I. To assess the anti-tumor activity of estradiol in patients with locally advanced or metastatic triple negative breast cancer (TNBC) that expresses ERbeta (> 25% moderate or strong nuclear staining) and who have prior receipt of taxane and anthracycline based chemotherapy.
I. To examine the safety profile of estradiol when administered at a dose of 2 mg three times daily (tid) to women with locally advanced or metastatic TNBC that expresses ERbeta.
II. To examine the changes in phosphorylated (phospho)-ERbeta, cystatins 1, 2, 4 and 5, phospho-Smad2/3 and Ki-67 in tumor biopsies taken before and after the first cycle of treatment.
I. To examine changes in plasma estradiol, serum cytokine and cystatin levels before/after 1 cycle of estradiol.
II. Analyze the global gene expression profiles of paired biopsies prior to and following 1 cycle of therapy.
III. To develop patient derived xenografts (PDX) that are ERalpha negative, HER2 negative and ERbeta positive (Mayo only).
Patients receive estradiol orally (PO) thrice daily (TID) for days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up annually for 5 years from study registration.
From ClinicalTrials.gov, a database of the U.S. National Institutes of Health, through its National Library of Medicine. This record may not reflect the most current and accurate biomedical/scientific data available from the NLM/NIH.