Stage IV Breast Cancer Clinical Trial
Official title:
A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy Part B
This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer receiving hormone therapy. Vorinostat may help hormone therapy work better by making tumor cells more sensitive to the drug.
PRIMARY OBJECTIVES:
I. Estimate the rate of clinical benefit (objective response plus stable disease) for
patients treated with 28-day cycles of vorinostat (first 5 consecutive days each week for day
1-21) concurrent with daily aromatase inhibitor (AI) therapy (all 28 days).
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of vorinostat and AI combination therapy in patients
with metastatic breast cancer.
II. Assess the change in estrogen receptor (ER) expression, measured as the change in F-18 16
alpha-fluoroestradiol (FES) standardized uptake value (SUV) using FES positron emission
tomography (PET) completed per protocol 7184 after two weeks of vorinostat and AI therapy and
after 8 weeks of therapy.
III. Assess tumor metabolic response, measured as the change in fludeoxyglucose F 18 (FDG)
SUV using FDG PET completed per protocol 7184 after two weeks of vorinostat and AI therapy
and after 8 weeks of therapy.
IV. Assess the change in hormone levels (estradiol, estrone, follicle-stimulating hormone
[FSH], sex binding globulin, testosterone, and free testosterone) after 8 weeks of therapy.
V. Assess the change in ER, progesterone receptor (PR), human epidermal growth factor
receptor 2 (HER2), androgen receptor (AR), epidermal growth factor receptor (EGFR), vascular
endothelial growth factor (VEGF) tumor expression after two weeks of vorinostat and AI
therapy in patients that consent to optional tissue biopsy procedure.
VI. Assess the time to progression and the overall survival of patients treated with 28-day
cycles of vorinostat (first 5 consecutive days each week for day 1-21) concurrent with daily
AI therapy (all 28 days).
OUTLINE:
Patients receive vorinostat orally (PO) 5 days a week for 3 weeks. Patients also receive AI
therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily
for 4 weeks. Courses repeat every 28 days in the absence of disease progression and
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
then every 6 months until progression, and then annually thereafter.
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