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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic response in breast and axilla | 16 weeks average |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate tumor markers as potential predictors of the pathologic response | baseline and 16 weeks average |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ramón Y Cajal | Recruiting | Madrid | Madrid | 28034 | Spain |
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| Hospital Universitario | Recruiting | Madrid | Madrid | 28050 | Spain |
|
| Complejo Hospital Costa Del | Recruiting | Marbella | Malaga | 29600 | Spain |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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