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This study will investigate the use of tesetaxel in patients with taxane-naïve, HER2-, HR+ locally advanced or metastatic breast cancer.
Who is it for?
You may be eligible for this study if you meet the below criteria:
Participants will receive tesetaxel at 27 mg/m2 orally once every 21 days on the first day of each 21-day cycle plus capecitabine at 825 mg/m2 orally twice daily (for a total daily dose of 1,650 mg/m2) for 14 days of each 21-day cycle. Patients in the dense pharmacokinetics (PK) cohort will also receive a single dose of capecitabine monotherapy prior to starting the combination regimen. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in locally advanced/metastatic breast cancer. The primary endpoint is objective response rate as assessed by an IRC. The secondary efficacy endpoints are duration of response as assessed by the independent radiologic review committee, progression-free survival as assessed by the independent r adiologic review committee, disease control rate as assessed by the independent radiologic review committee and overall survival. CONTESSA 2 will also investigate the pharmacokinetics of tesetaxel.
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