This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in combination with Ixabepilone for women with triple negative metastatic breast cancer.
Ixabepilone is a FDA approved drug for the treatment of metastatic or locally advanced breast cancer after failure of chemotherapy. SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of treatments with a high degree of precision within the body. The combination of Ixabepilone with SBRT is not an approved treatment at this time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
injection
SBRT will begin between 1 and 5 weeks after the initiation of Ixabepilone. Patients will receive one, three, or five fractions.
University of Texas Southwestern
Dallas, Texas, United States
The effect of SBRT in combination with Ixabepilone on median progression free survival
To evaluate the effect of SBRT in combination with Ixabepilone on median progression free survival. Progression free survival is defined as time from initiation of treatment to progressive disease or death
Time frame: 5 years
In-field local control and out-of field disease progression rates
To describe the in-field local control and out-of field disease progression rates
Time frame: 5 years
Safety of SBRT in combination with Ixabepilone for patients with metastatic triple negative breast cancer after prior chemotherapy
Evaluate the safety of SBRT in combination with Ixabepilone for patients with metastatic triple negative breast cancer after prior chemotherapy
Time frame: 1 year
The duration of Ixabepilone usage and time to initiation of next line systemic agent (chemotherapy or biologic agent)
Evaluate the duration of Ixabepilone usage and time to initiation of next line systemic agent (chemotherapy or biologic agent)
Time frame: 5 year
Overall survival for patients with metastatic triple negative breast treated with SBRT in combination with Ixabepilone
Evaluate overall survival for patients with metastatic triple negative breast treated with SBRT in combination with Ixabepilone
Time frame: 5 year
Generation of an immune response to tumor cells
Evaluate generation of an immune response to tumor cells
Time frame: 1 year
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