Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Invasive Ductal Breast Carcinoma With Predominant Intraductal Component
- Central Nervous System Metastases
- Invasive Ductal Breast Carcinoma
- Invasive Lobular Breast Carcinoma
- Invasive Lobular Breast Carcinoma With Predominant in Situ Component
- Tubular Ductal Breast Carcinoma
- Liver Metastases
- Recurrent Breast Cancer
- Lobular Breast Carcinoma In Situ
- Lung Metastases
- Male Breast Cancer
- Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate
- Tumors Metastatic to Brain
- Mucinous Ductal Breast Carcinoma
- Papillary Ductal Breast Carcinoma
- Stage IV Breast Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate the feasibility of correlating changes in the number of circulating tumor cells in metastatic breast cancer patients with time to progression following hypofractionated image guided radiotherapy to all known sites (=< 5) of disease. SECONDARY OBJECTIVES: I. To dete...
PRIMARY OBJECTIVES: I. To evaluate the feasibility of correlating changes in the number of circulating tumor cells in metastatic breast cancer patients with time to progression following hypofractionated image guided radiotherapy to all known sites (=< 5) of disease. SECONDARY OBJECTIVES: I. To determine the progression free survival, overall survival, pattern of failure, and toxicity of hypofractionated image guided radiotherapy to all active sites (=< 5) of metastatic disease. II. To assess the feasibility of the Interferon-Related DNA Damage Resistance Gene Signature (IRDS) for its predictive value in treatment failure, both in and out of the radiation field. OUTLINE: Patients with metastases in the lung, liver, abdomen, and extremities undergo 10 fractions or less of hypofractionated radiation therapy and patients with brain metastases undergo a single fraction of stereotactic radiosurgery. After completion of study treatment, patients are followed up every 2 weeks for 2 months, at 3 months, every 3 months for a year, and then every 6 months thereafter.
Tracking Information
- NCT #
- NCT01706432
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Steven Chmura University of Chicago
Get Well Soon