Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Brest adenocarcinoma stages II/III Female Informed consent signed HER2 negative Age>18 years old ECOG < 1 Proper organic function regarding the following criteria: ANC > 2,0 x 109L, platelets > 100 x 109L and hemoglobin > 10g/dL (transfusion is allowed) Hepatic Function: i.Bilirubin < 1,5 x UNL ii.AST ,ALT < 2,5 x UNL iii.Alkaline phosphatase < 5 UNL iv.Patients with AST and /or ALT > 1.5 x UNL and alkaline phosphatase > 2.5 x UNL will not be selected for the study c.Renal function: creatinine < 1,25 x UNL, or creatinine clearance > 60 mL/min d.Normal Cardiac function, confirmed with FEVI >50% and electrocardiogram. Patients should be available for treatment and follow up and must be treated in investigator or co-investigator site Negative pregnancy test(performed 7 days before treatment) Exclusion Criteria: Previous treatment for breast cancer (CT, RT, IT, HT) Stages IIIb, IIIc or IV or invasive bilateral breast cancer Previous neoplasias treated with Anthracyclines or Taxanes (Paclitaxel or Docetaxel) Pregnant or breastfeeding females Neurotoxicity Grade 2 FEV≤50% or any cardiac disease in which anthracyclines are contraindicated Other severe diseases regarding investigator criteria Any neurological or psychiatric pathology Previous neoplasia different from breast cancer except: skin cancer(no melanoma) In situ cervix Carcinoma Ipsilateral in situ ductal carcinoma In situ lobular in situ carcinoma Any other carcinoma without evidence disease in last 10 years Treatment chronic with corticoids (except patients starting 6 months before inclusion with low dosages (* 20 mg methylprednisolone or equivalent) Concomitant treatment with Hormone ovarian replacement therapy Contraindication for corticoids Concomitant treatment with another investigational drugs Included in another clinical trial with any drug in 30 days before inclusion study Concomitant treatment with another anticancer therapy Male patients Hypersensibility to any study drug or components

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unique arm<br>4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv | Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide<br>* 4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine proportion of Pathological complete responses |  | At the end of the treatment, after Surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine proportion of clinical responses |  | At the end of the treatment | 
| Describe treatment safety |  | At the end of the treatment | 
| Determine proportion of conservative breast surgery |  | At the end of the study | 
| Evaluate disease free survival |  | At the end of the treatment | 
| Evaluate Overall survival |  | At the end of the treatment | 
| Evaluate gene patterns regarding prediction of treatment response |  | At the end of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer patients her2 negative pathological responses