Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer

Completed

• Conditions: Breast Cancer, Metastatic Breast Cancer
• Interventions: Other: No intervention

• Registration Number: NCT02424682
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study was designed to evaluate safety and tolerability of Herceptin as treatment for patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2 positive metastatic breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-23
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• Confirmed diagnosis of metastatic breast cancer (BC) with HER2-neu overexpression
• Left Ventricular Ejection Fraction (LVEF) by ECHO or Multi Gated Acquisition Scan (MUGA) > 50%
• Good performance status: Eastern Cooperative Oncology Group (ECOG) scale < or = 2 and life expectancy > or = 12 weeks

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Exclusion Criteria

• Advanced pulmonary disease and severe dyspnea
• Abnormal laboratory within 14 days prior to registration
• Peripheral neuropathy > grade 2
• Presence of central nervous system (CNS) metastasis
• Pregnancy or lactating

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HER 2 positive metastatic breast cancer	No intervention	HER 2 positive metastatic breast cancer treated with Herceptin as per registered indication, until disease progression.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Serious Adverse Events (SAEs)	Up to 2 years
Percentage of Deaths	Up to 2 years
Percentage of Participants with Adverse Events (AEs)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Serious Adverse Events (SAEs), Who Experienced Progression of Disease	Up to 2 years