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Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
Odonate Therapeutics, LLC
The primary objective of this trial is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on PFS, as assessed by an Independent Radiologic Review Committee (IRC), in patients with HER2 negative, HR positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
Patients randomly assigned to Arm A (tesetaxel plus a reduced dose of capecitabine) will be administered:
•Tesetaxel (27 mg/m2) orally once every 21 days on Day 1 of each 21-day cycle; and
•Capecitabine (825 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Patients randomly assigned to Arm B (approved dose of capecitabine alone) will be administered:
• Capecitabine (1,250 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2), beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle Dose modifications for tesetaxel and/or capecitabine are described in the Study protocol.
Patients will be treated until documentation of progressive disease (PD), evidence of unacceptable toxicity, or other decision to discontinue treatment.