Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-02 @ 12:52 PM
Study NCT ID:
NCT00244959
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2005-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA006973 | NIH | None | https://reporter.nih.gov/quic… | View |
| JHOC-J0365 | OTHER | SKCCC at Johns Hopkins | View | |
| JHOC-SKCCC-J0365 | OTHER | SKCCC at Johns Hopkins | View |