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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet

• Registration Number: NCT01321775
• Lead Sponsor: Hospital Universitario Madrid Sanchinarro

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-06
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Last Update Submitted: 2011-03-23
• Study First Posted: 2011-03-24
• Last Update Posted: 2011-03-24
• Primary Completion: 2013-02
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet	Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet	-

Primary Outcome Measures

Name	Time	Method
Pathologic response in breast and axilla	16 weeks average

Secondary Outcome Measures

Name	Time	Method
To evaluate tumor markers as potential predictors of the pathologic response	baseline and 16 weeks average

Trial Locations

Locations (3)

Complejo Hospital Costa Del; 🇪🇸 Marbella, Malaga, Spain

Hospital Ramón Y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario; 🇪🇸 Madrid, Spain