Double-blind Study to Compare the Efficacy of Palonosetron with or without the use of Dexamethasone on Days 2 and 3, in the Prevention of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy (MEC) Given to Female Patients with Breast Cancer - PALO 05-02

Conditions: This is a non-inferiority study in chemotherapy-naïve female patients with breast cancer, age 18 years or older, who are scheduled to receive Moderately Emetogenic Chemotherapy (MEC).

Registration Number: EUCTR2005-002643-89-ES

Lead Sponsor: Helsinn Healthcare SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

Patients that meet all of the following criteria may be enrolled into the study:
• Willing and able to sign informed consent and complete the patient diary;
• Females age =18 years;
• Patients with histologically or cytologically confirmed breast cancer (BC), requiring Chemotherapy, who are naïve to chemotherapy;
• Scheduled to receive of a single dose of a MEC regimen on Day 1.
• Karnofsky Performance Status grade of =60;
• Life-expectancy greater than 3 months;
• For women of child-bearing potential, negative serum or urine pregnancy test within 2 weeks of treatment and use of physician-approved method of birth control
throughout the study;
• Acceptable hepatic function (=2 times the upper limit of normal [ULN]) and renal
function (creatinine =1.5 times ULN).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prior treatment with palonosetron;
• Known hypersensitivity reaction to any 5-HT3 receptor antagonists;
• Know hypersensitivity to dexamethasone;
• Prior treatment with chemotherapy;
• Scheduled receipt of MEC, radiotherapy, or HEC (according to the Hesketh
classification level 3 or higher) on Days 2 to 6;
• Anti-emetic therapy (within 24 hours of treatment initiation) or scheduled receipt of up to Day 5) of any drug with antiemetic effects;
• Nausea or vomiting with an National Cancer Institute (NCI) Common Toxicity
• Symptomatic brain metastases;
• Gastric outlet or intestinal obstruction;
• Known current or history of drug or alcohol abuse;
• Participation in another study within 30 days of (before or after) study entry.
Criteria (CTC) of grade 2 or 3 in the 24 hours before receiving study medication (see Appendix C)
• Ongoing vomiting from any other organic etiology
• Female patients who are pregnant or breast feeding
• History of seizures