In This SectionTexas Health Research & Education Institute
Disease or Condition
A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma in SITU (DCIS) Undergoing Lumpectomy with Radiation Therapy. (Breast Cancer)
Many women with noninvasive breast cancer receive the drug tamoxifen to help prevent their cancer from progressing to invasive cancer (cancer cells have spreading outside of the breast ducts into other breast tissue or other parts of the body). This study is being done to find out whether the drug anastrozole is as good as or better than tamoxifen at preventing invasive breast cancer from occurring. This study also will compare the effects of anastrozole and tamoxifen.
Documentation of informed consent.
Life expectancy of at least 10 years, excluding her diagnosis of breast cancer.
Postmenopausal at the time of randomization.
The tumor must be ductal carcinoma in situ (DCIS). Patients with mixed DCIS and lobular carcinoma in situ [LCIS] are eligible.)
The DCIS must be ER-positive or PgR-positive.
The margins of the resected specimen must be free of DCIS.
Patients with sentinel node biopsy or axillary dissection are eligible as long as the nodes are pathologically negative.
The interval between the last surgery for breast cancer treatment and randomization must be less than or equal to 84 days.
Patients must not be participating in any other clinical trials of therapy for DCIS.
At the time of randomization, white blood cell counts, hepatic function and renal function must be in keeping with standards of good medical care.
Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
Men are not eligible for this study.
Women with one or more of the following conditions also are ineligible for this study:
Patients with invasive (including microinvasive) breast cancer.
Patients with Paget's disease of the nipple.
Patients with DCIS removed by mastectomy.
Patients who have initiated systemic therapy for the current DCIS.
Prior history of invasive breast cancer or DCIS (patients with a history of LCIS are eligible).
Patients with suspicious palpable nodes are considered ineligible unless there is biopsy evidence that these are not involved with tumor.
Patients with one or more ipsilateral axillary or intramammary nodes that are positive for tumor on histologic examination.
Patients in whom the margins of the resected specimen are involved with DCIS.
Previous or current therapy with aromatase inhibitors or tamoxifen for treatment or prevention of any disease.
Current therapy with raloxifene (Evista®) or other selective estrogen receptor modulators (SERMs). (These patients are eligible only if this therapy is discontinued prior to randomization.)
Any sex hormonal therapy, (These patients are eligible only if this therapy is discontinued prior to randomization.)
Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the administration of tamoxifen or anastrozole or would prevent followup for at least 10 years.
Prior history of deep vein thrombosis or pulmonary embolus.
Prior history of documented cerebral vascular accident or documented transient ischemic attack.
Uncontrolled high blood pressure.
Uncontrolled atrial fibrillation.
Current therapy with Coumadin®.
Psychiatric or addictive disorders that would preclude obtaining informed consent.