Breast Cancer Clinical Trial
Official title:
Phase 1 Study of Mifepristone in Combination With Eribulin in Patients With Locally Advanced/Metastatic Breast or Other Specified Solid Tumors, With a Dose Expansion Cohort in Patients With Triple Negative Breast Cancer.
This is a study to assess the safety of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable breast or other specified solid tumors, and determine preliminary efficacy of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable Triple Negative Breast Cancer (TNBC). The structure for the study is a single arm, non-randomized, open-label, multicenter trial with no control group. The study will be conducted at up to 11 sites, with up to 40 evaluable patients
There will be two parts to the study: Part 1, a dose escalation phase, in which the MTD and
RP2D will be determined in up to 20 patients with metastatic breast or other specified solid
tumors, regardless of receptor status; and Part 2, a dose expansion phase in which a
preliminary estimate of efficacy will be made in an expansion group of up to 20 patients with
glucocorticoid receptor-positive metastatic TNBC at the RP2D.
Treatment will be administered in 21-day cycles, with the exception of the first cycle, which
will be of 28 days duration with a lead-in of 7 days dosing of mifepristone.
Cycle 1 (28-day cycle): Mifepristone administered orally (PO) with food once daily for 28
days. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on days 8 and 15.
Cycle 2 and beyond (21-day cycle): Mifepristone administered orally (PO) with food once daily
for 21 days. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on days 1
and 8.
Enrollment in Part 2 of the study (dose expansion) will occur once the RP2D has been
determined. Patients in the dose expansion study must have TNBC disease that is
glucocorticoid receptor-positive (by immunohistochemistry [IHC]). Patients will be treated in
repeated 21-day cycles until progression or another withdrawal criterion is met.
Part 1 of the study is complete. Part 2 of the study is ongoing.
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