The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.
Phase II, open, not randomized clinical trial, to evaluate the sequential Taxotere®, followed by Myocet® and Cyclophosphamide first line treatment in her2 negative breast cancer patients. The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
Hospital de Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Juan Canalejo
A Coruña, Galicia, Spain
Centro Oncológico de Galicia
A Coruña, Galicia, Spain
Complejo Hospitalario de Ourense
Ourense, Galicia, Spain
Determine proportion of Pathological complete responses
Time frame: At the end of the treatment, after Surgery.
Determine proportion of clinical responses
Time frame: At the end of the treatment
Describe treatment safety
Time frame: At the end of the treatment
Determine proportion of conservative breast surgery
Time frame: At the end of the study
Evaluate disease free survival
Time frame: At the end of the treatment
Evaluate Overall survival
Time frame: At the end of the treatment
Evaluate gene patterns regarding prediction of treatment response
Time frame: At the end of the treatment
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Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Xeral Cies
Vigo, Galicia, Spain