This trial is examining the effectiveness of tesetaxel plus a reduced dose of capecitabine for hormone receptor (HR) positive/HER2 negative advanced breast cancer. The main outcome to be measured will be progression free survival (time from treatment until disease progression).
Breast cancer is classified into different subtypes depending on the presence or absence of certain receptors (proteins found on the surface of the cancer cells). These subtypes influence treatment options, and also directly affect disease prognosis. Hormone receptor positive cancer grows in response to female hormones such as estrogen. Tesetaxel and capecitabine are chemotherapy drugs. They work by damaging the rapidly dividing cancer cells.
This study will examine whether tesetaxel is an effective treatment for advanced hormone positive breast cancer. The main outcome will be measured as time to disease progression.
Who are they looking for?
This study is recruiting 600 participants who have had at least one dose of taxane-based and an anthracycline-based chemotherapy. Participants must have adequate blood, liver, and kidney function. Patients must not be pregnant, and both males and females must use contraception throughout the trial.
Patients should not have had two or more prior chemotherapy regimens for advanced disease. Patients should not have liver, renal, neurological or bleeding disorders. Patients should not have uncontrolled HIV, hepatitis, or any psychiatric disorders.
How will it work
Participants will be randomly assigned to one of two groups. One will receive tesetaxel every 21 days plus a reduced dose of capecitabine twice daily for 15 days of the 21-day cycle. The other group will receive a full dose of capecitabine twice a day for 15 days of a 21-day cycle. Treatment will end when the cancer progresses, or when there are unacceptable side-effects.
Participants will be followed for up to 5.5 years.