Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy
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.
Interventional
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in breast density after 12 months of treatment
12 months
No
Vered Stearns, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
J0365 CDR0000446285
NCT00244959
January 2004
November 2011
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |