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Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00431080
First received: February 2, 2007
Last updated: January 18, 2008
Last verified: January 2008

February 2, 2007
January 18, 2008
August 2004
October 2007   (final data collection date for primary outcome measure)
3-year disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
3-year disease-free survival
Complete list of historical versions of study NCT00431080 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: Relapses by the time of 3-years follow up ] [ Designated as safety issue: No ]
  • Τoxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Quality of life between the two treatment arms [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
  • Overall survival
  • Ρecurrence rate
  • Τoxicity profile
  • Quality of life between the two treatment arms
Not Provided
Not Provided
 
Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer
A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer

This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
    Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
    Other Name: Taxotere
  • Drug: Paclitaxel
    Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles
    Other Name: Taxol
  • Drug: Epirubicin
    Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
    Other Name: Farmorubicin
  • Drug: Cyclophosphamide
    Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
    Other Name: Endoxan
  • Drug: 5-fluoruracil
    5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
    Other Name: 5-FU
  • Drug: Granulocyte-colony stimulating growth factor
    rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
    Other Names:
    • Granocyte
    • Neulasta
  • Experimental: 1
    FEC -> TXT
    Interventions:
    • Drug: Docetaxel
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: 5-fluoruracil
    • Drug: Granulocyte-colony stimulating growth factor
  • Experimental: 2
    FEC -> TXL
    Interventions:
    • Drug: Paclitaxel
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: 5-fluoruracil
    • Drug: Granulocyte-colony stimulating growth factor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
478
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
  • Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
  • Tumor involvement of at least one axillary lymph node
  • Absence of any clinical or radiological evidence of local or metastatic disease
  • Premenopausal or postmenopausal women aged 18-75 years old
  • Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
  • Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
  • Adequate cardiac function (LVEF>50%)
  • Written informed consent

Exclusion Criteria:

  • Positive pregnancy test.
  • Psychiatric illness or social situation that would preclude study compliance.
  • Other concurrent uncontrolled illness.
  • Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
  • Previous history of other invasive malignancy other than non-melanomatous skin cancer.
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00431080
CT/04.22
Not Provided
D.Mavrudis, Hellenic Oncology Research Group
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
Hellenic Oncology Research Group
January 2008

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