Estrogen for Triple Negative Breast Cancer

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Cancer Institute (NCI)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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:

Exclusion Criteria:

• 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.