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

NCT01321775 | Unknown Phase 2

• 1 other identifier: AVANTHER
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Pathologic response in breast and axilla

  16 weeks average

Secondary Outcomes (1)

• To evaluate tumor markers as potential predictors of the pathologic response

  baseline and 16 weeks average

Study Arms (1)

Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet

EXPERIMENTAL

Drug: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet

Interventions

Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet 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)

Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous chemotherapy treatment.
• Previous treatment with HER2 or VEGF inhibitors.
• Pulmonary disease not controlled.
• Antecedents of coagulopathy or clinically significant thrombosis.
• 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.
• 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

Sponsors & Collaborators

• Hospital Universitario Madrid Sanchinarro: lead

Study Sites (3)

Hospital Ramón Y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Hospital Universitario

Madrid, Madrid, 28050, Spain

RECRUITING

Complejo Hospital Costa Del

Marbella, Malaga, 29600, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: August 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 24, 2011

Record last verified: 2010-06

Locations

ES (3)