NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer

Patients included in the study should be treated with the following antiemetic prophylaxis, during all the AC-based chemotherapy cycles, up to a maximum of 4 cycles:

• NEPA will be administered orally at the dose of 300 mg netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle.
• Dexamethasone 12 mg will be added on day 1 only of each cycle.

Inclusion criteria

• Women ≥ 18 years old
• Histologically or cytologically confirmed diagnosis of breast cancer
• Naïve patients
• Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen)
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2
• Body Mass index (BMI) ≥ 18.5
• Written informed consent
• If women of childbearing potential age: reliable contraceptive measures must be used during the study treatment period and up to 30 days after last NEPA administration
• Acceptable hepatic function (<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine < 1.5 times the upper limit of normal);
• Ability and willingness of the patient to complete the diary.

Exclusion criteria

• Advanced/metastatic breast cancer
• Patients already submitted to non-AC-based chemotherapy
• Treatment with investigational medications in 30 days before NEPA
• Myocardial infarction within the last 6 months
• Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients
• Uncontrolled diabetes mellitus
• Nausea and vomiting at baseline
• Chronic use of other antiemetic agent(s)
• Patient's inability to take oral medication
• Gastrointestinal obstruction or active peptic ulcer
• Pregnancy or breastfeeding
• Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for ≥ 5 years
• Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol