West Cancer Center

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

NCT03952325

Malignancy

Breast, Metastatic Breast Cancer, MBC,

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line Chemo

Investigational Agent

Tesetaxel

Drug Class

Oral taxane

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Phase

Phase 2

Status

Closed to Accrual

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

Assessment Frequency Link

Path

HER2 negative (Any ER or PR status)

Dosing Frequency

Control Agents

Study Protocol

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Randomized