West Cancer Center

BREAST: EARLY STAGE: SUPPORTIVE CARE: RECEIVING AC: NEPA 17-05

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo®) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

Title

Helsinn NEPA 170-05 (Breast Cancer-Supportive Care)

Study Title

Site Link

NCT03403712

Malignancy

Breast, Breast Cancer, TNBC, ER+ breast cancer

Stage

Stage 2

Disease Setting

Prior to AC therapy, regardless of stage

Line Of Therapy

Investigational Agent

fosnetupitant/palnosetron (IV) or netupitant/palonosetron (oral)

Drug Class

NK1 receptor antagonist, anti-emetic

Lee Schwartzberg, MD

Sponsor

Helsinn Healthcare SA

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically or cytologically confirmed breast cancer, including recurrent or metastatic
Naive to moderately or highly emetogenic antineoplastic agents
Scheduled to receive at least 4 consecutive cycles of an AC combination regimen
ECOG PS 0-1
Not scheduled to receive other moderately or highly emetogenic agent (other than AC) from 6 hours after starting AC until next cycle
No CNS involvement
No concurrent investigational agent/study

Objective

Primary- treatment-emergent AEs at Cycle 1, 2, 3, 4. Secondary- emetic episodes; rescue therapy, severity of nausea, FLIE questionnaire

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes