NCT00092183

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
866

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2004

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

September 21, 2004

Last Update Submit

May 2, 2017

Conditions

NauseaVomitingBreast Neoplasms

Keywords

Chemotherapy-Induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

  • Emesis and use of rescue medication

  • Safety and tolerability

Secondary Outcomes (1)

  • Quality of life

Interventions

MK0869, aprepitant / Duration of Treatment: 3 daysDRUG
Comparator: ondansetron / Duration of Treatment: 3 daysDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.

You may not qualify if:

  • Patient has a central nervous system malignancy.
  • Patient will receive radiation to the abdomen or pelvis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30. doi: 10.1200/JCO.2005.09.050.

    PMID: 15837996BACKGROUND

MeSH Terms

Conditions

NauseaVomitingBreast Neoplasms

Interventions

AprepitantDuration of Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2004

First Posted

September 24, 2004

Study Start

October 10, 2002

Primary Completion

December 1, 2003

Study Completion

February 11, 2004

Last Updated

May 5, 2017

Record last verified: 2017-05