Clinical trial NCT01321775: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hospital Universitario Madrid Sanchinarro
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Pathologic response in breast and axilla
timeFrame: 16 weeks average
Secondary outcomes:
measure: To evaluate tumor markers as potential predictors of the pathologic response
timeFrame: baseline and 16 weeks average
Other outcomes:
Locations:
city: Marbella
country: Spain
facility: Complejo Hospital Costa Del
state: Malaga
city: Madrid
country: Spain
facility: Hospital Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario
Study officials:
References: