BREAST: METASTATIC: HER2 negative: 1st Line: Older Adults: CONTESSA TRIO >65

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 OLDER ADULTS)
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, Metastatic Breast Cancer, MBC,
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line Chemo
Investigational Agent
Tesetaxel
Drug Class
Oral taxane
PI
Lee Schwartzberg, MD
Sponsor
Odonate Therapeutics, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Age 65 or older
  • Locally advanced breast cancer not considered curable by surgery or radioation or metastatic breast cancer
  • Measurable Disease
  • Brain mets are allowed
  • ECOG PS 0-2
  • If ER/PR+, must have received prior therapy with endocrine therapy (+/- CDK 4/6 therapy).
  • Any number of prior endocrine or targeted therapies are permitted
  • No prior chemotherapy for metastatic disease
  • No known HIV/HBV/HCV
  • No Grade >1 neuropathy
Objective
  • Primary- ORR
  • Secondary- PFS, DoR, OS
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
HER2 negative (Any ER or PR status)
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