West Cancer Center

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-B202 (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

NCT03952325

Malignancy

Breast cancer, triple-negative breast cancer, TNBC

Stage

Stage 4

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

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Phase

Phase 2

Status

Closed to Accrual

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

Assessment Frequency Link

Path

ER negative, PR negative, HER2 negative

Dosing Frequency

Control Agents

Study Protocol

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Randomized