Trial | NCT00721747  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    83
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 Started
Jan 31
2008
Primary Completion
Jan 31
2011
Study Completion
Jan 31
2015
Anticipated
Last Update
Mar 16
2012
Estimate

Drug Docetaxel, Liposomal doxorubicine and Cyclophosphamide

4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv

Unique arm Experimental

4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv

Criteria 

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
No Results Posted