Status:
TERMINATED
Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy
Lead Sponsor:
Georgetown University
Conditions:
Breast Cancer
Cancer of the Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.
Detailed Description
Prior to the current standard of care utilizing estrogen deprivation or antiestrogen therapy to treat hormonally sensitive breast cancers, treatment with pharmacologic doses of estrogen was a common t...
Eligibility Criteria
Inclusion
- Histologically confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer
- Clinically determined evaluable disease
- Post-menopausal woman
- Previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies.
- May have had chemotherapy for adjuvant \&/or metastatic disease.
- May have had radiation therapy but not to the only site of disease.
- Ecog performance status \</= 2.
- Life expectancy of \> 6 months
Exclusion
- Chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial
- Brain metastasis
- Prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus
- Current vaginal bleeding
- Hypercalcemia or hypocalcemia
- History of or active hepatic adenoma
- No other malignancies within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00661531
Start Date
April 1 2008
End Date
June 1 2015
Last Update
April 12 2017
Active Locations (3)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20057
2
Cooper Cancer Institute
Voorhees Township, New Jersey, United States, 08043
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111