Breast NeoplasmNCT00736333

A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)

An observational study of Breast Neoplasm, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE). Read more about this study

Who is it for?: Any age
Conditions the study is for: Breast Neoplasm
What is being tested?: Pegylated Liposomal Doxorubicin
How many people: 167 participants
Where: No sites listed yet
Study dates: Nov 2006to Jun 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with metastatic breast cancer

Who may be able to join

Patients with metastatic breast cancer

Who cannot join

History of hypersensitivity to Caelyx or its components
Women who are pregnant or breast-feeding
Patients with severe myelosuppression

About this study

Official title: Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions

This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).

Read the detailed description

Patients selected by investigator according to clinical routine

Conditions: Breast Neoplasm
Being tested: Pegylated Liposomal Doxorubicin
Medical subject headings: Breast Neoplasms

What participants receive

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

Pegylated Liposomal DoxorubicinDrug
Also called SCH 200746
Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles

Study groups in NCT00736333
Study group	Role	What they receive
Pegylated Liposomal Doxorubicin		Subjects with metastatic breast cancer Receives: Drug: Pegylated Liposomal Doxorubicin

What is being measured

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

Number of Participants With Infusion Reactions (IR)
Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.
Measured: Day 1 up to Week 24
Percent of Participants Taking Premedication for Prevention of IR
Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.
Measured: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin
Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR
Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.
Measured: Cycles 1 & 3 (Week 4 & Week 12)
Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)
PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.
Measured: Up to 24 weeks
Number of Times Premedications Were Given for Prevention of PPE
Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.
Measured: Day 1 up to 24 weeks

Secondary outcomes (1)

Number of Participants With Complete Response (CR) or Partial Response (PR)
CR and PR were documented according to the clinical standards of each site.
Measured: Day 1 up to 24 weeks

Timeline

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

Nov 2006Jun 2010

First posted15 Aug 2008 (estimated)
Study startNov 2006
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast NeoplasmStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00736333
Sponsor's protocol ID: P04878
Status last verified: Oct 2014
First submitted: 25 Jul 2008
Last updated: 5 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Breast Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
ClinicalTrials.gov ID: NCT00736333
Acronym / sponsor ID: P04878
Conditions: Breast Neoplasm
Study type: Observational
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 15 Aug 2008 (estimated)
Results: Posted 7 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).

Detailed description

Patients selected by investigator according to clinical routine

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pegylated Liposomal Doxorubicin	–	Drug: Pegylated Liposomal DoxorubicinSubjects with metastatic breast cancer

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with metastatic breast cancer

Key inclusion criteria (1 listed)

Patients with metastatic breast cancer

Key exclusion criteria (3 listed)

History of hypersensitivity to Caelyx or its components
Women who are pregnant or breast-feeding
Patients with severe myelosuppression

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pegylated Liposomal DoxorubicinAlso: SCH 200746Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles	Drug	Pegylated Liposomal Doxorubicin

Primary outcome

Number of Participants With Infusion Reactions (IR)
Time frame: Day 1 up to Week 24
Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.
Percent of Participants Taking Premedication for Prevention of IR
Time frame: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin
Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.
Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR
Time frame: Cycles 1 & 3 (Week 4 & Week 12)
Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.
Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)
Time frame: Up to 24 weeks
PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.
Number of Times Premedications Were Given for Prevention of PPE
Time frame: Day 1 up to 24 weeks
Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.

1 secondary outcome

Number of Participants With Complete Response (CR) or Partial Response (PR)
Time frame: Day 1 up to 24 weeks

Results and safety

Results posted to the registry on 7 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pegylated Liposomal Doxorubicin	167	56

Primary outcome: Number of Participants With Infusion Reactions (IR)

Time frame: Day 1 up to Week 24. Number. Unit: Participants

Measure	Pegylated Liposomal Doxorubicin n = 160
Value	7

Population analysed: Safety population (those who received at least one dose of study medication)

Primary outcome: Percent of Participants Taking Premedication for Prevention of IR

Time frame: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin. Number. Unit: Percent of participants

Measure	Pegylated Liposomal Doxorubicin n = 160
Corticosteroids	96.3
Serotonin-3 receptor antagonists (anti-emetics)	97.5
Histamine-1 receptor blockers	15.6
Histamine-2 receptor blockers	36.3

Population analysed: Safety population (those who received at least one dose of study medication)

Primary outcome: Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR

Time frame: Cycles 1 & 3 (Week 4 & Week 12). Number. Unit: Participants

Measure	Pegylated Liposomal Doxorubicin n = 160
Value	0

Population analysed: Safety population (those who received at least one dose of study medication)

Primary outcome: Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)

Time frame: Up to 24 weeks. Number. Unit: Occurrences

Measure	Pegylated Liposomal Doxorubicin n = 160
Value	91

Population analysed: Safety population (those who received at least one dose of study medication)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pegylated Liposomal Doxorubicin	5 of 160 (3.1%)	9 of 160 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Neoplasm

Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasm, run by Merck Sharp & Dohme LLC.

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

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Infusion Reactions (IR) (time frame: Day 1 up to Week 24). The study lists 5 primary outcomes in all. 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 NCT00736333.

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 5 Nov 2014; AzTrials last refreshed its copy on 2 Nov 2026.