Trials / Completed
CompletedNCT03862144
NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer
One Day Antiemetic Prophylaxis of NEPA (Netupitant Plus Palonosetron) and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving an AC-based Chemotherapy Regimen
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Consorzio Oncotech · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 maintained during all the chemotherapy cycle treatment (maximum 4 cycles).
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Netupitant/Palonosetron |
Timeline
- Start date
- 2016-05-12
- Primary completion
- 2017-04-03
- Completion
- 2017-04-03
- First posted
- 2019-03-05
- Last updated
- 2019-03-05
Source: ClinicalTrials.gov record NCT03862144. Inclusion in this directory is not an endorsement.