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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2006

Last Updated Date

May 15, 2012

Start Date ^ICMJE

April 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00286819 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: the FEC75 and 95 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.

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Hungary, Poland, Slovakia

Administrative Information

NCT Number ^ICMJE

NCT00286819

Other Study ID Numbers ^ICMJE

CECOG/Breast.2.2.005

Has Data Monitoring Committee

Responsible Party

Central European Cooperative Oncology Group

Study Sponsor ^ICMJE

Central European Cooperative Oncology Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas Brodowicz, Prof

Univ. Klinik für innere Medizin I

Information Provided By

Central European Cooperative Oncology Group

Verification Date

May 2012

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

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