Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer

PRIMARY OBJECTIVES:

I. To determine the proportion of patients achieving a complete response (CR), defined as no
emesis and no rescue medications in the 0-24 hour time period following weekly intravenous
doxorubicin.

SECONDARY OBJECTIVES:

I. To determine the proportion of patients achieving a complete response (CR), defined as no
emesis and no rescue medications in the 24-120 hour time period following weekly intravenous
doxorubicin.

II. To determine the proportion of patients achieving a complete response (CR), defined as
no emesis and no rescue medications in the 0-120 hour time period following weekly
intravenous doxorubicin.

III. To determine the number of emetic episodes daily and cumulatively for the 24-120, and
0-120 hour time periods.

IV. To determine the time to first emetic episode. V. To determine the time to first
administration of rescue medication. VI. To determine the time to treatment failure (time to
first emetic episode or administration of rescue medication, whichever occurred first).

VII. To determine the number of doses of rescue medications used. VIII. To determine the
side effects of antiemetic medications used. IX. To determine the severity of nausea. X. To
evaluate quality of life.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days
1-7.

GROUP I: Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to
each dose of doxorubicin hydrochloride).

GROUP II: Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to
each dose of doxorubicin hydrochloride).

Treatment repeats every 7 days for 12-15 courses in the absence of disease progression or
unacceptable toxicity.