The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
1. Paclitaxel 100mg/m2 once a week for 8 weeks concomitant to trastuzumab 4mg/kg dose attack after 2mg/kg once a week for 8 weeks followed by; 2. Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, Brazil
INCIDENCE OF FEBRILE NEUTROPENIA
INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%
Time frame: 18 weeks
TUMOR SIZE
Efficacy will be assessed by: 1. Tumor measurements using MRI of the Breast 2. Pathologic complete response 3. Progression-free survival 4. Overall survival
Time frame: From the beginning of treatment until surgery, disease progression or death
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