Status:
COMPLETED
Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 tr...
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. Se...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00244959
Start Date
January 1 2004
End Date
November 1 2011
Last Update
March 19 2013
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410