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. MedDRA version: 14.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Current Sponsor code: RO4876646
Other descriptive name: rhuMAb-
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Haemoglobin = 9g /dL (transfusion allowed to reach this level) Liver function Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. 11. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment. 12. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the effect of additional angiogenesis inhibiting therapy to endocrine treatment in patients with an endocrine resistant breast cancer. 2. To discover new potential predictive markers for this regimen in metastatic breast cancer. 3. To discover potential markers for monitoring treatment effect. ;Secondary Objective: Secondary endpoints: • Progression-free survival (PFS) • Identification of treatment predictive markers and markers for monitoring therapy effect by evaluation of molecular characteristics before start of therapy and modifications during treatment. • Tolerance and safety assessment. • Overall survival ;Primary end point(s): • Overall response rates (ORR); complete response (CR) and partial response (PR) by conventional radiological procedures • Clinical benefit (CR, PR and stable disease >24 weeks) | — |
Countries
Sweden
Outcome results
None listed