Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer — ChangHER-SC  

Breast Cancer Clinical Trial

Official title: Phase III Trial to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous (IV) Administration in HER2 Positive Advanced Breast Cancer Who Have Received IV Trastuzumab at Least 4 Months and Without Disease Progression

Status Completed

Clinical Trial Summary

GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within the SC by the administration through the vial or device self-administration in patients with disseminated breast cancer HER2.

Clinical Trial Description

Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a syringe and 2 with the injection device). Following administration of these four cycles, the patient will decide whether or not to continue with the subcutaneous formulation of trastuzumab every 3 weeks until progression (out of the study). Since the randomization in the study until the start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous trastuzumab as usual.

Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs intravenous trastuzumab.

This principal primary objective will be analyzed with the answers to questionnaire of experiences and preferences of the patients (Principal endpoint) The duration of the study has been estimated after 34 months. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01875367
• Study type: Interventional
• Source: Spanish Breast Cancer Research Group
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2013
• Completion date: April 30, 2018