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
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel, Liposomal doxorubicine and Cyclophosphamide
- Conditions
- Breast Cancer
- Sponsor
- Grupo Oncológico Gallego
- Enrollment
- 83
- Locations
- 6
- Primary Endpoint
- Determine proportion of Pathological complete responses
- Last Updated
- 14 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Brest adenocarcinoma stages II/III
- •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
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)
Arms & Interventions
Unique arm
4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
Intervention: Docetaxel, Liposomal doxorubicine and Cyclophosphamide
Outcomes
Primary Outcomes
Determine proportion of Pathological complete responses
Time Frame: At the end of the treatment, after Surgery.
Secondary Outcomes
- 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)