Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer

Key inclusion criteria:

Female
At least 18 years of age
Locally advanced non-resectable or metastatic breast cancer
HER2 negative disease
Measurable disease per revised RECIST, Version 1.1
Eastern Cooperative Oncology Group performance status 0 or 1
Chemotherapy naïve, OR 1 prior chemotherapy regimen in the neoadjuvant or adjuvant setting provided the patient has had a disease-free interval of ≥ 12 months after ending this chemotherapy. If the neoadjuvant or adjuvant chemotherapy included a taxane, ≥ 2 years must have passed since this treatment ended.
Documented disease recurrence or progression
Adequate bone marrow, hepatic, and renal function
Ability to swallow an oral solid-dosage form of medication
Written informed consent

Key exclusion criteria:

Known metastasis to the central nervous system
Other cancer within the preceding 5 years other than curatively treated basal or squamous cell carcinoma of the skin or carcinoma of the cervix in situ
Significant medical disease other than breast cancer
Presence of neuropathy > Grade 1 (NCI CTC)
History of hypersensitivity to a taxane or capecitabine, other fluoropyrimidine agents, or any of their ingredients
History of severe or unexpected reaction to fluoropyrimidine therapy
Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway
Known dihydropyrimidine dehydrogenase deficiency
Pregnancy or lactation