Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.

Exclusion Criteria

• •1. Patient is scheduled to receive any chemotherapy treatment different to the Docetaxel-Cyclophosphamide chemotherapy.
• •2. Patient has received or will receive radiation therapy to the abdomen, chest or pelvis in the month prior to the study enter.
• •3. Patient has vomited in the 24 hours prior to Treatment Day 1.
• •4. Patient has a history of treatment with emetogenic chemotherapy of moderate or high level per "Hesketh" (classification of emetogenic chemotherapy agents).
• •5. Patient has an active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
• •6. Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
• •7. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
• •8. Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
• •9. Patient has a history of hypersensitivity to aprepitant, 5-HT3 antagonists, or dexamethasone.
• •10. Patient is pregnant or breast feeding.
• •11. Patient has participated in a study with aprepitant or has taken a non approved (investigational) drug within the last 4 weeks.
• •12. Patient is taking systemic corticosteroid therapy at any dose; topical and inhaled corticosteroids are permitted.
• •13. Patient is taking, or will be taking within 28 days of Day 1 of cycle 2 (cycle in which patients will start taking aprepitant) the following CYP3A4 inducers:
• •* phenytoin or carbamazepine
• •* barbiturates
• •* rifampicin or rifabutin
• •* St. John's Wort
• •14. Patient is taking, or will be taking within 7 days of Day 1 of cycle 2 the following CYP3A4 substrates:
• •* terfenadine
• •* cisapride
• •* astemizole
• •* pimozide
• •15. Patient is taking, or will be taking within the 7 days of Day 1 of cycle 2 the following CYP3A4 inhibitors:
• •* clarithromycin
• •* ketoconazole, itraconazole
• •16. Patient will be taking an antiemetic within 48 hours of Day 1 of cycle 2. Prohibited antiemetics include:
• •* 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron or palonosetron)
• •* phenothiazines (e.g., prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine)
• •* butyrophenones (e.g., haloperidol or droperidol)
• •* benzamides (e.g., metoclopramide or alizapride)
• •* domperidone
• •* cannabinoids
• •* herbal therapies with potential antiemetic properties
• •* scopolamine
• •* cyclizine
• •17. Patient has used benzodiazepines or opiates, except for single daily doses of triazolam, temazepam or midazolam in the 48 hours prior to Day 1 of cycle 2. Continuation of chronic benzodiazepines or opiate therapy is permitted provided it was initiated at least 48 hours before enrollment.