Clinical trial · Interventional
F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Palmar-plantar Erythrodysesthesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antiperspirant cream F511 | Drug | — | UNRESOLVED |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2
- timeFrame
- Until PPE grade ≥2
Secondary outcomes (4)
- measure
- Patient-reported outcome
- timeFrame
- Until PPE grade ≥2
- measure
- Adverse skin reaction to local therapy
- timeFrame
- Until PPE grade ≥2
- measure
- Extent of symptom relief
- timeFrame
- Until PPE grade ≥2
- measure
- Recurrence of PPE grade ≥ 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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®
References
Publications (1)
- RESULTTempleton AJ, Ribi K, Surber C, Sun H, Hsu Schmitz SF, Beyeler M, Dietrich D, Borner M, Winkler A, Muller A, von Rohr L, Winterhalder RC, Rochlitz C, von Moos R, Zaman K, Thurlimann BJ, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK) Coordinating Center. Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08). Breast. 2014 Jun;23(3):244-9. doi: 10.1016/j.breast.2014.02.005. Epub 2014 Mar 20. PMID 24656636