Clinical trial · Interventional
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
NCT03862144CI-TRIAL-00037428GIM15-NEPAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Netupitant/Palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Netupitant/Palonosetron & Dexamethasone
- description
- * Netupitant/Palonosetron (NEPA) will be administered orally at the dose of 300 MG (milligrams) 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.
- interventionNames
- Drug: Netupitant/Palonosetron
Primary outcomes (1)
- measure
- Complete response
- timeFrame
- During the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles (each cycle is 21 days)
- description
- The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase of all AC-based chemotherapy cycles
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women ≥ 18 years old 2. Histologically or cytologically confirmed diagnosis of breast cancer 3. Naïve patients 4. Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen) 5. ECOG (Eastern Cooperative Oncology Group) performance status 0-2 6. Body Mass index (BMI) ≥ 18.5 7. Written informed consent 8. 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 9. 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); 10. Ability and willingness of the patient to complete the diary. Exclusion Criteria: 1. Advanced/metastatic breast cancer 2. Patients already submitted to non-AC-based chemotherapy 3. Treatment with investigational medications in 30 days before NEPA 4. Myocardial infarction within the last 6 months 5. Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients 6. Uncontrolled diabetes mellitus 7. Nausea and vomiting at baseline 8. Chronic use of other antiemetic agent(s) 9. Patient's inability to take oral medication 10. Gastrointestinal obstruction or active peptic ulcer 11. Pregnancy or breastfeeding 12. 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 13. Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol
References
Publications (1)
- DERIVEDCaputo R, Cazzaniga ME, Sbrana A, Torrisi R, Paris I, Giordano M, Montesarchio V, Guarneri V, Amaducci L, Bilancia D, Cilenti G, Fabi A, Collova E, Schirone A, Bonizzoni E, Celio L, De Placido S, De Laurentiis M. Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study. BMC Cancer. 2020 Mar 19;20(1):232. doi: 10.1186/s12885-020-6707-9. PMID 32188417