

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 21, 2016
• Study Start: November 1, 2016
• Primary Completion: October 15, 2018
• Study Completion: October 30, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months after article publication
• Access Criteria: Correlated Area Investigators with publishing background and a defined objective.

Locations

BR (1)