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

Phase 3

Completed

• Conditions: Breast Cancer; Palmar-plantar Erythrodysesthesia

• Registration Number: NCT00992706
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Primary Completion: 2011-08
• Study Completion: 2012-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2	Until PPE grade ≥2

Secondary Outcome Measures

Name	Time	Method
Extent of symptom relief	Until PPE grade ≥2
Recurrence of PPE grade ≥ 2	Until PPE grade ≥2
Adverse skin reaction to local therapy	Until PPE grade ≥2
Patient-reported outcome	Until PPE grade ≥2

Trial Locations

Locations (15)

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Spital Buelach; 🇨🇭 Bulach, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital Luzern; 🇨🇭 Luzerne, Switzerland

Institut Central des Hopitaux Valaisans; 🇨🇭 Sion, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland

Kantonsspital Olten; 🇨🇭 Olten, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Spitalzentrum Biel; 🇨🇭 Biel, Switzerland

Onkologie Schaffhausen; 🇨🇭 Schaffhausen, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland