Clinical trial · Interventional
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response
NCT01649258CI-TRIAL-00030417terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Efficacy
Summary
Brief summary (as posted)
This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal system work in preventing nausea and vomiting in patients with breast cancer undergoing chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy
Conditions
Conditions (3)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Nausea | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fosaprepitant dimeglumine | Drug | — | UNRESOLVED |
| granisetron transdermal system | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (antiemetics)
- description
- Patients receive granisetron transdermal system patch 24-48 hrs before the initiation of chemotherapy. Patients wear the granisetron transdermal system patch for 7 days. Patients receive fosaprepitant dimeglumine IV over 15 minutes on day 1 of chemotherapy. Treatment repeats every 2 or 3 weeks for up to 4 courses in the absence of unacceptable toxicity.
- interventionNames
- Drug: granisetron transdermal system
- Drug: fosaprepitant dimeglumine
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Proportion of patients with complete response, defined as no emesis and no use of rescue medication in acute phase (within first 24 hours of treatment)
- timeFrame
- Within the first 24 hours of treatment
- description
- The complete response rate with the exact 95% confidence intervals (CIs) will be calculated. The associations between the complete response rate and patient characteristics and biomarkers will be examined using Fisherâs exact test or Mann-Whitney U test whenever appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed breast cancer scheduled to receive chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Projected life expectancy of at least 3 months * Provision of informed consent prior to any study-related procedures * Negative pregnancy test for women of childbearing potential * Absolute neutrophil count (ANC) \>= 1500/mm\^3 * Platelet count \>= 100,000 cells/mm\^3 * Hemoglobin \>= 9.0g/dL * Serum creatinine =\< 1.5 mg/dl * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 X upper limit of normal (ULN) * Alkaline phosphatase =\< 2.5 X upper limit of normal; in patients with bone metastasis and no evidence of liver metastasis and bilirubin =\< upper limit of normal an alkaline phosphatase =\< 5 ULN will be allowed * Serum bilirubin =\< 1.0 mg/dL * No other concomitant therapy directed at the cancer is allowed Exclusion Criteria: * Allergy or intolerance to 5HT3 or NK-1 antagonists and dexamethasone * Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours prior to day 1 of the study * Use of anticoagulant agent (Warfarin, Coumadin, Jantoven, Marevan, Lawarin, Waran, or Warfant) * An episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy * Severe concurrent illness other than neoplasia * Gastrointestinal obstruction or an active peptic ulcer * Patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
References
Publications (0)
Data not yet available
No reference posted for this study.