Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer

Breast Cancer, Metastatic Breast Cancer Clinical Trial

Official title:

Safety of Herceptin in Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424682
• Other study ID #: ML21201
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: November 1, 2016
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Agency for Medicines and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer, Metastatic Breast Cancer
• Breast Neoplasms

Intervention

Other:
• No intervention
No intervention administered in this study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs)		Up to 2 years	No
Primary	Percentage of Participants with Serious Adverse Events (SAEs)		Up to 2 years	No
Primary	Percentage of Deaths		Up to 2 years	No
Secondary	Percentage of Participants with Serious Adverse Events (SAEs), Who Experienced Progression of Disease		Up to 2 years	No