Early breast cancer (primary operable HER2-negative breast cancer)
Conditions
Interventions
Trade Name: Avastin® cs.sol.inf. 25mg/ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
CAS Number: 216974-75-3
Current Sponsor code: RO4876646
Other descr
Sponsors
Hellenic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female patients with histologic proven, corebiopsied, invasive ductal adenocarcinoma of the breast >2 cm in size and of any N stage (clinical and/or radiological T-stage > T1, including T4d), scheduled to receive preoperative hemotherapy. • Age 18-70 years • ECOG performance-status =1 • No prior or current neoplasm except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix • No distant disease/secondary carcinoma • Normal cardiac function • Results of the following assessments at the time of inclusion must be available: - bilateral Mammography (before enrolment) - histology - grading - hormone-receptor-status - HER2 status negative (is defined as FISH/CISH negative or IHC0 or IHC1+, or IHC2+ and FISH/CISH negative) • Laboratory requirements (within 1 week before enrolment): (a) Hematology: Neutrophils = 1.5 x 109/l, Platelets = 100 x 109/l, Hemoglobin>11 g/dl (b) Hepatic function: Total bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Cytological only confirmation of diagnosis • Lobular or other non-ductal types of breast cancer • Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation • Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI-CTC AE Version 3.0 • Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy) • Prior or concurrent systemic antitumor therapy • Evidence of wound healing complications, bone fracture, ulcer or the presence of linically significant peripheral vascular disease • Clinically significant cardiac disease e.g. congestive heart failure. • Other serious illness or medical condition -uncontrolled hypertension or high risk uncontrolled arrythmias -history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent-active uncontrolled infection -unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids • Known hypersensitivity reaction to the compounds or incorporated substances. • Evidence of bleeding diathesis or coagulopathy • The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or appropriate monitoring test is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of randomization. Patients not receiving anti coagulant medication must have an INR = 1.5 an aPTT = 1.5 x ULN within 7 days of randomization. • Ongoing treatment with aspirin (> 325mg / day) or other medications known to predispose to gastrointestinal ulceration. • Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment. • Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion • Treatment with an investigational drug within 30 days prior to study entry. • Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the preliminary antitumor activity in terms of pathological complete sponses (pCR) of bevacizumab in combination with dose-dense chemotherapy.;Secondary Objective: 1. To determine the objective clinical response rates (cRR), disease-free interval (DFI), verall survival (OS), and rate of breast conservative surgery (BCS) 2. To evaluate the safety of this regimen 3. To explore the correlation of specific angiogenesis biomarkers with the clinical and pathological response of pts to the treatment;Primary end point(s): To evaluate the preliminary antitumor activity in terms of pathological complete responses (pCR) of bevacizumab in combination with dose-dense chemotherapy.;Timepoint(s) of evaluation of this end point: 10 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To determine the objective clinical response rates (cRR), disease-free interval (DFI), overall survival (OS), and rate of breast conservative surgery (BCS) 2. To evaluate the safety of this regimen 3. To explore the correlation of specific angiogenesis biomarkers with the clinical and pathological response of pts to the treatment ;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
Greece
Contacts
Public ContactIoannis Athanasakis
University Hospital of Heraklion Crete
Outcome results
None listed