Breast Cancer Clinical Trial
Official title:
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
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
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.
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