Breast Cancer Clinical Trial
Official title:
Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who
have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III
breast cancer.
OBJECTIVES:
Primary
- Determine the 12-month change in breast density in postmenopausal women with ductal
carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant
anastrozole.
Secondary
- Determine the change in estrone sulfate levels in patients treated with this drug.
- Correlate the change in breast density with the change in circulating estrone sulfate
levels in patients treated with this drug.
- Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the
relationship between wild-type aromatase enzyme with change in breast density and
change in estrone sulfate levels in patients treated with this drug.
- Determine the 12-month change in bone density, and correlate it with the change in
circulating estrone sulfate levels in patients treated with this drug.
- Correlate the reversal of hypermethylation with change in circulating estrone sulfate
levels and breast density in patients treated with this drug.
OUTLINE: This is a pilot study. Patients are stratified according to concurrent
bisphosphonate use (yes vs no).
Patients receive oral anastrozole once daily for up to 12 months in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
;
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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