Breast Cancer Clinical Trial
Official title:
A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer
Chemoprevention is the use of certain drugs to keep cancer from forming. The use of atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying the best dose of atorvastatin in preventing breast cancer in women at increased risk for breast cancer.
PRIMARY OBJECTIVES:
I. To determine the minimum biological effective dose (MBED) of atorvastatin required to
induce modulation in the proliferation marker, Ki-67, in breast tissue of women who are at
high risk to develop breast cancer. We will evaluate pre- and post atorvastatin treatment (4
dose levels) expression of Ki-67 in samples obtained via FNA from breast tissue of women at
high risk for breast cancer. This specific aim tests the hypothesis that treatment with
atorvastatin will induce a decrease in Ki-67.
SECONDARY OBJECTIVES:
I. To evaluate atorvastatin induced modulation of breast cancer biomarkers markers (EGFR,
P-EGFR, ER, p21, p27, bcl-2, CC3, cytology) and drug related markers (LXR, total
cholesterol, LDL, HDL, CRP) in women who are at high risk to develop breast cancer.
II. To determine plasma and tissue levels of atorvastatin and two of its hydroxylated
metabolites (ohydroxyatorvastatin and p-hydroxyatorvastatin) in women who are treated with
atorvastatin and to correlate these levels with Ki-67 levels. III. To correlate changes in
Ki-67 and the above-described panel of biomarkers with HMG-CoA reductase genotype.
OUTLINE: Participants are randomized to 1 of 4 arms.
ARM I: Participants receive oral atorvastatin once daily for 3 months.
ARM II: Participants receive oral atorvastatin (at a higher dose than in arm I) once daily
for 3 months.
ARM III: Participants receive oral atorvastatin (at a higher dose than in arm II) once daily
for 3 months.
ARM IV: Participants do not receive treatment. Participants undergo blood sample collection
and fine needle aspiration of breast tissue at baseline and at 3 months for correlative
biomarker studies.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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