SHS_492407 ELLE CODO 18001

Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane

Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, MBC (CONTESSA)

Inclusion Criteria:

• HER2 negative disease based on local testing
• HR (ER and/or PgR) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status.
• Measurable disease per RECIST 1.1 or bone-only disease with lytic component.
• Prior therapy with a taxane-containing regimen in the neoadjuvant or adjuvant setting
• Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated
• Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
• Documented disease recurrence or disease progression
• Adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

• Two or more prior chemotherapy regimens for advanced disease
• Prior treatment with a taxane in the metastatic setting
• Prior treatment with capecitabine
• Known metastases to the central nervous system
• Other cancer that required therapy within the preceding 5 years other than adequately treated non-melanoma skin cancer or in situ cancer
• Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
• Active hepatitis B or active hepatitis C infection
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study.
• Presence of neuropathy > Grade 1 per NCI CTCAE version 4.03
• History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this Study
• Anticancer treatment, including endocrine therapy, radiotherapy, chemotherapy, or biologic therapy, ≤ 14 days prior to the date of Randomization
• Major surgery ≤ 28 days prior to the date of Randomization; patient must have complete recovery from surgery
• 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 cytochrome P450 (CYP)3A or CYP2C9 pathways (patients should discontinue taking any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A or CYP2C9 pathways)
• History of hypersensitivity to capecitabine, other fluoropyrimidine agents, or any of their ingredients
• Known dihydropyrimidine dehydrogenase (DPD) deficiency
• Pregnant or breastfeeding
Phase III
Erin Ellis, M.D.
Odonate Therapetics, LLC
Casey Daniels
  • Swedish Medical Center