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Breast CancerPhase 3NCT00992706

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

A Phase 3 study testing antiperspirant cream F511 and pegylated liposomal doxorubicin hydrochloride in people with Breast Cancer and Palmar-plantar Erythrodysesthesia, run by Swiss Cancer Institute at 15 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
antiperspirant cream F511 and pegylated liposomal doxorubicin hydrochloride
How many people
91 participants
Where
15 sitesSwitzerland
Study dates
Sep 2009to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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®

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Switzerland15 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Spitalzentrum Biel

    Biel, CH-2501

  • Spital Buelach

    Bülach, CH-8180

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital Luzern

    Luzerne, CH-6000

  • Kantonsspital Olten

    Olten, CH-4600

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Onkologie Schaffhausen

    Schaffhausen, CH-8200

  • Institut Central des Hopitaux Valaisans

    Sion, CH-1951

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial

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.

Read the 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.

Being tested
antiperspirant cream F511, pegylated liposomal doxorubicin hydrochloride
Keywords
palmar-plantar erythrodysesthesia, stage IV breast cancer, male breast cancer
Medical subject headings
Breast Neoplasms, Hand-Foot Syndrome, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • antiperspirant cream F511Drug

    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.

  • pegylated liposomal doxorubicin hydrochlorideDrug

    According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2

    Measured: Until PPE grade ≥2

Secondary outcomes (4)

  1. Patient-reported outcome

    Measured: Until PPE grade ≥2

  2. Adverse skin reaction to local therapy

    Measured: Until PPE grade ≥2

  3. Extent of symptom relief

    Measured: Until PPE grade ≥2

  4. Recurrence of PPE grade ≥ 2

    Measured: Until PPE grade ≥2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionAug 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00992706
Sponsor's protocol ID
SAKK 92/08
Other IDs
SWS-SAKK-92/08, EU-20978, CDR0000652808
Status last verified
May 2019
First submitted
8 Oct 2009
Last updated
15 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Templeton 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.

    PubMed 24656636

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing antiperspirant cream F511 and pegylated liposomal doxorubicin hydrochloride in people with Breast Cancer and Palmar-plantar Erythrodysesthesia, run by Swiss Cancer Institute at 15 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2 (time frame: Until PPE grade ≥2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00992706, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.

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