Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer - Full Text View

Sponsored by:	Central European Cooperative Oncology Group
Information provided by:	Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00286819

Purpose

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	Intervention	Phase
Breast Cancer	Drug: Fluorouracil, Epirubicin, Cyclophosphamide	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Fluorouracil Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Central European Cooperative Oncology Group:

Primary Outcome Measures:

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. [ Time Frame: 14 days ]

Secondary Outcome Measures:

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

Enrollment:	50
Study Start Date:	April 2005
Study Completion Date:	September 2006

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)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Study ID Numbers:	CECOG/Breast.2.2.005
Study First Received:	February 3, 2006
Last Updated:	May 10, 2007
ClinicalTrials.gov Identifier:	NCT00286819
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Central European Cooperative Oncology Group:

early breast cancer,
Fluorouracil

Study placed in the following topic categories:

Skin Diseases
Fluorouracil
Breast Neoplasms

Cyclophosphamide
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009