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

Sponsor
Hospital Universitario Madrid Sanchinarro
Study ID
NCT01321775
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)

Study Details

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).

Key Dates

First listed
Mar 24, 2011
Start date
Aug 31, 2009
Status verified
Jun 2010
Primary completion
Feb 28, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet

Primary Outcome Measure

Pathologic response in breast and axilla [ Time Frame: 16 weeks average ]

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