West Cancer Center

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

Site Link

NCT03858972

Malignancy

Breast cancer, invasive breast cancer, BC, hormone receptor positive BC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st line chemo (most likely)

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

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

Assessment Frequency Link

Path

ER/PR positive, HER2 negative

Dosing Frequency

Control Agents

Study Protocol

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Randomized