NCT01594177 - Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions

Unilateral HER2 Positive Breast Cancer

Interventions

DRUG

Afatinib

20 mg daily for 17 weeks (first two weeks every second day).

DRUG

Trastuzumab

First cycle: loading dose 8 mg/kg (day 1 q day 22), thereafter maintenance dose for 9 cycles: 6 mg/kg (day 1 q day 22).

DRUG

Paclitaxel

80 mg/m² i.v. given weekly on day 1 q day 8 for 12 weeks.

DRUG

Epirubicin

90 mg/m² i.v. given on day 1 q day 22 for 4 cycles.

DRUG

Cyclophosphamide

600 mg/m² i.v. given on day 1 q day 22 for 4 cycles.

Trial Locations (1)

Rotkreuzklinikum München, München