Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy

• 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) [ Time Frame: Within the first 24 hours of treatment ] [ Designated as safety issue: No ]
  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.
  
  
• Proportion of patients with complete response, defined as no emesis and no use of rescue medication in delayed phase (within 2-4 days of treatment) [ Time Frame: Up to day 4 ] [ Designated as safety issue: No ]
  The complete response rate with the exact 95% 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.
  
  
• Proportion of patients with complete response, defined as no nausea, defined as Visual Analog Scale (VAS) less than 5 mm on a 0-100mm horizontal scale in acute phase (within 24 hours of treatment) [ Time Frame: Within the first 24 hours of treatment ] [ Designated as safety issue: No ]
  The complete response rate with the exact 95% 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.
  
  
• Proportion of patients with complete response, defined as no nausea, defined as VAS less than 5 mm on a 0-100mm horizontal scale in delayed phase (within 2-4 days of treatment) [ Time Frame: Up to day 4 ] [ Designated as safety issue: No ]
  The complete response rate with the exact 95% 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.
  
  

• Proportion of patients with partial response, defined as 2 or fewer episodes of emesis (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0 grade 1-2), regardless of the use of rescue antiemetic medications (in acute and delayed phase) [ Time Frame: Up to day 4 ] [ Designated as safety issue: No ]
  Standard descriptive statistics will be used to display associations and test these associations (Fisherâs exact, Spearman correlations or the Kruskall-Walis test) between these measures of emesis and patient information, such as age, history of alcohol use, history of motion/morning sickness, stage of disease, treatment setting (neoadjuvant versus adjuvant), emesis experienced with prior exposure to chemotherapy, concomitant medication in detail, and whether or not rescue medications were used.
  
  
• Proportion of patients with treatment failures, defined as more than 2 episodes of emesis (CTCAE version 4.0 grade 2 or greater), regardless of the use of rescue antiemetic medications [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  Standard descriptive statistics will be used to display associations and test these associations (Fisherâs exact, Spearman correlations or the Kruskall-Walis test) between these measures of emesis and patient information, such as age, history of alcohol use, history of motion/morning sickness, stage of disease, treatment setting (neoadjuvant versus adjuvant), emesis experienced with prior exposure to chemotherapy, concomitant medication in detail, and whether or not rescue medications were used.
  
  
• Proportion of patients with partial response, defined as no significant nausea, defined as VAS less than 25 mm on a 0-100mm horizontal scale (in acute and delayed phase) [ Time Frame: Up to day 4 ] [ Designated as safety issue: No ]
  Standard descriptive statistics will be used to display associations and test these associations (Fisherâs exact, Spearman correlations or the Kruskall-Walis test) between these measures of emesis and patient information, such as age, history of alcohol use, history of motion/morning sickness, stage of disease, treatment setting (neoadjuvant versus adjuvant), emesis experienced with prior exposure to chemotherapy, concomitant medication in detail, and whether or not rescue medications were used.
  
  
• Proportion of patients who developed nausea and vomiting in the first course of treatment out of all enrolled patients [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: No ]
  Standard descriptive statistics will be used to display associations and test these associations (Fisherâs exact, Spearman correlations or the Kruskall-Walis test) between these measures of emesis and patient information, such as age, history of alcohol use, history of motion/morning sickness, stage of disease, treatment setting (neoadjuvant versus adjuvant), emesis experienced with prior exposure to chemotherapy, concomitant medication in detail, and whether or not rescue medications were used.
  
  
• Proportion of patients who developed grade 1, 2, 3, or 4 nausea and vomiting with all courses of treatment out of all patients who developed nausea and vomiting [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  Standard descriptive statistics will be used to display associations and test these associations (Fisherâs exact, Spearman correlations or the Kruskall-Walis test) between these measures of emesis and patient information, such as age, history of alcohol use, history of motion/morning sickness, stage of disease, treatment setting (neoadjuvant versus adjuvant), emesis experienced with prior exposure to chemotherapy, concomitant medication in detail, and whether or not rescue medications were used.
  
  
• Proportion of patients who developed nausea and vomiting on all courses [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  Standard descriptive statistics will be used to display associations and test these associations (Fisherâs exact, Spearman correlations or the Kruskall-Walis test) between these measures of emesis and patient information, such as age, history of alcohol use, history of motion/morning sickness, stage of disease, treatment setting (neoadjuvant versus adjuvant), emesis experienced with prior exposure to chemotherapy, concomitant medication in detail, and whether or not rescue medications were used.
  
  
• Proportion of patients who experience grade 1, 2, 3, or 4 adverse events out of all patients who have received study drugs [ Time Frame: Up to 30 days after the last dose of study drug ] [ Designated as safety issue: No ]
  All toxicities will be summarized on an on-going basis. Standard descriptive statistics will be used to display associations and test these associations (Fisherâs exact, Spearman correlations or the Kruskall-Walis test) between these measures of emesis and patient information, such as age, history of alcohol use, history of motion/morning sickness, stage of disease, treatment setting (neoadjuvant versus adjuvant), emesis experienced with prior exposure to chemotherapy, concomitant medication in detail, and whether or not rescue medications were used.
  
  
• Proportion of patients who missed 0, 1, or more than 2 doses of scheduled antiemetic medication at home on days 2 to 3, out of all patients [ Time Frame: Up to day 3 ] [ Designated as safety issue: No ]
  Standard descriptive statistics will be used to display associations and test these associations (Fisherâs exact, Spearman correlations or the Kruskall-Walis test) between these measures of emesis and patient information, such as age, history of alcohol use, history of motion/morning sickness, stage of disease, treatment setting (neoadjuvant versus adjuvant), emesis experienced with prior exposure to chemotherapy, concomitant medication in detail, and whether or not rescue medications were used.
  
  

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of the combination of fosaprepitant (fosaprepitant dimeglumine) and granisetron transdermal system in the prevention of acute and delayed chemotherapy induced nausea and vomiting in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.

SECONDARY OBJECTIVE:

I. To evaluate the safety of the combination of fosaprepitant and granisetron transdermal system in breast cancer patients undergoing adjuvan or neoadjuvant chemotherapy.

EXPLORATORY OBJECTIVE:

I. To explore the use of single nucleotide polymorphisms (SNPs) in the 5âhydroxytryptamine-3 (5HT3) and neurokinin-1 (NK-1) receptors as potential markers of efficacy.

OUTLINE: 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 intravenously (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.