The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not previously responded to Herceptin
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Solution, IV, Weekly two hour infusion, 4-cycles until disease progression or DLT This is a one-arm study with 4 fixed doses of Tanespimycin (225mg/m2, 300mg/m2, 375mg/m2 and 400mg/m2)
Premiere Oncology Of Arizona
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Objective tumor response rate (RECIST complete response, or partial response ) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Time frame: 3-6 months
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Time frame: 6-12 months
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Time frame: 12 months
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