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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: the FEC75 and 95 regimen

• Registration Number: NCT00286819
• Lead Sponsor: 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.

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-06
• Study Completion: 2006-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FEC90 regimen	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.
the FEC75 regimen	the FEC75 and 95 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
- Quality of life
-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)
- Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events

Trial Locations

Locations (5)

AKH, Universitätsklinik für Innere Medizin 1; 🇦🇹 Vienna, Austria

Onkotherápiás Klinika,; 🇭🇺 Szeged, Hungary

Medical University of Gdansk, Dept. of Oncology and Radiotherapy; 🇵🇱 Gdansk, Poland

Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav; 🇸🇰 Bratislava, Slovakia

Oncology Institute, Department of Radiotherapy and Onclogy; 🇸🇰 Kosice, Slovakia