Multicentre Randomized Phase II Study of Neoadjuvant Trastuzumab Plus Docetaxel With and Without Bevacizumab and Trastuzumab Plus Docetaxel Plus Non-pegylated Liposome-encapsulated Doxorubicin (NPLD) With and Without Bevacizumab in HER2-positive Early Breast Cancer
The target study population consists of male and female pre- and postmenopausal patients
with HER2-positive, adenocarcinoma of the breast (except inflammatory breast cancer, T4d)
scheduled to receive neoadjuvant cytotoxic treatment.
Patients must have pathologically confirmed breast cancer with histologically confirmed HER2
over-expression. At screening, patients must have an adequate left ventricular ejection
fraction (LVEF); an ECOG performance status of 0 or 1; adequate liver, renal and bone marrow
function; and be free of other serious diseases that could affect protocol compliance or
interpretation of results.
Patients should not be at increased risk of GI perforation, hypertension, proteinuria, wound
healing complications, thromboembolism or hemorrhage. Patients must not have had another
primary malignancy that could affect compliance with the protocol or interpretation of
results. Patients with central nervous system (CNS) metastases are excluded. Pregnant or
lactating females are excluded. Patients with hypertension (>150 mmHG systolic or >100 mmHG
diastolic) and patients with a history of GI perforation, abdominal fistula or
intra-abdominal abscess within 6 months of study entry are excluded.
Full anticoagulation therapy at study entry is allowed as long as the patient has been on a
stable level of anticoagulants for at least 2 weeks at the time of study treatment start.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
to evaluate the cardiac toxicity of the combination trastuzumab+docetaxel+bevacizumab and trastuzumab+docetaxel+NPLD +/- bevacizumab in comparison to the standard therapy, trastuzumab+docetaxel using a composite endpoint appearing between day 1 of cycle 1 and day 28 after the day of final surgery.
between day 1 of cycle 1 and day 28 after the day of final surgery
Guenther Steger, MD
Austrian Breast & Colorectal Cancer Study Group
Austria: Federal Office for Safety in Health Care