A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer
- 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
- 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
- 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:
- 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.