Breast Cancer
Conditions
Brief summary
The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab, trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+ followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin liposomal).
Interventions
DRUGBevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
Neo-adjuvant doses (12 weeks): Bevacizumab: 15mg/Kg every 3 weeks Trastuzumab: 4 mg/Kg (First dose) - 2mg/Kg every week. Paclitaxel: 80mg/m2 every week. Adjuvant doses: Trastuzumab: 8mg/Kg(first dose)- 6mg/Kg every 3 weeks (At least 9 months) Cyclophosphamide: 600mg/m2 every 3 weeks (9 months) Doxorubicin Liposomal: 50mg/m2 every 3 weeks (3 months)
Sponsors
Hospital Universitario Madrid Sanchinarro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 medication. * 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 hemorrhage. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic response in breast and axilla | 16 weeks average |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate tumor markers as potential predictors of the pathologic response | baseline and 16 weeks average |
Countries
Spain
Outcome results
None listed