Bevacizumab and Trastuzumab With Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer

• Status: Unknown status
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Madrid Sanchinarro
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Trastuzumab

Criteria

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.