Phase II Trial Of PS-341 In Metastatic Breast Cancer
I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic
I. Determine the clinical activity of this drug, in terms of progression-free survival, in
II. Determine the toxicity profile and tolerability of this drug in these women.
III. Determine the pharmacodynamics of this drug in these women.
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat
every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response (CR + PR)
The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).
Up to 24 months
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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