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

Roche

Status: Completed

Conditions: Breast Cancer, Early Breast Cancer

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02443467

ML20397

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

211 participants in 1 patient group

HER2-positive early breast cancer

Description:

Human Epidermal Growth Factor Receptor 2 (HER2)-positive early breast cancer treated with loading dose of Herceptin (trastuzumab) administered as 6 mg/kg followed by once in 3 weeks administration at 4 mg/kg up to 12 months of treatment

Treatment:

Other: No intervention