BREAST: METASTATIC: TNBC: 1st Line: CONTESSA TRIO

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

Title
ODONATE ODO-TE-B301 (CONTESSA TRIO)
Study Title

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

Site Link
Malignancy
Breast cancer, triple-negative breast cancer, TNBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Tesetaxel, nivolumab, pembrolizumab, atezolizumab
Drug Class
oral taxane, PD-1 or PD-L1 inhibitors
PI
Lee Schwartzberg, MD
Sponsor
Odonate Therapeutics, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • ER -, PR-, HER2 - biopsy proven breast cancer
  • Locally advanced (not curable by surgery or radiation) or metastatic
  • No prior chemotherapy for metastatic disease
  • (Neo)Adjuvant therapy allowed if disease free interval of at least 12 months after completion
  • No prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors
  • Tissue available for PD-1 level determination
  • ECOG PS 0-2
  • No known HIV/HBV/HCV
  • No history of active autoimmune disease
  • No Grade 2 or higher neuropathy
Objective
  • Primary- ORR, PFS
  • Secondary- DoR, OS
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
ER negative, PR negative, HER2 negative
Dosing Frequency
Control Agents
Study Protocol
<p>S:\\Research\\Protocols\\Odonate ODO-TE-B301 (OTE 12.18.17)\\Protocol\\Current Protocol</p>
Randomized
No
X