Facilitated By

San Antonio Medical Foundation

A Multinational, Multicenter, Randomized, Phase 3 Study Of Tesetaxel Plus A Reduced Dose Of Capecitabine Versus Capecitabine Alone In Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced Or Metastatic Breast Cancer Previously Treated With A Taxane

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
HJF
Research Start Date
Status
Active

This is a multinational, multicenter, randomized, open-label, parallel-group Phase 3 study. The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (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. Approximately 600 eligible patients will be randomly assigned in a 1:1 ratio to either Arm A (tesetaxel plus a reduced dose of capecitabine) or Arm B (approved dose of capecitabine alone). Prior to Randomization, patients will be stratified according to: Disease status (presence versus absence of visceral disease), Geographic region (North America/Western Europe versus Rest of World), Number of prior chemotherapy regimens for advanced disease (0 versus 1) . 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. Patients will be followed for up to 60 months from the date of Randomization, unless death, lost to follow-up, or Study closure. Tumor response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Radiologic response and progression will be assessed by the Investigator and separately assessed for the primary analysis by the IRC. Details of the independent review will be provided in a separate IRC charter. Patient-reported outcomes of health-related quality of life (QoL), functional scales, and symptom scales/items will be collected. Sparse PK sampling will be conducted for patients at select Study sites.

Collaborative Project
Clinical Care
Cancer
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