A Prospective, Open Label, Non-comparative Trial to Determine the Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With the Docetaxel-Cyclophosphamide Regimen in Early Breast Cancer Patients
1. Female patient ≥ 18 years of age.
2. Patient has a histological confirmed early-stage (I to III) breast cancer.
3. Patient is able to understand study procedures and agrees to participate in the study
by giving written informed consent.
4. Patient is naïve to moderate or highly emetogenic chemotherapy per Hesketh criteria
(see Appendix 7.1).
5. Patient is scheduled to receive of chemotherapy with Docetaxel-Cyclophosphamide
(Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2) administered every 21 days.
6. Patient has a predicted life expectancy ≥ 4 months.
7. Functional State 0-1 ECOG Scale (see Appendix 12.2).
8. Patient has an adequate organ function including the following:
- Bone marrow reserve: Absolute Neutrophil Count >1500/mm3 and WBC count
>3000/mm3; Platelet Count >100.000/mm3
- Hepatic: AST (aspartate transaminase) <2.5 x upper limit of normal; ALT (alanine
transaminase) <2.5 x upper limit of normal; Bilirubin within the normal limit.
- Renal: Creatinine <1.5 x upper limit of normal.
9. Premenopausal female patients must demonstrate a negative serum and/or urine
pregnancy test within 3 days of study drug administration, and agree to use a
double-barrier form of contraception for at least 14 days prior to, throughout and
for at least 14 days following the last dose of study medication. Women taking oral
contraceptive agents must agree to add a barrier form of contraception. Abstinence is
also considered an acceptable form of contraception. (Note: A female patient who is
not of reproductive potential is eligible without requiring the use of contraception.
A female patient who is not of reproductive potential is defined as one who has
either: 1) reached natural menopause (defined as 6 months of spontaneous amenorrhea
with serum FSH levels in the postmenopausal range as determined by the laboratory, or
12 months of spontaneous amenorrhea); 2) 6 weeks post surgical bilateral oophorectomy
with or without hysterectomy; or 3) bilateral tubal ligation.)
10. Patient is able to read, understand and complete study questionnaires.
1. Patient is scheduled to receive any chemotherapy treatment different to the
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 (see Appendix 7.1).
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
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
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
- 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
15. Patient is taking, or will be taking within the 7 days of Day 1 of cycle 2 the
following CYP3A4 inhibitors:
- ketoconazole, itraconazole
16. Patient will be taking an antiemetic within 48 hours of Day 1 of cycle 2. Prohibited
- 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron or
- phenothiazines (e.g., prochlorperazine, fluphenazine, perphenazine,
thiethylperazine, or chlorpromazine)
- butyrophenones (e.g., haloperidol or droperidol)
- benzamides (e.g., metoclopramide or alizapride)
- herbal therapies with potential antiemetic properties
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 iniciated at least 48 hours before enrollment.