Status:
COMPLETED
NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer
Lead Sponsor:
Consorzio Oncotech
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study evaluates if the activity of one-day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is m...
Detailed Description
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 orall...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2017
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03862144
Start Date
May 12 2016
End Date
April 3 2017
Last Update
March 5 2019
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