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

ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 sites100 target enrollmentFebruary 17, 2011

ConditionsHER2-positive, adenocarcinoma of the breast (except inflammatory breast cancer, T4d)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsHerceptin Avastin Myocet

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HER2-positive, adenocarcinoma of the breast (except inflammatory breast cancer, T4d)
Sponsor: ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Enrollment: 100
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 17, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ABCSG (Austrian Breast & Colorectal Cancer Study Group)

Eligibility Criteria

Inclusion Criteria

•1\. Male or female, age \= 18 years.
•2\. Pathologically confirmed invasive primary breast adenocarcinoma (except inflammatory breast cancer, T4d) scheduled for taxan containing neoadjuvant systemic treatment with or without palpable lymph nodes.
•3\. Documented HER2 protein overexpression as determined by immunohistochemistry (IHC) 3\+ or by demonstrated HER2/c\-erbB2 gene amplification according to fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) of the primary tumor by a local laboratory.
•4\. LVEF \= 55% measured by echocardiography within 4 weeks before randomization.
•5\. ECOG Performance Status \= 1
•6\. Able and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
•7\. Written informed consent, indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•Current Treatment
•1\. Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.
•2\. Chronic daily treatment with corticosteroids (dose of \> 10 mg/day methylprednisolone equivalent) excluding inhaled steroids.
•3\. Chronic daily treatment with aspirin and aspirin analogs (\>325 mg/day) or clopidogrel (\> 75 mg / day).
•4\. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of the study treatment.
•5\. Current or recent (within 30 days prior to randomization) treatment with another investigational drug or participation in another investigational study.
•6\. Inadequate bone marrow function: absolute neutrophil count (ANC) \< 1\.5 x 109/L, platelet count \< 100 x 109/L or hemoglobin (Hb) \< 9 g/dL.
•7\. Inadequate liver function: serum (total) bilirubin \> upper limit of normal (ULN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2\.5 x ULN, AST or ALT \> 1\.5 x ULN concurrent with serum alkaline phosphatase \> 2\.5 ULN.
•8\. Inadequate renal function: Serum creatinine \> 177 µmol/L or 2\.0 mg/dL. If urine dipstick for proteinuria is \= 2\+ at baseline, the patient must undergo 24\-hour urine collection and demonstrate \= 1 g of protein/24 hr
•9\. Patients not receiving anticoagulant medication who have activated partial thromboplastin time (aPTT) \> 1\.5 x ULN within 7 days prior to Day1 of the cycle 1\.