Clinical trial NCT02336750 (phase 3, status: unknown status)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: aprepitant, mirtazapine
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, CN1CCN2C(C1)C1=CC=CC=C1CC1=C2N=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Patients who had delayed emesis after receiving AC regimen or regimens including
             cisplatin, and will subsequently accept the same chemotherapy regimens

          2. Karnofsky Performance Status ≥60.

          3. Life expectancy of more than 3 months.

          4. Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥
             1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤
             3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases),
             Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>60ml/min

          5. Be able to read, understand and complete the questionnaire and diary, including FLIE
             and Food Diary. Note: Must be able to understand written Chinese.

          6. Be able to understand the study procedures and sign informed consent.

          7. Meet one of the followings about contraception:

        For fertile women：

          1. Urine pregnancy test in screening should be negative. If urine pregnancy test is
             positive, the patient could be enrolled only when serum pregnancy test is negative.

          2. They should agree to abstinence or use double barrier methods of contraception during
             the research, within at least 14 days before enrolling and one month after the last
             dose of study medicine.

          3. If taking oral contraceptives, the patient should agree to add a barrier method of
             contraception during the research, within at least 14 days before enrolling and one
             month after the last dose of study medicine.

        Unfertility is defined as anyone of the followings:

          1. Natural menopausal (natural menopausal ≥6 months and the serum FSH in the
             Postmenopausal range, or natural menopausal ≥12 months and age >45)

          2. Bilateral tubal ligation

          3. 6 weeks after the bilateral oophorectomy (with or without hysterectomy )

        Exclusion Criteria:

          1. Treatment with any other study medicine within 4 weeks before enrollment and with
             unrecovered toxicities.

          2. Women of reproductive age (including gestation period, lactation, a desire of
             pregnancy, oral contraceptives only)

          3. Severe visceral disease: such as history of myocardial infarction or serious epilepsy
             needing medicine.

          4. Mental disabilities or emotional or mental disorders.

          5. Another malignancy within 5 years (except for cured basal cell carcinoma of the skin
             and cervical carcinoma).

          6. Uncontrolled disease, such as active infections (pneumonia), diabetic ketoacidosis,
             gastrointestinal obstruction. And other cases which would cause bias or make patients
             exposed to unnecessary risks.

          7. Receiving any dose of systemic glucocorticoid treatment, but local or inhaled
             corticosteroids is allowed.

          8. Benzodiazepines or opioids treatment within 48 hours before the first day of the
             study, except for a single daily taking of triazolam, temazepam or midazolam.

             a)Benzodiazepines or opioids given 48 hours or longer before the first day of the
             study are allowed and patients can continue the medication.

          9. Having vomiting, retching or nausea within 24 hours before cisplatin treatment on the
             first day of the study.

         10. Patient will receive abdominal or pelvic radiation between a week before and 6 days
             after the initiation of the study.

         11. Prior aprepitant treatment or hypersensitivity history to any components of the study
             drug.

         12. Cannot swallow capsules.

         13. Not eligible for the study based on the investigators.

         14. Patients receiving strong inducers of CYP3A4, such as carbamazepine, dipheninum,
             phenobarbitone, etc..