A Phase III Study of Capecitabine with or without Tesetaxel for HER2-Negative Breast Cancer

Full Title

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

Purpose

The purpose of this study is to learn how well the combination of tesetaxel and a reduced dose of another anticancer drug called capecitabine works, compared with the standard higher dose of capecitabine given alone, in patients with locally advanced or metastatic HER2-negative breast cancer.

Tesetaxel is an oral taxane (the same class of drugs as paclitaxel, a commonly used intravenous breast cancer drug). Capecitabine is also taken orally. In this study, patients will be randomly assigned to receive tesetaxel plus a lower dose of capecitabine, or the standard dose of capecitabine alone.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced or metastatic HER2-negative breast cancer that has continued to grow despite therapy.
  • Patients may not have previously received capecitabine, nor a taxane drug for metastatic disease.
  • At least 2 weeks must pass between the completion of prior treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Andrew Seidman at 646-888-4559.

Protocol

18-172

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases