BREAST: Metastatic: HR Positive: HER2 Negative: 1st or 2nd line: "CONTESSA"

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

Title
Odonate ODO-TE-B301 (CONTESSA BREAST)
Study Title

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

Site Link
Malignancy
Breast, Breast Cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st or 2nd Line Chemotherapy after receipt of adjuvant/neoadjuvant taxane. Any number of prior endocrine tx allowed.
Investigational Agent
Tesetaxel
Drug Class
Orally administered taxane
PI
Lee Schwartzberg, MD
Sponsor
Odonate Therapeutics
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • HER2 negative disease
  • HR (ER and/or PgR) psoitive disease
  • Measurable disease
  • ECOG PS 0-2
  • Must have received prior taxane containing regimen in the neoadjuvant or adjuvant setting
  • If indicated, must have received prior anthracycline containing regimen in neoadjuvant, adjuvant, or metastatic setting
  • Unless not indicated (e.g. rapidly progressing disease), must have received prior endocrine therapy. No limit on number of prior endocrine therapies or targeted therapies (CDK4/6, everolimus)
  • Documented disease recurrence or progression
  • Ability to swallow pills
  • No more than 1 prior chemotherapy regimen for advanced disease (not including targeted therapy)
  • No prior use of a taxane in the metastatic setting
  • No known CNS involvement
  • No other cancer within 5 years
  • No known HIV/HBV/HCV
  • No neuropathy > Grade 1
Objective

Primary- PFS: Secondary- OS, ORR, DCR: Other- Patient Reported Outcomes; Safety

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Hormone Receptor Positive, ER Positive, PR positive, HER2 Negative, HER2-
Dosing Frequency
Control Agents
capecitabine 1250mg
Study Protocol
Randomized
Yes
X