Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer

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