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

Central European Cooperative Oncology Group50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

the FEC75 and 95 regimenDRUG

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

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

- 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

Data from ClinicalTrials.gov

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