TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)
This is a randomized phase II trial for patients with HER2 negative primary BC who after
completing (neo) adjuvant chemotherapy and surgery have detectable CTC(s) in peripheral
blood (see eligibility criteria for details). Eligible patients will be randomized in 1:1
ratio to either the trastuzumab arm or the observation arm. Patients randomized to the
trastuzumab arm will receive a total of 6 intravenous (IV) administrations every 3 weeks
(loading dose 8 mg/kg IV and 5 cycles at 6 mg/kg every 3 weeks). Patients randomized to
observation arm shall be observed for 18 weeks. Left ventricular ejection fraction (LVEF)
assessment (MUGA and/or ECHO) will be done at baseline for all patients to be randomized.
The next LVEF assessments of weeks 9 and week 18 will be done only in patients randomized to
trastuzumab arm. Patient registered but with CTC negative result will not be followed-up.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.
18 weeks post randomisation
Michail Ignatiadis, MD
Institut Jules Bordet, Brussels, Belgium
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)