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

NCT ID: NCT00736333

Last Updated: 2014-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-06-30

Brief Summary

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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

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Patients selected by investigator according to clinical routine

Conditions

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Breast Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pegylated Liposomal Doxorubicin

Subjects with metastatic breast cancer

Pegylated Liposomal Doxorubicin

Intervention Type DRUG

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

Interventions

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Pegylated Liposomal Doxorubicin

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

Intervention Type DRUG

Other Intervention Names

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SCH 200746

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P04878

Identifier Type: -

Identifier Source: org_study_id

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