Stage IV Breast Cancer Clinical Trial
Official title:
A Phase II Clinical Trial of 17-Allyamino-17-Demethoxygeldanamycin (17-AAG) in Chemotherapy Refractory Metastatic Breast Cancer
This phase II trial is studying how well tanespimycin works in treating women with refractory locally advanced or metastatic breast cancer. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die
PRIMARY OBJECTIVES:
I. To determine the response rate of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG)
(tanespimycin) in patients with refractory/resistant metastatic breast cancer.
II. To determine the progression free survival (PFS) of patients with refractory/resistant
metastatic breast cancer when treated with 17-AAG.
III. To correlate patients' her2/neu status with response to 17-AAG treatment.
OUTLINE: This is a multicenter study.
Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at day 30, every 10-12 weeks until disease progression, and then every
3 months thereafter.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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