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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00736333

Enrollment

167

Registered

2008-08-15

Start date

2006-11-30

Completion date

2010-06-30

Last updated

2014-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

Brief 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).

Detailed description

Patients selected by investigator according to clinical routine

Interventions

DRUGPegylated Liposomal Doxorubicin

Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m\^2, given for up to 6 cycles

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with metastatic breast cancer

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Infusion Reactions (IR)	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	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	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)	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	Day 1 up to 24 weeks	Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.

Secondary

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

Participant flow

Participants by arm

Arm	Count
Pegylated Liposomal Doxorubicin Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles	160
Total	160

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Data Missing	2
Overall Study	Death	7
Overall Study	Did Not Receive Drug or Not Documented	7
Overall Study	Other	4
Overall Study	Toxicity	6
Overall Study	Tumor Progression	75
Overall Study	Withdrawal by Subject	10

Baseline characteristics

Characteristic	Pegylated Liposomal Doxorubicin
Age, Continuous	62 years STANDARD_DEVIATION 12
Sex: Female, Male Female	159 Participants
Sex: Female, Male Male	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	9 / 160
serious Total, serious adverse events	5 / 160

Outcome results

Primary

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.

Time frame: Up to 24 weeks