Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2
Until PPE grade ≥2
Thomas Ruhstaller, MD
Kantonsspital St. Gallen