Trial intelligence / Profile preview

F511 Cream for Prevention of PPE in Breast Cancer Patients Treated with PLD

NCT00992706Phase 3

Key facts

Status: Completed
Start: Sep 2009
Primary completion: Aug 2011
Countries: 1
Sponsor: Swiss Group for Clinical Cancer Research
Modality: Small Molecules

Drugs: aluminum chlorohydrate
Conditions: palmar-plantar erythrodysesthesia (PPE)

Overview

Phase 3, randomised, double-blind trial of aluminum chlorohydrate in palmar-plantar erythrodysesthesia (PPE), sponsored by Swiss Group for Clinical Cancer Research. Primary endpoint: Incidence of Palmar-plantar erythrodysesthesia grade >= 2. Started Sep 2009; status: completed.

Design

1 arm

Study design: RandomizedDouble-blind

F511 / Placebo (Split-body)
Intra-patient randomization: F511 cream on one side, Placebo on the other.

Who it enrols

Patients with metastatic breast cancer scheduled for pegylated liposomal doxorubicin monotherapy (>= 10 mg/m2/week), with no signs of PPE at entry, no cutaneous metastases on hands/feet, and able to apply cream.

Endpoints

Primary

Incidence of Palmar-plantar erythrodysesthesia grade >= 2Until PPE grade >=2

Secondary

Patient-reported outcomeUntil PPE grade >=2
Adverse skin reaction to local therapyUntil PPE grade >=2
Extent of symptom reliefUntil PPE grade >=2
Recurrence of PPE grade >= 2Until PPE grade >=2

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