A Phase II Study of Tesetaxel in Combination with Capecitabine in People with Breast Cancer

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Full Title

A Multinational, Multicenter, 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

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the investigational drug tesetaxel with a lower dose of the chemotherapy drug capecitabine in patients with locally advanced or metastatic breast cancer that is negative for the HER2 protein and positive for hormone receptors. Researchers think these two drugs may be more effective if given together rather than on their own.

Tesetaxel belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Taxanes block cancer growth by stopping cells from dividing. Patients in this study may not have previously received a taxane (such as paclitaxel or docetaxel). Both tesetaxel and capecitabine are taken orally (by mouth).

Eligibility

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

  • Patients must have HER2-negative hormone receptor-positive locally advanced or metastatic breast cancer.
  • Patients may not have previously received a taxane drug or capecitabine, nor more than one prior regimen of chemotherapy for advanced cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women and men ages 18 and older.

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

Protocol

20-152

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

Brockway-Marchello, Julia, MD