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

NCT ID: NCT01321775

Last Updated: 2011-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-11-30

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet

Group Type: EXPERIMENTAL

Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet

Intervention Type: DRUG

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)

Interventions

Bevacizumab,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)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Madrid Sanchinarro

OTHER

Sponsor Role: lead

Responsible Party

Fundación Hospital de Madrid

Locations

Hospital Ramón Y Cajal

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario

Madrid, Madrid, Spain

Site Status: RECRUITING

Complejo Hospital Costa Del

Marbella, Malaga, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Noelia Martinez, MD

Role: primary

mjnoelia@hotmail.com

003491 336 80 00

Laura Garcia, MD

Role: primary

lauraestevez@hospitaldemadrid.com

003491 756 78 50

Diego Perez, MD

Role: primary

dipema2026@gmail.com

0034951 97 66 69

Other Identifiers

AVANTHER

Identifier Type: -

Identifier Source: org_study_id