Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in HER2-positive Early Breast Cancer

Breast Cancer Clinical Trial

Official title: A Randomized, Multi-centre Cross-over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-positive Early Breast Cancer (EBC)

Status Active, not recruiting

Clinical Trial Summary

This randomized, open-label, crossover study evaluated participants' preference and healthcare professional satisfaction with trastuzumab (Herceptin) subcutaneous (sc) versus intravenous (iv) administration in participants with HER2-positive early breast cancer.

Clinical Trial Description

Participants were randomized to receive either trastuzumab 600 mg SC or trastuzumab 6 mg/kg IV every 3 weeks for Cycles 1-4, then crossover to the other treatment administration for Cycles 5-8. For the remaining up to 10 cycles, participants in Cohort 1 were administered trastuzumab 6 mg/kg IV every 3 weeks and participants in Cohort 2 were administered trastuzumab 600 mg SC every 3 weeks. Participants in Cohort 1, who had at least 2 treatment cycles remaining of their 18-cycle treatment course after the crossover period, were offered the opportunity to self-administer trastuzumab 600 mg subcutaneously using the single-injection device on Day 1 of each 3-week cycle under the direction of a trained health care practitioner. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01401166
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2011
• Completion date: December 2015