Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC

Official Title

Multinational, Multicentre, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

Summary:

CONTESSA 2 is a multinational, multicentre, Phase 2 study of tesetaxel in patients with taxane-naïve, HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC). The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine, based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). Approximately 125 patients will be enrolled.

Trial Description

Primary Outcome:

  • ORR
Secondary Outcome:
  • DoR
  • PFS
  • DCR
  • OS
  • CNS ORR in patients with CNS metastases at baseline
  • CNS DoR in patients with CNS metastases at baseline
  • CNS PFS in patients with CNS metastases at baseline or a history of CNS metastases and in the intent-to-treat (ITT) population
  • CNS OS in patients with CNS metastases at baseline or a history of CNS metastases
CONTESSA 2 is a multinational, multicentre, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with HER2 negative, HR Positive, LA/MBC not previously treated with a taxane in the neoadjuvant, adjuvant or metastatic setting. This Study complements CONTESSA, a multinational, multicentre, randomized, Phase 3 study in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. In CONTESSA 2, approximately 125 patients will be enrolled to 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 LA/MBC. The primary endpoint is ORR as assessed by an IRC. The secondary efficacy endpoints are duration of response as assessed by the IRC, progression-free survival as assessed by the IRC, disease control rate as assessed by the IRC and overall survival. CONTESSA 2 will also investigate the PK of tesetaxel.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society