BREAST: METASTATIC: ER/PR+: HER2 neg: No prior taxane: CONTESSA 2

Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

Title
Odonate ODO-TE-B201 (CONTESSA 2)
Study Title

Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

Site Link
Malignancy
Breast cancer, invasive breast cancer, BC, hormone receptor positive BC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st line chemo (most likely)
Investigational Agent
tesetaxel
Drug Class
oral taxane
PI
Lee Schwartzberg, MD
Sponsor
Odonate Therapeutics, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Pathologically confirmed locally advanced unresectable or metastatic breast cancer
  • HER2 negative (-) disease
  • Hormone receptor (ER and/or PR) positive (+)
  • Measurable disease
  • CNS disease is allowed provided that patient is neurologically stable on maximum dose of 4mg dexamethosone, no leptomeningeal disease, and no local-directed CNS treatmnt is immediately necessary
  • ECOG PS 0-2
  • No limit on number of prior endocrine therapies
  • No more than 2 prior lines of chemotherapy
  • No prior treatment with either capecitabine or any taxane
  • No other malignancies within 5 years except with discussion with medical monitor
  • No HIV, HBV, HCV
  • No Grade 2 or higher neuropathy
  •  
Objective
  • Primary- ORR
  • Secondary- DoR, PFS, DCR, OS, CNS efficacy
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
ER/PR positive, HER2 negative
Dosing Frequency
Control Agents
Study Protocol
<p>S:\\Research\\Protocols\\Odonate ODO-TE-B201\\Protocol</p>
Randomized
No
X