F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer

• Patient-reported outcome [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]
• Adverse skin reaction to local therapy [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: Yes ]
• Extent of symptom relief [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]
• Recurrence of PPE grade ≥ 2 [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]

• Patient-reported outcome [ Designated as safety issue: No ]
• Adverse skin reaction to local therapy [ Designated as safety issue: Yes ]
• Extent of symptom relief [ Designated as safety issue: No ]
• Recurrence of PPE grade ≥ 2 [ Designated as safety issue: No ]

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.

• Breast Cancer
• Palmar-plantar Erythrodysesthesia

• Drug: antiperspirant cream F511
  Placebo and verum cream once daily, in the morning, during the first week of the first PLD treatment only, then once daily, three times per week (in the morning). Tube R for right hand and foot, tube L for left hand and foot.
• Drug: pegylated liposomal doxorubicin hydrochloride
  According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic breast cancer

  • No cutaneous metastases on hands or feet

• Pegylated liposomal doxorubicin hydrochloride monotherapy is indicated according to the local investigator

  • Planned dose at least 10 mg/m^2 per week
• No sign of palmar-plantar erythrodysesthesia (PPE) at study entry

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Able to apply topical medication (cream) or provide for another person to apply cream
• Not pregnant or breastfeeding
• Fertile patients must use effective contraception during trial participation and for 1 month after completion
• Negative pregnancy test
• Compliant and geographically proximal in order to allow proper evaluation and follow-up
• No dermatologic conditions (e.g., psoriasis) that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
• No known allergy or hypersensitivity to F511 cream

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 30 days since prior and no concurrent treatment with other experimental drugs or anticancer therapy
• More than 30 days since prior and no concurrent treatment on another clinical trial
• No concurrent local use of other ointments or creams for hands or feet other than Excipial Repair®