Clinical trial NCT00286819: Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: early breast cancer,
Fluorouracil
Lead sponsor: Central European Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2006-02-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: 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:
measure: - Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
measure: -Toxicity and tolerability
measure: -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)
measure: - Quality of life
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH, Universitätsklinik für Innere Medizin 1
city: Szeged
country: Hungary
facility: Onkotherápiás Klinika,
city: Gdansk
country: Poland
facility: Medical University of Gdansk, Dept. of Oncology and Radiotherapy
city: Bratislava
country: Slovakia
facility: Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav
city: Kosice
country: Slovakia
facility: Oncology Institute, Department of Radiotherapy and Onclogy
Study officials:
affiliation: Univ. Klinik für innere Medizin I
name: Thomas Brodowicz, Prof
role: PRINCIPAL_INVESTIGATOR
References: