Overview

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.