Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer

Summary

The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer. The only treatment arm consists of Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks.

Timeline

Start

2013-09-30

Primary completion

2016-11-16

Completion

2016-11-16

Outcome

Outcome not reported

Stopped: “Early termination due to significant lack of relevant patient data for evaluation of objectives.”

Drugs

Indications