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

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ClinicalTrials.gov Identifier: NCT00286819
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):
Central European Cooperative Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: the FEC75 and 95 regimen Phase 2

Detailed Description:

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)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.

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: 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.

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




Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. - Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
  2. -Toxicity and tolerability
  3. -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)
  4. - Quality of life


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286819


Locations
Austria
AKH, Universitätsklinik für Innere Medizin 1
Vienna, Austria, 1090
Hungary
Onkotherápiás Klinika,
Szeged, Hungary
Poland
Medical University of Gdansk, Dept. of Oncology and Radiotherapy
Gdansk, Poland, 80-211
Slovakia
Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav
Bratislava, Slovakia, 81250
Oncology Institute, Department of Radiotherapy and Onclogy
Kosice, Slovakia, 04191
Sponsors and Collaborators
Central European Cooperative Oncology Group
Investigators
Principal Investigator: Thomas Brodowicz, Prof Univ. Klinik für innere Medizin I

Responsible Party: Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00286819     History of Changes
Other Study ID Numbers: CECOG/Breast.2.2.005
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by Central European Cooperative Oncology Group:
early breast cancer,
Fluorouracil

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors