NCT00869973

Brief Summary

The aim of the study is to compare efficacy and tolerability of aprepitant versus dexamethasone in the prevention of delayed emesis induced by moderately emetogenic chemotherapy (cyclophosphamide plus anthracyclines) in breast cancer patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
580

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 23, 2013

Status Verified

October 1, 2009

Enrollment Period

2.8 years

First QC Date

March 25, 2009

Last Update Submit

January 22, 2013

Conditions

Emesis

Keywords

aprepitantdelayed emesiscyclophosphamide plus anthracyclinesbreast cancerantiemetic

Outcome Measures

Primary Outcomes (1)

  • Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration

    6 days

Secondary Outcomes (2)

  • Evaluation of the impact on quality of life of the two antiemetic regimens

    6 days

  • Evaluation of the prognostic factors of delayed emesis in patients receiving a combination of aprepitant, palonosetron and dexamethasone for the prevention of acute emesis

    6 days

Study Arms (2)

1

EXPERIMENTAL

Aprepitant

Drug: Aprepitant

2

ACTIVE COMPARATOR

dexamethasone

Drug: dexamethasone

Interventions

AprepitantDRUG

Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3

1
dexamethasoneDRUG

dexamethasone 4 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on day 3

2

Eligibility Criteria

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

You may qualify if:

  • patients with breast cancer, receiving for the first time chemotherapy with cyclophosphamide + anthracyclines (FAC, FEC, AC, EC).
  • patients over 18 years old and those who signed informed consent
  • adequate contraception if premenopausal women
  • Every other anticancer drug in the first 24 hours will be administered after the end of cyclophosphamide plus anthracycline.

You may not qualify if:

  • patients already submitted to chemotherapy
  • patients receiving any chemotherapy on days 2-4 after treatment
  • patients with concomitant severe diseases or with predisposition to emesis such as intestinal obstruction, active peptic ulcer, hypercalcemia and brain metastases
  • contraindications to corticosteroids (i.e., active peptic ulcer or previous bleeding from peptic ulcer
  • patients submitted to concomitant radiotherapy or submitted to radiotherapy in the 15 days before chemotherapy or planned to receive radiotherapy during the 8 days after chemotherapy
  • patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy
  • patients with nausea or vomiting in the 24 hours before chemotherapy
  • patients receiving concomitant steroids, except when administered at physiologic doses
  • patients receiving concomitant benzodiazepines, except when used for nocturnal sedation
  • patients with WBC count \<3000/mm3 or platelet count \<70000/mm3
  • patients who are pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fausto Roila

Terni, Terni, 05100, Italy

Location

Related Publications (7)

  • 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: 15837996RESULT

  • Roila F, Hesketh PJ, Herrstedt J; Antiemetic Subcommitte of the Multinational Association of Supportive Care in Cancer. Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol. 2006 Jan;17(1):20-8. doi: 10.1093/annonc/mdj078. Epub 2005 Nov 28.

    PMID: 16314401RESULT

  • Eisenberg P, Figueroa-Vadillo J, Zamora R, Charu V, Hajdenberg J, Cartmell A, Macciocchi A, Grunberg S; 99-04 Palonosetron Study Group. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron. Cancer. 2003 Dec 1;98(11):2473-82. doi: 10.1002/cncr.11817.

    PMID: 14635083RESULT

  • Gralla R, Lichinitser M, Van Der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, Labianca R, Macciocchi A, Aapro M. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003 Oct;14(10):1570-7. doi: 10.1093/annonc/mdg417.

    PMID: 14504060RESULT

  • Italian Group For Antiemetic Research. Randomized, double-blind, dose-finding study of dexamethasone in preventing acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide: J Clin Oncol. 2004 Feb 15;22(4):725-9. doi: 10.1200/JCO.2004.09.040.

    PMID: 14966097RESULT

  • Italian Group for Antiemetic Research. Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med. 2000 May 25;342(21):1554-9. doi: 10.1056/NEJM200005253422102.

    PMID: 10824073RESULT

  • Roila F, Ruggeri B, Ballatori E, Del Favero A, Tonato M. Aprepitant versus dexamethasone for preventing chemotherapy-induced delayed emesis in patients with breast cancer: a randomized double-blind study. J Clin Oncol. 2014 Jan 10;32(2):101-6. doi: 10.1200/JCO.2013.51.4547. Epub 2013 Dec 9.

    PMID: 24323030DERIVED

MeSH Terms

Conditions

VomitingBreast Neoplasms

Interventions

AprepitantDexamethasone

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 CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Fausto Roila, MD

    Oncology Division, S. Maria Hospital, Terni, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 23, 2013

Record last verified: 2009-10

Locations

IT(1)