Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer

Study Overview
=================
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.

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.

Official Title
-----------------
Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: anastrozole
* Procedure: adjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer meeting 1 of the following criteria: Ductal carcinoma in situ (DCIS) Invasive carcinoma Stage I-III disease Must have undergone breast cancer surgery within the past 6 months, including any of the following: Mastectomy or lumpectomy with or without radiation Sentinel node and/or axillary node dissection Re-excision of lumpectomy margins Intact contralateral breast No prior radiation therapy or mastectomy Prior biopsies allowed Hormone receptor status: Estrogen and/or progesterone receptor-positive tumor by immunohistochemical staining PATIENT CHARACTERISTICS: Sex Female Menopausal status Postmenopausal, defined as 1 of the following: At least 60 years of age Less than 60 years of age and amenorrheic ≥ 12 months prior to study entry Less than 60 years of age, amenorrheic for < 12 months prior to day 1, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Less than 60 years of age, without a uterus, and LH and FSH values within postmenopausal range Underwent prior bilateral oophorectomy Underwent prior radiation castration AND amenorrheic for ≥ 6 months Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Chemotherapy No prior or concurrent adjuvant chemotherapy for breast cancer Endocrine therapy No prior aromatase inhibitor At least 6 weeks since prior and no concurrent tamoxifen At least 6 weeks since prior and no concurrent hormone replacement therapy Concurrent low-dose, local vaginal estrogen in the form of either a conjugated estrogen ring or other similar product (e.g., Estring® or Vagifem®) allowed At least 6 weeks since prior and no other concurrent selective estrogen receptor modulators (e.g., raloxifene) Radiotherapy See Disease Characteristics Surgery See Disease Characteristics No contralateral breast implant Other Concurrent bisphosphonates allowed at the discretion of the treating oncologist No concurrent consumption of soy supplements Concurrent routine dietary consumption of soy-containing foods allowed No other concurrent investigational or commercial drugs or therapies for the treatment of DCIS or invasive breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anastrozole<br>Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer | Drug: anastrozole<br>* 1 mg orally daily for 12 months<br>* Other names: Arimidex;Procedure: adjuvant therapy<br>* treatment received after breast cancer surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in breast density after 12 months of treatment |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hormone levels after 12 months of treatment |  | 12 months | 
| Comparison between change in breast density with change in hormone levels after 12 months of treatment |  | 12 months | 
| Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment |  | 12 months | 
| Comparison between change in bone density with change in hormone levels after 12 months of treatment |  | 12 months | 
| Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, ductal breast carcinoma in situ, breast cancer in situ