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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00131924 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: esterified estrogens |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies |
Study Start Date: | March 2004 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Documented disease progression
Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer
Brain metastases allowed provided both of the following criteria are met:
Hormone receptor status
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, as defined by any of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611-3013 |
Principal Investigator: | William J. Gradishar, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000437793, NU-03B5 |
Study First Received: | August 16, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00131924 |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IV breast cancer |
Estrogens, Esterified (USP) Skin Diseases Breast Neoplasms |
Breast Diseases Recurrence Estrone |
Estrogens Neoplasms Neoplasms by Site Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |