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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pivotal S.L.
Information provided by (Responsible Party):
Grupo Oncológico Gallego
ClinicalTrials.gov Identifier:
NCT00721747
First received: July 23, 2008
Last updated: March 15, 2012
Last verified: March 2012
History of Changes

July 23, 2008
March 15, 2012
January 2008
January 2011   (final data collection date for primary outcome measure)
Determine proportion of Pathological complete responses [ Time Frame: At the end of the treatment, after Surgery. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721747 on ClinicalTrials.gov Archive Site
  • Determine proportion of clinical responses [ Time Frame: At the end of the treatment ] [ Designated as safety issue: No ]
  • Describe treatment safety [ Time Frame: At the end of the treatment ] [ Designated as safety issue: Yes ]
  • Determine proportion of conservative breast surgery [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Evaluate disease free survival [ Time Frame: At the end of the treatment ] [ Designated as safety issue: No ]
  • Evaluate Overall survival [ Time Frame: At the end of the treatment ] [ Designated as safety issue: No ]
  • Evaluate gene patterns regarding prediction of treatment response [ Time Frame: At the end of the treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
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
Experimental: 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: Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
83
January 2015
January 2011   (final data collection date for primary outcome measure)

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:

    1. ANC > 2,0 x 109L, platelets > 100 x 109L and hemoglobin > 10g/dL (transfusion is allowed)
    2. 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:

    1. skin cancer(no melanoma)
    2. In situ cervix Carcinoma
    3. Ipsilateral in situ ductal carcinoma
    4. In situ lobular in situ carcinoma
    5. 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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00721747
GOG/2007-01, 2007-005173-56
Yes
Grupo Oncológico Gallego
Grupo Oncológico Gallego
Pivotal S.L.
Principal Investigator: Jesús García Mata, MD Grupo Oncológico Gallego
Grupo Oncológico Gallego
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP