drugset
drugset / Trial / NCT01363986

A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer

NCT01363986 ↗

Phase 2 Terminated 3 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on study treatment is 18 weeks.

Timeline

Start
2011-09
Primary completion
2012-06
Completion
2012-06

Outcome

Outcome not reported

Stopped (Enrollment): “Study was prematurely terminated due to difficulties experienced in recruiting patients in a reasonable timeframe.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous

Indications

breast cancer