The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Metronomic chemotherapy as described below: 1. Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; 2. Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.
Metronomic chemotherapy as described below: Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.
State of Sao Paulo Cancer Institute
São Paulo, São Paulo, Brazil
Incidence of febrile neutropenia
Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%
Time frame: 18 weeks
Efficacy
Efficacy will be assessed by: 1. Tumor measurements using MRI 2. Pathologic complete response 3. Progression-free survival 4. Overall survival
Time frame: From the beginning of treatment until surgery, progression and death
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