Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT03367572

Run by

University of Rochester NCORP Research Base

People needed

1363

Starts

2018-04-19

Expected to finish

2024-04-13

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hawaii MU NCORP — Honolulu, Hawaii, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Gulf South MU-NCORP — New Orleans, Louisiana, United States
• Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• Cancer Research Consortium of West Michigan — Grand Rapids, Michigan, United States
• Health Partners Inc — Minneapolis, Minnesota, United States
• Cancer Research for the Ozarks NCORP — Springfield, Missouri, United States
• Nevada Cancer Research Foundation NCORP — Las Vegas, Nevada, United States
• University of Rochester NCORP Research Base — Rochester, New York, United States
• Southeast Clinical Oncology Research Program — Winston-Salem, North Carolina, United States
• Columbus NCORP — Columbus, Ohio, United States
• Dayton Clinical Oncology Program — Dayton, Ohio, United States
• Geisinger Cancer Institute NCORP — Danville, Pennsylvania, United States
• Greenville NCORP — Greenville, South Carolina, United States
• Upstate Carolina NCORP — Spartanburg, South Carolina, United States
• Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
• Gundersen Health System — La Crosse, Wisconsin, United States
• Aurora NCORP — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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