Early Breast Cancer MedDRA version: 7.0 Level: PT Classification code 10006199
Conditions
Interventions
Trade Name: Epirubicin
Product Name: Epirubicin
Pharmaceutical Form: Solution for infusion
Trade Name: 5-Fluorouracil
Product Name: 5-Fluorouracil
Pharmaceutical Form: Solution for infusion
Trade Na
Sponsors
CECOG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events - Toxicity and tolerability - Disease Free Survival (DFS) (As neither radiotherapy nor hormone therapy are specified and will be carried out according to institutional guidelines, DSF has to be interpreted with caution) - Quality of Life (FACT-B Questionnaire) ;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. | — |
Countries
Hungary
Outcome results
None listed