Status:
UNKNOWN
Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer
Lead Sponsor:
Grupo Oncológico Gallego
Collaborating Sponsors:
Pivotal S.L.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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 treat...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00721747
Start Date
January 1 2008
End Date
January 1 2015
Last Update
March 16 2012
Active Locations (6)
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1
Hospital de Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08906
2
Hospital Juan Canalejo
A Coruña, Galicia, Spain, 15006
3
Centro Oncológico de Galicia
A Coruña, Galicia, Spain, 15009
4
Complejo Hospitalario de Ourense
Ourense, Galicia, Spain, 32005