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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286819
• Other study ID #: CECOG/Breast.2.2.005
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2006
• Last updated: May 15, 2012
• Start date: April 2005
• Est. completion date: September 2006

Study information

• Verified date: May 2012
• Source: Central European Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• the FEC75 and 95 regimen
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

Locations

Country	Name	City	State
Austria	AKH, Universitätsklinik für Innere Medizin 1	Vienna
Hungary	Onkotherápiás Klinika,	Szeged
Poland	Medical University of Gdansk, Dept. of Oncology and Radiotherapy	Gdansk
Slovakia	Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav	Bratislava
Slovakia	Oncology Institute, Department of Radiotherapy and Onclogy	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
Central European Cooperative Oncology Group

Countries where clinical trial is conducted

Austria,  Hungary,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			Yes
Secondary	- Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
Secondary	-Toxicity and tolerability
Secondary	-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)
Secondary	- Quality of life