Tesetaxel as First-line Therapy for Metastatic Breast Cancer

Primary Inclusion Criteria:

Female
At least 18 years of age
Histologically or cytologically confirmed adenocarcinoma of the breast
Stage IV disease
HER2 status negative
Measurable disease (revised RECIST; Version 1.1)
Eastern Cooperative Oncology Group performance status 0 or 1
Life expectancy of at least 3 months
Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
Prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated
Adequate bone marrow, hepatic, and renal function, as specified in the protocol
At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
Ability to swallow an oral solid-dosage form of medication

Primary Exclusion Criteria:

Known metastasis to the central nervous system
History of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ
Significant medical disease other than Stage IV breast cancer
Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
History of hypersensitivity to a taxane
Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity