HER2 negative breast cancer
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
Concentration unit: mg/ml milli
Sponsors
Oslo Universitetssykehus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent (informed consent document to be approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure 2. Female or male age =18 years 3. Able to comply with the protocol 4. Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, more than 2.0 cm in size 5. ECOG/WHO performance status = 2 6. Adequate haematological function - Absolute neutrophil count (ANC) =1.0 x 109/L AND - Platelet count =100 x 109/L AND - Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level) 7. Adequate liver function - Total bilirubin =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic disease). 2. Previous treatment for localized breast cancer (chemotherapy, radiotherapy or hormonal treatment) less than 24 months from the diagnosis of the present breast cancer. 3. Other earlier or concomitant carcinoma, exept for BCC, in situ cervix cancer or breast cancer 4. 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 5. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion 6. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (>325 mg/day) 7. Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed 8. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding 9. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) 10. Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (=6 months before enrolment), unstable angina, congestive heart failure (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 11. Non-healing wound, active peptic ulcer or bone fracture 12. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment 13. Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of bevacizumab. 14. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment 15. Known hypersensitivity to bevacizumab and any of its excipients, and any of the chemotherapies 16. 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: The primary objective of the study is to determine the molecular, metabolic and dynamic MRI characteristics and changes of the primary tumors with reference to the obtained response (pathological complete response and clinical objective response) by treatment with chemotherapy +/- bevacizumab or endocrine therapy +/- bevacizumab as preoperative (neoadjuvant) treatment in HER2-negative patients.;Secondary Objective: Evaluation of the presence, characteristics and change in numbers of disseminated tumor cells (DTC) in bone marrow and circulating tumor cells (CTC) in peripheral blood before treatment start, at the end of neoadjuvant treatment (at surgery) and during follow up, according to bevacizumab treatment Evaluation of the presence and number of circulating endothelial cells (CEC) in peripheral blood before treatment start, at the end of neoadjuvant treatment (at surgery) and during follow up, according to bevacizumab treatment. SNP - analyses ;Primary end point(s): The molecular, metabolic and dynamic MRI determinants of pathological complete responses (pCR) in the breast and in the lymph nodes | — |
Countries
Norway
Contacts
Public ContactOlav Engebråten
Oslo Universitetssykehus
Outcome results
None listed