Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Circulating Tumor Cells
• Interventions: Drug: trastuzumab

• Registration Number: NCT01548677
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Study Start: 2013-04
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1317

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Herceptin (trastuzumab)	trastuzumab	18 weeks

Primary Outcome Measures

Name	Time	Method
CTC detection	18 weeks post randomisation	To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.

Secondary Outcome Measures

Name	Time	Method
RFI (recurrence free interval)	2 years after LPI (last patient in)	Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation
IDFS (Invasive Disease Free Survival)	2 years after LPI	Invasive Disease Free Survival between trastuzumab and observation
DFS (disease free survival)	2 years after LPI	Disease Free survival between trastuzumab and observation
OS (overall survival)	2 years after LPI	Overall Survival between trastuzumab and observation
CTC essay	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	2 years after LPI	To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS
safety (cardiac)	2 years after LPI	To assess safety, especially cardiac safety, of trastuzumab in women with HER2 negative primary tumors and CTC

Trial Locations

Locations (80)

Onze Lieve Vrouw Ziekenhuis; 🇧🇪 Aalst, Belgium

Hopital Universitaire Brugmann; 🇧🇪 Brussels, Belgium

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Hopital De Jolimont; 🇧🇪 Haine St Paul, Belgium

U.Z. Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

C.H.U. Sart-Tilman; 🇧🇪 Liege, Belgium

Clinique et Maternité Sainte Elisabeth; 🇧🇪 Namur, Belgium

AZ Damiaan; 🇧🇪 Oostende, Belgium

Institut Bergonie; 🇫🇷 Bordeaux, France

Scroll for more (70 remaining)