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

Conditions: This is a non-inferiority study in chemotherapy-naive female patients with breast cancer, age 18 years or older, who are scheduled to receive moderately emtogenic chemotherapy MEC
MedDRA version: 6.1Level: PTClassification code 10006279
MedDRA version: 9.1Level: LLTClassification code 10006279Term: Breast neoplasm

Registration Number: EUCTR2005-002643-89-IT

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 8805;18 years; Patients with histologically or cytologically confirmed breast cancer BC , requiring Chemotherapy, who are na ve to chemotherapy; Scheduled to receive of a single dose of a MEC regimen on Day 1. Karnofsky Performance Status grade of 8805;60 see Appendix A ; 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 8804;2 times the upper limit of normal ULN and renal function creatinine 8804;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 see Appendix B ; 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