Status:
TERMINATED
High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 esterif...
Detailed Description
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 endoc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00131924
Start Date
March 1 2004
End Date
January 1 2006
Last Update
June 11 2012
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013