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Tak700 (orteronel) dose escalation schedule:

* 1a 200 mg PO BID TAK700
* 1b 200mg PO BID TAK + glucocorticoid

  1a 300mg PO BID TAK700 starting dose

  1b 300 mg po BID + glucocorticoid 2a 400mg PO BID TAK700 2b 400 mg po BID + glucocorticoid

dose is dependant on dose escalation timepoint and dose expansion cohort dose will be the RP2D determined based on the dose escalation cohort final dose recommendation

TAK700

Amye J Tevaarwerk, MD

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.

A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer

Assess changes in serum estrogen, progesterone, androgen and other hormones in response to orteronel, and correlate tumor response to orteronel with reduction in serum levels of estrogens and androgens. See Table 4-1 and 4-2 for planned steroid hormone and other endocrine levels.

Correlate response to orteronel with tumor expression of androgen receptor (AR), estrogen receptor alpha (ERα), and progesterone receptor (PgR), determined by immunohistochemistry (IHC) in primary and/or metastatic biopsies.

Determine the RP2D of orteronel in postmenopausal women with hormone-receptor positive (HR+) metastatic breast cancer.

To demonstrate clinically significant decrease in serum estradiol following treatment with orteronel at RP2D in postmenopausal women with HR+ metastatic breast cancer.

Determine the overall response rate (ORR) and disease control rate (DCR) for orteronel in all patients treated with orteronel on protocol

Determine toxicity of orteronel in patients being treated at the RP2D

Demonstrate the pharmacodynamic activity of orteronel by assessing steroid hormone and other endocrine levels before and following administration of orteronel.

To determine the ORR, DCR, progression-free survival (PFS) and time-to-progression (TTP) in HR+ metastatic breast cancer patients receiving orteronel in the dose-expansion cohort

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer	NCT01808040	Post Menopausal...	TAK700	18 Years -	University of Wisconsin, Madison
A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer	NCT01808040	Post Menopausal...	TAK700	18 Years -	University of Wisconsin, Madison
A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer	NCT01808040	Post Menopausal...	TAK700	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for post menopausal, hormone receptor positive breast cancer