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

NCT00286819 | Completed Phase 2

• 1 other identifier: CECOG/Breast.2.2.005
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 5

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.

Conditions

Breast Cancer

Keywords

early breast cancer,; Fluorouracil

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• - 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

Study Arms (2)

the FEC75 regimen

EXPERIMENTAL

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

FEC90 regimen

EXPERIMENTAL

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

Interventions

the FEC75 and 95 regimen DRUG

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

FEC90 regimen; the FEC75 regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central European Cooperative Oncology Group: lead

Study Sites (5)

AKH, Universitätsklinik für Innere Medizin 1

Vienna, 1090, Austria

Location

Onkotherápiás Klinika,

Szeged, Hungary

Location

Medical University of Gdansk, Dept. of Oncology and Radiotherapy

Gdansk, 80-211, Poland

Location

Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav

Bratislava, 81250, Slovakia

Location

Oncology Institute, Department of Radiotherapy and Onclogy

Košice, 04191, Slovakia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas Brodowicz, Prof

  Univ. Klinik für innere Medizin I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2006
• First Posted: February 6, 2006
• Study Start: April 1, 2005
• Study Completion: September 1, 2006
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

PL (1); HU (1); SL (2); AU (1)