Estrogen for Triple Negative Breast Cancer
Stopped early · Phase 2
Conditions studied: Female Breast Cancer
In brief
The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.
Key facts
- Study ID
- NCT01083641
- Run by
- University of Wisconsin, Madison
- People needed
- 17
- Starts
- 2010-01-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2019-12-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- histologically or cytologically confirmed breast cancer which is metastatic.
- A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. .
- Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2 negative
- Patients must have measurable disease.
- Eastern Cooperative Oncology Group performance status 0-1.
- Patients with bone metastasis at baseline must agree to treatment with intravenous bisphosphonates
- Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy regimens administered for treatment of their metastatic breast cancer.
- Age >18 years
- Life expectancy of greater than 3 months.
- Patients must have adequate organ and marrow function as defined below:
You may not qualify if…
- systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study
- Patients receiving any other investigational agents for breast cancer treatment.
- Patients with known brain metastases are excluded 3.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol.
- Patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication
- Dysfunctional or post-menopausal vaginal bleeding.
- Uncontrolled hypercalcemia/hypocalcemia
- Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial infarction, deep venous thrombosis or pulmonary embolism.
- History of or active hepatic adenoma.
- Uncontrolled intercurrent illness
- Pregnant women are excluded from this study
- Patients with bone metastasis are excluded if they are unable to receive intravenous bisphosphonate therapy due to the risk for developing hypercalcemia.
Where it is running
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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