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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation
- IDFS (Invasive Disease Free Survival) [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]Invasive Disease Free Survival between trastuzumab and observation
- DFS (disease free survival) [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]Disease Free survival between trastuzumab and observation
- OS (overall survival) [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]Overall Survival between trastuzumab and observation
- CTC essay [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS
- safety (cardiac) [ Time Frame: 2 years after LPI ] [ Designated as safety issue: Yes ]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:||April 2017|
|Estimated Primary Completion Date:||April 2015 (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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548677
|Contact: Mélanie Beauvois, PhD||+32 email@example.com|
|Contact: Carlo GM Messina, MD MPhil||+32 2 firstname.lastname@example.org|
|Onze Lieve Vrouw Ziekenhuis||Recruiting|
|Hopital Universitaire Brugmann||Recruiting|
|Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet||Recruiting|
|Clinique et Maternité Sainte Elisabeth||Recruiting|
|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|