An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)

Merck Sharp & Dohme LLC866 enrolled

Overview

This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

866

Conditions

Nausea Vomiting Breast Neoplasms

Interventions

MK0869, aprepitant / Duration of Treatment: 3 daysDRUG

Comparator: ondansetron / Duration of Treatment: 3 daysDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy. Exclusion Criteria: * Patient has a central nervous system malignancy. * Patient will receive radiation to the abdomen or pelvis.

Outcomes

Primary Outcomes

Emesis and use of rescue medication

Safety and tolerability

Secondary Outcomes

Quality of life

Data from ClinicalTrials.gov

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