Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer (TREAT-CTC)
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.
Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Circulating Tumor Cells
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)|
- CTC detection [ Time Frame: 18 weeks post randomisation ]To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.
- RFI (recurrence free interval) [ Time Frame: 2 years after LPI (last patient in) ]Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation
- IDFS (Invasive Disease Free Survival) [ Time Frame: 2 years after LPI ]Invasive Disease Free Survival between trastuzumab and observation
- DFS (disease free survival) [ Time Frame: 2 years after LPI ]Disease Free survival between trastuzumab and observation
- OS (overall survival) [ Time Frame: 2 years after LPI ]Overall Survival between trastuzumab and observation
- CTC essay [ Time Frame: 2 years after LPI ]To evaluate in a clinical trial setting the feasibility, reliability, within patient reproducibility and variability of the assay for CTC(s)
- CTC correlation [ Time Frame: 2 years after LPI ]To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS
- safety (cardiac) [ Time Frame: 2 years after LPI ]To assess safety, especially cardiac safety, of trastuzumab in women with HER2 negative primary tumors and CTC
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
No Intervention: observation
Experimental: Herceptin (trastuzumab)
8 mg/kg of loading dose IV over 90 minutes for the first cycle, followed by 6 mg/kg IV over 60 minutes every 3 weeks for the 5 subsequent cycles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548677
Show 80 Study Locations
|Principal Investigator:||Michail Ignatiadis, MD||Institut Jules Bordet, Brussels, Belgium|
|Study Chair:||Martine Piccart, MD||Institut Jules Bordet, Brussels, Belgium|
|Study Chair:||Christos Sotiriou, MD||Institut Jules Bordet, Brussels, Belgium|
|Study Chair:||Jean-Yves Pierga, MD||Institut Curie, Paris, France|
|Study Chair:||Brigitte Rack, MD||Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt, Munich, Germany|