Breast Cancer Clinical Trial
Official title:
Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial
RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women
receiving doxorubicin hydrochloride liposome for metastatic breast cancer.
PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works
compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients
receiving doxorubicin hydrochloride liposome for metastatic breast cancer.
OBJECTIVES:
- Evaluate the effects of F511 cream on the occurrence of palmar-plantar
erythrodysesthesia (PPE) in patients with metastatic breast cancer treated with
pegylated liposomal doxorubicin hydrochloride.
OUTLINE: This is a multicenter study.
Patients receive pegylated liposomal doxorubicin hydrochloride according to local practice on
1, 2, or 4 weeks course schedules with at least 10 mg/m^2 per week allowed.
Patients apply F511 cream on one side, hand and foot and the corresponding placebo on the
other side hand and foot once daily (the morning) during the first week of the first
pegylated liposomal doxorubicin hydrochloride treatment only, then once daily, three times
per week thereafter. Treatment continues throughout chemotherapy administration in the
absence of palmar-plantar erythrodysesthesia (PPE) ≥ grade 2
After completion of study therapy, patients are followed for 30 days. Patients with PPE ≥
grade 2 are followed until the PPE resolves to ≤ grade 1.
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