A prospective randomized Phase II study to identify predictive biomarkers and mechanisms of therapy resistance in patients with HER2-negative metastatic breast cancer (MBC) treated with the combination of bevacizumab and paclitaxel.

Karolinska University Hospital0 sitesSeptember 13, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 13, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Karolinska University Hospital

•1\.Age 18\-70 years.
•2\.Performance status ECOG 0\-2\.
•3\.Clinically and / or radiologically proven stage IV or recurrent HER2 negative breast cancer.
•4\.At least one tumor lesion accessible for biopsy. This lesion may not have been treated previously with irradiation.
•5\.Clinically and/or radiographically documented measurable disease according to RECIST v1\.1 criteria. At least one site of disease must be unidimensionally measurable as follows:
•CT\-scan, physical exam\> 10 mm}
•i.Chest X\-ray\> 20 mm}see Eisenhauer et al. for more details
•Lymph node short axis\> 15 mm}
•b.All radiology studies must be performed within 28 days prior to registration (35 days if negative).
•6\.Adequate bone\-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:

•1\.Previous systemic treatment for MBC.
•2\.Major surgery less than 28 days prior to enrollment.
•3\.Concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous\-cell carcinoma of the skin or carcinoma in situ of the cervix.
•4\.Bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
•5\.Major cardiac comorbidity.
•6\.Previous treatment with bevacizumab.
•7\.Previous allergic reaction to taxane analogs.
•8\.Ongoing pregnancy or lactation.
•9\.Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule; those conditions should be discussed with the patient before registration in the trial.