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

NCT00736333 | Completed Results

• 1 other identifier: P04878
• Study Type: observational
• Target: 167
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Day 1 up to 24 weeks

Secondary Outcomes (1)

• Number of Participants With Complete Response (CR) or Partial Response (PR)

  Day 1 up to 24 weeks

Study Arms (1)

Pegylated Liposomal Doxorubicin

Subjects with metastatic breast cancer

Drug: Pegylated Liposomal Doxorubicin

Interventions

Pegylated Liposomal Doxorubicin DRUG

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

Also known as: SCH 200746

Pegylated Liposomal Doxorubicin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic breast cancer

You may qualify if:

• Patients with metastatic breast cancer

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Vice President, Global Cllinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: August 15, 2008
• Study Start: November 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 5, 2014
• Results First Posted: July 7, 2011

Record last verified: 2014-10