Odonate Therapeutics has started a new Phase lll trial of tesetaxel in patients with locally advanced or metastatic breast cancer (MBC).

The multinational, multicentre, randomised trial is named CONTESSA and will enrol around 600 patients.

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It will see a comparison of tesetaxel dosed orally at 27mg/m² on the first day of a 21-day cycle, plus a reduced dose of oral chemotherapy agent capecitabine to the approved dosage of capecitabine alone in enrolled patients.

Patients will be randomised 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.

CONTESSA’s primary endpoint is progression-free survival (PFS) to be assessed by an independent radiologic review committee (IRC).

“Despite recent advances in the treatment of advanced breast cancer, there remains a significant need for new therapies that allow patients to maintain a better quality of life.”

The trial’s secondary efficacy endpoints will include overall survival, objective response rate (ORR) assessed by IRC, disease control rate (ORR + prolonged (≥ 24 weeks) stable disease) evaluated by IRC and patient-reported outcomes.

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Odonate Therapeutics chairman and CEO Kevin Tang said: “Despite recent advances in the treatment of advanced breast cancer, there remains a significant need for new therapies that allow patients to maintain a better quality of life.

“CONTESSA is designed to evaluate the potential benefit of an all-oral regimen that combines tesetaxel with a reduced dose of capecitabine as compared to the approved dose of capecitabine alone, with the goal of establishing a new, all-oral treatment option with an improved benefit-risk profile.”

Tesetaxel is currently under development by Odonate, and is an investigational, orally administered chemotherapy agent that belongs to taxanes class of drugs commonly used to treat cancer.

So far, more than 500 patients have been treated with tesetaxel across 22 different clinical trials.