Post Menopausal, Hormone Receptor Positive Breast Cancer Clinical Trial
Official title:
A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer
In this study the investigators want to find out about the effects of this drug in women with
metastatic breast cancer. The study has two major parts; dose escalation and dose expansion.
In the first part or dose escalation, subjects will be treated at the lowest dose effective
in men: 300 mg two times daily. Orteronel (TAK-700) will be increased to reach the highest
dose tolerated in men: 400 mg two times daily. This part of the study is designed to see if
female subjects can safely tolerate orteronel (TAK-700), and to measure the changes in
estrogens and androgens at different levels of TAK-700.
In the second part of the study (dose expansion), seven women will be treated with the dose
identified in the first part of the study as being safest and most effective. In this part of
the study, the investigators want to see if orteronel (TAK-700) will routinely and
significantly decrease the estrogen levels at the dose which will be used for any future
studies.
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