Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients
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ClinicalTrials.gov Identifier: NCT00869973 |
Recruitment Status
:
Terminated
(We terminated the study after enrolling 580/900 patients due to a slow accrual)
First Posted
: March 26, 2009
Last Update Posted
: January 23, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Emesis | Drug: Aprepitant Drug: dexamethasone | Phase 3 |
This is a phase III, double-blind, randomized trial, to evaluated the efficacy and safety of aprepitant for the prevention of delayed emesis in patients with breast cancer submitted for the first time to chemotherapy with cyclophosphamide plus anthracyclines.
The study will be carried out during the first cycle of chemotherapy.
For the prevention of acute emesis, all patients will receive, before chemotherapy:
- dexamethasone 8 mg iv in 15 minutes, 30 minutes before chemotherapy;
- palonosetron 0.25 mg iv bolus, 30 minutes before chemotherapy
- aprepitant 125 mg orally, 60 minutes before chemotherapy
After 24 hours from chemotherapy administration, patients will be randomized to receive:
A) 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.
B) Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3.
The patients will receive prochlorperazine suppositories as rescue medication, for important nausea and vomiting (> 2 episodes) during days 1-5 after chemotherapy.
The patients will receive a diary, which includes a Visual Analogue Scale (VAS) for nausea and vomiting evaluation. All patients will fill out the diary in which, for 6 consecutive days (days 1-6), patients will report for each day the number of vomiting episodes, the intensity and duration of nausea, any antiemetic rescue medication and any adverse event and its treatment.
In addition, on day 1 before chemotherapy and then on day 6, patients will fill out the FLIE (Functional Living Index-Emesis), a questionnaire concerning the impact of nausea and vomiting on their quality of life.
Primary end point is the percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 580 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Aprepitant in the Prevention of Delayed Emesis Induced by Moderately Emetogenic Chemotherapy (Cyclophosphamide Plus Anthracyclines) in Breast Cancer Patients: a Double-blind Randomized Study |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Aprepitant
|
Drug: Aprepitant
Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3
|
Active Comparator: 2
dexamethasone
|
Drug: dexamethasone
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
|
- Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration [ Time Frame: 6 days ]
- Evaluation of the impact on quality of life of the two antiemetic regimens [ Time Frame: 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 [ Time Frame: 6 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869973
Italy | |
Fausto Roila | |
Terni, Italy, 05100 |
Principal Investigator: | Fausto Roila, MD | Oncology Division, S. Maria Hospital, Terni, Italy |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Roila Fausto, Dr, S. Maria Hospital, Terni |
ClinicalTrials.gov Identifier: | NCT00869973 History of Changes |
Other Study ID Numbers: |
IGAR-02-2009 2008-001237-95 |
First Posted: | March 26, 2009 Key Record Dates |
Last Update Posted: | January 23, 2013 |
Last Verified: | October 2009 |
Keywords provided by Roila Fausto, S. Maria Hospital, Terni:
aprepitant delayed emesis cyclophosphamide plus anthracyclines breast cancer antiemetic |
Additional relevant MeSH terms:
Breast Neoplasms Vomiting Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone acetate Dexamethasone Aprepitant Fosaprepitant Cyclophosphamide BB 1101 Anti-Inflammatory Agents |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors |