ot Available
- Conditions
- Early breast cancer (primary operable HER2-negative breast cancer)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022520-73-GR
- Lead Sponsor
- Hellenic Oncology Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
• 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 < 1 x ULN, ASAT (SGOT) and ALAT (SGPT) < 1.5 x ULN, Alkaline
phosphatases < 1.5 x ULN. In case of abnormal values, the liver function tests have to be repeated within 3 days before study treatment.
(c) Renal function: Creatinine < 1 x ULN
(d) Urinalysis: Urine dipstick of proteinuria < 2+.
Patients discovered to have = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24–hour urine collection and must demonstrate <1 g of protein / 24 hours.
• Signed and dated Informed Consent before the start of specific protocol procedures
• If of childbearing potential, negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>2. To evaluate the safety of this regimen<br>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<br>chemotherapy.;Timepoint(s) of evaluation of this end point: 10 months
- Secondary Outcome Measures
Name Time Method 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)<br>2. To evaluate the safety of this regimen <br>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