Expired Study
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Chicago, Illinois 60611


Purpose:

RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy. PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.


Study summary:

OBJECTIVES: Primary - Determine the clinical response rate in postmenopausal women with estrogen and/or progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens (Menest^®). Secondary - Determine time to disease progression in patients treated with this drug. - Determine the toxic effects of this drug in these patients. OUTLINE: Patients receive oral high-dose esterified estrogens (Menest^®) 3 times daily. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 2 months. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Metastatic disease - Documented disease progression - Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer - Disease progression during adjuvant tamoxifen is considered 1 prior therapy - The 2 most recent treatments must have been endocrine agents - At least 1 objective measurable disease parameter - Brain metastases allowed provided both of the following criteria are met: - Brain metastases were previously treated AND are currently stable - Brain metastases are not the only site of metastatic disease - Hormone receptor status - Estrogen and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Postmenopausal, as defined by any of the following: - At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months - At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range - Under 50 years of age and FSH level within postmenopausal range - Prior bilateral oophorectomy Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - Adequate hematologic function Hepatic - Adequate hepatic function - Bilirubin ≤ 1.5 times upper limit of normal - No history of hepatic adenoma Renal - Adequate renal function - No history of hypercalcemia or severe hypocalcemia Cardiovascular - No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use - No active thrombophlebitis or thromboembolic disorders - No history of uncontrolled hypertension Other - Not pregnant - No undiagnosed abnormal vaginal bleeding - No other serious medical illness - No psychiatric illness that would preclude giving informed consent - No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Prior chemotherapy for metastatic disease allowed - Prior adjuvant chemotherapy allowed Endocrine therapy - See Disease Characteristics Radiotherapy - Prior radiotherapy allowed provided the only site of measurable disease was not irradiated Surgery - Not specified


NCT ID:

NCT00131924


Primary Contact:

Principal Investigator
William J. Gradishar, MD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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