Clinical trial · Interventional
Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer
Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
- 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 randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.
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 |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Netupitant/Palonosetron Hydrochloride | Drug | — | UNRESOLVED |
| Olanzapine | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Prochlorperazine | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group I (netupitant/palonosetron hydrochloride, dexamethasone
- description
- Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
- interventionNames
- Drug: Dexamethasone
- Other: Laboratory Biomarker Analysis
- Drug: Netupitant/Palonosetron Hydrochloride
- Other: Placebo
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Group II (net/pal hydro, dexa, prochlorperazine, placebo)
- description
- Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
- interventionNames
- Drug: Dexamethasone
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a diagnosis of breast cancer and be chemotherapy naive; NOTE: prior methotrexate for non-cancerous conditions is allowed * Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin. Single-day chemotherapy is defined as only one infusion or injection per cycle. Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens * Be scheduled to receive an antiemetic regimen that does not contain Akynzeo; in addition, the antiemetic regimen must conform with American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines at cycle 1 * Be able to read English * Have the ability to give written informed consent * Have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * NOTE: patients 80 years of age or older must have approval from an oncologist or their designee to participate in this study * NOTE: patients currently receiving warfarin must have approval from an oncologist or their designee to participate in this study * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for the duration of the study and have a negative pregnancy test within 10 days prior to the initiation of chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately * CYCLE II PORTION ONLY: Only participants with a nausea score \>= 3 at least once on the diary assessment from cycle 1 can be randomized for cycle 2 * CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1 Exclusion Criteria: * Have clinical evidence of current or impending bowel obstruction * Have a known history of central nervous system disease (e.g., brain metastases or a seizure disorder) * Have dementia * Have uncontrolled diabetes mellitus or uncontrolled hyperglycemia * Have severe hepatic impairment, severe renal impairment, or end-stage renal disease as determined by the treating physician * Have had long term treatment (\> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =\< 5 days) * Have a known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months * Be taking benzodiazepines regularly (\> 5 days within the past 30 days); pro re nata (PRN) use (=\< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms, or as a rescue medication for breakthrough CINV is allowed * Be taking anticholinergic medications * Be receiving quinolone antibiotic therapy * Be taking amifostine (Ethiofos) * Have a known hypersensitivity to olanzapine or to phenothiazines * CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 1 * CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1
References
Publications (0)
Data not yet available