Bevacizumab and Trastuzumab With Paclitaxel on Women With Her2+ Breast Cancer Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
- Older than 18 years
- Pre or post menopause patient with histology confirmation of breast cancer status II
or III, Her2+ confirmed by FISH technique.
- Lesion bigger than 2cm.
- life expectancy > 12 weeks.
- Normal Heart function (LVEF>55%)
- Patient should give his/her signed, written informed consent.
- Previous chemotherapy treatment.
- Previous treatment with HER2 or VEGF inhibitors.
- Pulmonary disease not controlled.
- Hypertension not controlled (systolic > 150 mmHg and/or diastolic > 100 mmHg) or
significant cardiovascular disease (CVA/cerebral hemorrhage (6 months before
inclusion), myocardial infarction (6 months before inclusion), unstable angina,
congestive cardiac disease ≥ NYHA 2, or serious cardiac arrhythmia requiring
- Antecedents of coagulopathy or clinically significant thrombosis.
- Major surgery, open biopsy or significant trauma 28 days before the inclusion in the
study or planned major surgery during the study.
- Peripheral Neuropathy > CTC 2 at inclusion.
- Altered renal function a. Creatinine > 2.0 mg/dL or 177 mmol/L. b.Proteinuria > 2+
with reactive stick(dipstick). If screening proteinuria 2+, collection of 24h urine
must show a value of proteins of 1 g/24h.
- Daily chronic treatment with corticosteroids
- Daily chronic treatment with aspirin (> 325 mg/day) o clopidogrel (> 75 mg/day)
- Antecedents or heritage evidence of bleeder diathesis or coagulopathy with risk of
- Antecedents of abdominal fistula, gastrointestinal perforation or intra-abdominal
abscess within 6 months previous to the inclusion.
- Active infection to be treated with iv antibiotics
- Serious injury not curing, peptic ulcer or bone fracture.
- Pregnant or active sexual patient not using contraceptive methods. or lactating woman
- Current or recent treatment with another IMP or participation in another clinical
trial (30 days before inclusion)
- Another primary tumor (including primary brain tumors)within 5 years to the study
inclusion, apart from in situ cervix carcinoma, skin squamous carcinoma, both if they
are appropriately treated, or skin basal cell cancer if controlled.