Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer

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Roche

Status

Completed

Conditions

Breast Cancer, Metastatic Breast Cancer

Treatments

Other: No intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT02424682
ML21201

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

69 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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