A Phase 2 interventional study of trastuzumab in Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast and Circulating Tumor Cells, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 80 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 1,317 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 352 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
18 weeks
18 weeks
Drug: 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.
Also known as: endocrine therapy, anti HER2 therapy
CTC detection
To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.
Time frame: 18 weeks post randomisation
RFI (recurrence free interval)
Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation
Time frame: 2 years after LPI (last patient in)
IDFS (Invasive Disease Free Survival)
Invasive Disease Free Survival between trastuzumab and observation
Time frame: 2 years after LPI
DFS (disease free survival)
Disease Free survival between trastuzumab and observation
Time frame: 2 years after LPI
OS (overall survival)
Overall Survival between trastuzumab and observation
Time frame: 2 years after LPI
CTC essay
To evaluate in a clinical trial setting the feasibility, reliability, within patient reproducibility and variability of the assay for CTC(s)
Time frame: 2 years after LPI
CTC correlation
To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS
Time frame: 2 years after LPI
safety (cardiac)
To assess safety, especially cardiac safety, of trastuzumab in women with HER2 negative primary tumors and CTC
Time frame: 2 years after LPI
The record gives a start of Apr 2013, a primary completion of Mar 2017 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trastuzumab
European Organisation for Research and Treatment of Cancer - EORTC →