Postmenopausal women with histologically proven primary breast cancer of stages I-III scheduled for neoadjuvant endocrine treatment, N+/-, M0, HER2 negative
Conditions
Sponsors
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female Patients with histologically diagnosed hormone receptor positive (ER and/or PR positive ), HER2/neu negative (IHC 1,500/µl, platelets >1000,000/ µl and Hb =8 g/dl (iv) Normal or reduced renal function but no necessity for dialysis 2. Stage I, II or Stage III (T2-T4a-c, N0-3, M0) 3. Postmenopausal status, defined as: a) the patient is amenorrhoeic for > 12 months or b) FSH and estradiol are in postmenopausal range or c) the patient is 61 years of age or older. 4. No prior chemotherapy, radiotherapy, or endocrine therapy for invasive or non-invasive breast cancer. 5. Normal cardiac function must be confirmed by LVEF (MUGA scan or Echocardiography) within 4 weeks prior to randomization. The result must be above 50% . 6. Signed and dated informed consent 7. Willingness and ability to comply with treatment and all study related procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Concomitant conditions 1. Metastatic disease 2. Inflammatory carcinoma (T4d) 3. HER2neu positive breast cancer 4. Prior treatment for breast cancer 5. Active viral, bacterial or fungal infection 6. History of solid organ transplantation 7. CNS involvement by Breast Cancer or any evidence of spinal cord compression. Brain CT/MRI is only mandatory in case of clinical suspicion of CNS involvement by Breast Cancer 8. Prior malignancy (except adequately treated basal cell carcinoma of the skin, in situ cervical cancer, or any other cancer for which the patient has been in remission for at least 5 years) 9. Known hypersensitivity to study drug or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies) 10. Severe chronic obstructive pulmonary disease with hypoxemia 11. thrombosis unless resolved and under adequate control by anticoagulation (see 24) 12. Uncontrolled hypertension (>150mmHg and/or a diastolic >100 mmHg) or clinically significant (i.e. active) cardiovascular disease (CVA/stroke within 325 mg/day) or clopidrogel (>75 mg/day) 21. Major surgery, open biopsy or trauma within 28 days before randomization (fine-needle biopsies of breast tissue or lymph node are not considered major surgery), or the need for major surgery during the course of study treatment (adequate time delay of 6 weeks between last cycle of bevacizumab and surgery is considered in the design of the trial) 22. Current or recent (within the 30 days prior to randomization) treatment with another investigational drug or participation in another investigational therapeutic study Laboratory (determined within 7 days prior to day 1 cycle 1) 23. Inadequate liver function, defined as: - serum (total) bilirubin >1.5 x the upper limit of normal (ULN) for the institution - AST/SGOT or ALT/SGPT >2,5 x ULN - ALP >2.5 x ULN at baseline 24. Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) >1.5 or an activated partial thromboplastin time (aPTT) >1.5 x ULN within 7 days prior to first study treatment 25. Inadequate renal function (Proteinuria), d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of efficacy of neoadjuvant bevacizumab in combination with exemestane in postmenopausal patients with hormone receptor positive (ER and/or PR positive) primary breast cancer, as measured by overall clinical response rates and determined by MRT. The overall clinical response (ORR) is defined as the percentage of patients with either a complete clinical response (CR) or a partial clinical response (PR).;Secondary Objective: Assessment of angiogenic response by DCE-MRT, downstaging rate to breast-conserving surgery, complete pathological response rate;Primary end point(s): Overall Response rate (CR, PR) by MRT | — |
Countries
Austria
Outcome results
None listed