This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Patients should take zunsemetinib at approximately the same times every day, with or without food with 8 oz of water.
Patients should take capecitabine at approximately the same times every day, within 30 minutes after a meal.
Standard of care. Will receive zoledronic acid or denosumab.
The University of Kansas Cancer Center
Westwood, Kansas, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
NOT_YET_RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGNumber of participants with adverse events (Phase Ib only)
Time frame: From start of treatment through 30 days after end of treatment (estimated to be 11 months)
Recommended phase II dose of zunsemetinib (Phase Ib only)
Time frame: Through end of 1st cycle (each cycle is 21 days)
Number of participants with dose-limiting toxicities (Phase Ib only)
Time frame: Through end of 1st cycle (each cycle is 21 days)
Percent change in serum CTX (Phase II only)
Time frame: Baseline and Day 1 of week 7
Progression-free survival (PFS) (Phase II only)
Time frame: From start of treatment through completion of follow-up (estimated to be 3 years and 10 months)
Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only)
Time frame: Baseline, end of cycle 8 (each cycle is 21 days), and end of treatment (estimated to be 10 months)
Treatment-induced changes in sCTX by clinical assay (Phase II only)
Time frame: Baseline, cycle 1 day 1 pre-dose, cycle 1 day 8 pre-dose, cycle 1 day 15 pre-dose, day 1 of subsequent cycles (each cycle is 21 days), and end of treatment (estimated to be 10 months)
Objective response rate (ORR) (Phase II only)
Time frame: Through completion of treatment (estimated to be 10 months)
Clinical benefit rate (Phase II only)
Time frame: Through completion of treatment (estimated to be 10 months)
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Standard of care. Will receive zoledronic acid or denosumab.
Overall survival (OS) (Phase II only)
Time frame: From start of treatment through completion of follow-up (estimated to be 3 years and 10 months)
Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only)
Time frame: Baseline, end of cycle 8, and end of treatment (estimated to be 10 months)
Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only)
Time frame: Prior to start of 1st treatment, cycle 5 day 1, every 4 cycles thereafter (each cycle is 21 days), and at the time of progression (estimated to be 3 years and 10 months)
Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only)
Time frame: Prior to start of 1st treatment, cycle 5 day 1, every 4 cycles thereafter (each cycle is 21 days), and at the time of progression (estimated to be 3 years and 10 months)
Number of participants with adverse events (Phase II only)
Time frame: From start of treatment through 30 days after end of treatment (estimated to be 11 months)