EUCTR2008-003006-34-NO
Active, not recruiting
Phase 1
A multicenter, randomized, phase II clinical trial to evaluate the effect of Avastin in combination with neoadjuvant treatment regimens on the molecular and metabolic characteristics and changes in the primary tumors with reference to the obtained responses in patients with large primary HER2 negative breast cancers. - Neo-Ava
Oslo Universitetssykehus0 sites200 target enrollmentMay 21, 2008
ConditionsHER2 negative breast cancer
DrugsAvastin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HER2 negative breast cancer
- Sponsor
- Oslo Universitetssykehus
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- Platelet count \=100 x 109/L
- •\- Haemoglobin \=9 g/dL (may be transfused to maintain or exceed this level)
- •7\. Adequate liver function
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
Outcomes
Primary Outcomes
Not specified
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