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OpenTrials
Completed

NCT Number: NCT02424682

Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer

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.

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Key information

Conditions

Breast Cancer, Metastatic 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

  • 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

Treatment and study plan

No intervention

Other

No intervention administered in this study

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to 2 years

  2. Percentage of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to 2 years

  3. Percentage of Deaths

    Time frame: Up to 2 years

Secondary outcomes

  1. Percentage of Participants with Serious Adverse Events (SAEs), Who Experienced Progression of Disease

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Safety of Herceptin in Metastatic Breast Cancer

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 23, 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.

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