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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Anastrozole

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