Effect of angiogenesis inhibiting therapy in patients progressing on endocrine treatment and patients with triple negative breast cancer - a translational phase II study within theSwedish Association of Breast Oncologists SABO-2010-01

Sahlgrenska University Hospital0 sitesFebruary 25, 2011

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients with breast cancer who are oestrogen receptor positive but HER2 negative and progressing on endocrine therapy. Patients with locally advanced or recurrent triple negative breast cancer (TNBC) can also be included. Patients with TNBC will not receive endocrine therapy.
Sponsor: Sahlgrenska University Hospital
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

February 25, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Sahlgrenska University Hospital

•1\.Written informed consent approved by the Independent Ethical Board.
•2\.Female patients \>18 years with breast cancer confirmed by histology.
•3\. Relapse (local or distant) and progress on 1st, 2nd or 3rd line endocrine therapy.
•4\.Measurable or evaluable disease. Locally advanced or metastatic TNBC
•5\. ECOG PS 0\-2
•6\.Life expectancy of \>3 months
•6\.Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders.
•Haematologic function
•Absolute neutrophil count (ANC) \= 1\.5 x 109/L and
•Platelet count \= 100 x 109/L and

•1\. Previous chemotherapy for recurrent breast cancer (local or distant metastasis).
•2\. Symptoms of CNS metastases. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases.
•3\. Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment.
•4\. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
•5\. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (\>325 mg/day).
•6\. History or evidence of inherited bleeding diathesis or coagulapathy with the risk of bleeding.
•7\. Uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \>100 mmHg).
•8\. Clinically significant (i.e. active) cardiovascular disease for example CVA (\=6 months before enrolment), myocardial infarction (MI) (\=6 months before enrolment), unstable angina, CHF NYHA Class \=II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication.
•9\. Non\-healing wound, active peptic ulcer or bone fracture.
•10\. History of abdominal fistula, gastrointestinal perforation or intra\-abdominal abscess within 6 months of enrolment.