An investigational randomized phase II-(III) study on epirubicin plus cyclophospamide (or CMF) vs nab-paclitaxel plus capecitabine as adjuvant chemotherapy for elderly non frail patients with an increased risk for relapse of a primary carcinoma of the breast

INTERVENTION: Trade Name: Xeloda Product Name: Capecitabine Product Code: Ro 09‐1978 Pharmaceutical Form: Coated tablet Trade Name: Abraxane Product Name: Nab‐Paclitaxel Pharmaceutical Form: Powder for solution for infusion Product Name: Epirubicin Pharmaceutical Form: Powder for infusion INN or Proposed INN: EPIRUBICIN CAS Number: 56420452 Product Name: 5‐Fluorouracil Pharmaceutical Form: Solution for infusion INN or Proposed INN: FLUOROURACIL CAS Number: 51218 Product Name: Methotrexat Pharmaceutical Form: Solution for infusion INN or Proposed INN: METHOTREXATE CAS Number: 59052 Product Name: Cyclophosphamide Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180 Product Name: Cyclophosphamide Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180 CONDITION: Primary breast cancer at non‐frail, eldery male and female patients ; MedDRA version: 16.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) PRIMARY OUTCOME: Main Objective: To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF (EC/CMF) and nab‐paclitaxel in combination with capecitabine (PX) Primary end point(s): Any premature treatment discontinuation of epirubicin plus cyclophosphamide (EC) or CMF or capecitabine plus nab‐paclitaxel; Any grade II to grade IV AE specified to serious or non serious events; Secondary Objective: • To compare the disease‐free survival (DFS) and distant disease free survival (DDFS). ; • To compare the overall survival with epirubicin plus cyclophosphamide (EC) or CMF (EC/CMF) or nab‐paclitaxel in combination with capecitabine (PX). ; • To analyze the efficacy of treatments in subgroups according to hormonal receptor status.; • To assess quality of life.; • To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect.; • To compare a geriatric assessments scores (Charlson, VES 13, IADL, G8) at baseline and end of therapy; INCLUSION CRITERIA: 1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures. 2. Complete baseline documentation must be sent to GBG Forschungs GmbH. 3. Histological confirmed unilateral or bilateral primary carcinoma of the breast. 4. Female and male breast cancer patients with age at diagnosis greater or equal 65 years. 5. Adequate surgical treatment with complete resection (R0) of the tumor and 10 or more maxillary nodes. Sole sentinel node biopsy is allowed if the sentinel node shows no tumor involvement. 6. No evidence for distant metastasis at bone scan, liver ultrasound and chest x‐ray. 7. Node positive disease N2‐N3 (greater or equal 4 LN) irrespective of additional risk factors. 8. Node 0 N1 (1‐3 involved lymph nodes) with an increased risk according to the histopathological or uPA/PAI1 criteria. 9. Performance Status ECOG less or equal 2 (irrespective of restri