Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC

Official Title

A Multinational, Multicentre, 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

Summary:

CONTESSA is a multinational, multicentre, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study 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). Approximately 600 patients will be enrolled.

Trial Description

Primary Outcome:

  • PFS
Secondary Outcome:
  • OS
  • ORR
  • DCR
  • CNS ORR in patients with CNS metastases at baseline
  • CNS PFS in patients with CNS metastases at baseline or a history of CNS metastases in the intent-to-treat (ITT) population
  • CNS OS in patients with CNS metastases at baseline or a history of CNS metastases
CONTESSA is a multinational, multicentre, randomized, Phase 3 study of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive locally advanced or metastatic breast cancer (LA/MBC) previously treated with a taxane in the neoadjuvant or adjuvant setting. Approximately 600 patients will be enrolled. 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. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. The primary endpoint is PFS as assessed by an IRC. The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by an IRC, and disease control rate (DCR) as assessed by an IRC.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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