A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer

This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.

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Key information

Conditions

Breast Cancer, Early Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kamenitz, 21204, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female patients > or = 18 years of age
Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression
Previously treated with adjuvant antracycline containing chemotherapy
Left Ventricular Ejection Fraction (LVEF) > 50%
Eastern Cooperative Oncology Group (ECOG) score < or = 2
Life expectancy > or = 12 weeks

Exclusion criteria

Left Ventricular Ejection Fraction (LVEF) < 50%
Advanced pulmonary disease
Severe dyspnea
Abnormal laboratory results within 14 days prior to registration
Peripheral neuropathy
Presence of Central Nervous System (CNS) metastasis

Treatment and study plan

No intervention

Other

Primary outcomes

Percentage of participants with adverse events

Time frame: Up to 3 years
Percentage of participants with serious adverse events

Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: May 13, 2015
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed