ALLIANCE A011203: A Randomized Phase II Trial of Tamoxifen Versus
Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer
This study is for patients who are post-menopausal with locally advanced or metastatic estrogen receptor positive, HER2 negative breast cancer that is no longer responding to aromatase inhibitors (anti-estrogen therapies).
The purpose of this study is to compare the effects of using Z-Endoxifen HCL to using tamoxifen. Z-Endoxifen HCL could shrink cancer and prevent it from spreading, but it could also cause side effects. This study will allow the researchers to know whether this new approach is better, the same, or worse than the usual approach of using tamoxifen.
Patients will be followed for a maximum of 5 years after registration into the study.
*An additional core needle biopsy of the breast cancer tissue or site of metastatic disease is required.