Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin75 Plus Cyclophosphamide (FEC75) and Fluorouracil Plus Epirubicin90 Plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

[1]Female patients, age between 18-75 years.
[2]Patients with histological diagnosis of invasive breast cancer
[3]Patients with early stage I, II and III breast cancer amendable for complete surgical resection.
[4]Patients with any nodal status
[5]Patients with ER and PR-negative tumors (in case of N0 disease). In case of axillary involvement: any hormonal receptor status.
[6]Performance Status 0 or 1 on the ECOG Scale (See Attachment 1).
[7]Patients indicated for adjuvant chemotherapy
[10]Adequate organ function including the following:
Adequate bone marrow reserve: absolute neutrophil count (ANC) ³ 1.5 x 109/L, hemoglobin ³ 10.0 g/dL and platelets ³ 100 x 109/L.
Adequate renal function with serum creatinine <1.25 mg/dL.
Adequate hepatic function: ALT and AST < 1.5 ULN (Upper Limit of Normal Range), Normal Bilirubin, Alkaline phosphatase £ 2.5 ULN
Calcium £1.2 times the ULN.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[14]Active infection (at the discretion of the investigator).
[15]Pregnancy
[16]Breast-feeding.
[17]Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
[18]Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
[19]Use of any other investigational agent within 4 weeks before enrollment into the study.
[20]Concurrent administration of radiation therapy, chemotherapy, hormonal therapy, or immunotherapy (including humanized anti-HER2 antibody).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this randomized phase II study is to determine the relative dose intensity (RDI) of 6 (six) adjuvant cycles of FEC75 and FEC90 regimens given every 14 days with pegfilgrastim (Neulasta) support in subjects with early breast cancer.;Secondary Objective: ·To determine:<br>-Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events<br>-Toxicity and tolerability<br>-Disease Free Survival (DFS)<br>(As neither radiotherapy nor hormone therapy are specified and will be carried out according to institutional guidelines, DSF has to be interpreted with caution)<br>-Quality of Life (FACT-B Questionnaire)<br>;Primary end point(s): The primary objective of this randomized phase II study is to determine the relative dose intensity (RDI) of 6 (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

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