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Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer

NCT03367572 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1363

Last updated 2025-09-25

Study results available
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Summary

This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.

Conditions

  • Breast Carcinoma

Interventions

DRUG

Dexamethasone

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Netupitant/Palonosetron Hydrochloride

Given PO

DRUG

Olanzapine

Given PO

OTHER

Placebo

Given PO

DRUG

Prochlorperazine

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Rochester NCORP Research Base

    lead OTHER

Principal Investigators

  • Luke Peppone · University of Rochester NCORP Research Base

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2024-04-13
Completion
2024-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03367572 on ClinicalTrials.gov