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Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00286819
First received: February 3, 2006
Last updated: May 15, 2012
Last verified: May 2012

February 3, 2006
May 15, 2012
April 2005
Not Provided
The primary objective of this randomized phase II is to determine the relative dose intensity (RDI) of six adjuvant cycles of FEC75 and FEC90 regimens given every 14 days with pegfilgrastim (Neulasta) support in subjects with early breast cancer. [ Designated as safety issue: Yes ]
The primary objective of this randomized phase II is to determine the relative dose intensity (RDI) of six adjuvant cycles of FEC75 and FEC90 regimens given every 14 days with pegfilgrastim (Neulasta) support in subjects with early breast cancer.
Complete list of historical versions of study NCT00286819 on ClinicalTrials.gov Archive Site
  • - Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
  • -Toxicity and tolerability
  • -disease Free survival (As neither radiotherapy nor hormone therapy are specified and will be carried out according to institutional guidelines, DST has t be interpreted with caution)
  • - Quality of life
  • to determine:
  • - Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
  • -Toxicity and tolerability
  • -disease Free survival (As neither radiotherapy nor hormone therapy are specified and will be carried out according to institutional guidelines, DST has t be interpreted with caution)
  • - Quality of life
Not Provided
Not Provided
 
Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer
Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin 75 Plus Cyclophosphamide (FEC75) and Fluorouracil Plus Epirubicin 90 Plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer

This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.

Arm A: the FEC75 regimen will be given at the following doses:

Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.

Arm B: the FEC90 regimen will be given at the following doses:

Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.

All three drugs will be administered intravenously on Day 1 of each 14-day cycles.

Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.

Six cycles of adjuvant chemotherapy will be administered in both arms (A + B)

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: the FEC75 and 95 regimen

Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.

Arm B: the FEC90 regimen will be given at the following doses:

Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.

All three drugs will be administered intravenously on Day 1 of each 14-day cycles.

Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.

Six cycles of adjuvant chemotherapy will be administered in both arms (A + B

  • Experimental: the FEC75 regimen

    Arm A: the FEC75 regimen will be given at the following doses:

    Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.

    Intervention: Drug: the FEC75 and 95 regimen
  • Experimental: FEC90 regimen

    Arm B: the FEC90 regimen will be given at the following doses:

    Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.

    All three drugs will be administered intravenously on Day 1 of each 14-day cycles.

    Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.

    Intervention: Drug: the FEC75 and 95 regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2006
Not Provided

Inclusion Criteria:

  • patients with histological diagnosis of invasive breast cancer
  • Patients with early stage I, II,III breast cancer amendable for complete surgical resection.
  • Patients with any nodal status
  • Patients with ER and PR -negative tumors. In case of axillary involvement:any hormonal receptors status.
  • perfomance Status 0-1 on the ECOG Scale
  • patients indicated for adjuvant chemotherapy
  • No previous chemotherapy or radiotherapy
  • Patients have to be randomized within 8 weeks after surgery. Its recommended that patients will start chemotherapy within 1 month after surgical treatment.

Exclusion Criteria:

  • active infection
  • pregnancy/breast feeding
  • serious concomitant systemic disorders incompatible with the study
  • Second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
  • Use of any other investigational agent within 4 weeks before enrollment into the study
  • Cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Hungary,   Poland,   Slovakia
 
NCT00286819
CECOG/Breast.2.2.005
No
Central European Cooperative Oncology Group
Central European Cooperative Oncology Group
Not Provided
Principal Investigator: Thomas Brodowicz, Prof Univ. Klinik für innere Medizin I
Central European Cooperative Oncology Group
May 2012

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