Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Breast Neoplasms

Neoplastic Cells, Circulating

Breast Diseases

Skin Diseases

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Antineoplastic Agents, Immunological

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.

trastuzumab

Michail Ignatiadis, MD

Martine Piccart, MD

Christos Sotiriou, MD

Jean-Yves Pierga, MD

Brigitte Rack, MD

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.

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

TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)

To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.

Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation

Invasive Disease Free Survival between trastuzumab and observation

Disease Free survival between trastuzumab and observation

Overall Survival between trastuzumab and observation

To evaluate in a clinical trial setting the feasibility, reliability, within patient reproducibility and variability of the assay for CTC(s)

To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS

To assess safety, especially cardiac safety, of trastuzumab in women with HER2 negative primary tumors and CTC

Spots Global Cancer Trial Database for her2 negative primary breast cancer