Phase 3
N=317
Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer
Breast Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03367572 ↗Enrolled (actual)
317
Serious AEs
2.3%
Results posted
Sep 2025
Primary outcome: Primary: Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm) — 4.51; 4.70; 4.93; 3.22 units on a scale — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Laboratory Biomarker Analysis (Other); Netupitant/Palonosetron Hydrochloride (Drug); Olanzapine (Drug); Placebo (Other); Prochlorperazine (Drug); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester NCORP Research Base
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm) |
4.51; 4.70; 4.93; 3.22; 2.68; 2.37 | 0.008 sig |
| PRIMARY Average Nausea Defined as the [AVERAGE] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm) |
2.40; 2.58; 2.50; 1.90; 1.62; 1.45 | 0.010 sig |
| SECONDARY The Secondary Outcome Variable Will be [ MAXIMUM ] Nausea (Measured on a 7-point Scale Anchored by ("1:Not at All Nauseated" and 7:"Extremely Nauseated"). Difference of Average Nausea Between Control and Experimental Arms Will be Calculated and Compared. |
4.51; 4.70; 4.93; 3.22; 2.68; 2.37 | 0.019 sig |
| SECONDARY Vomiting (Yes/No) at Cycle 2 in Participants Who Experienced CINV at Cycle 1. |
7; 4; 2; 79; 103; 98 | 0.386 |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03367572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.