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)
Conditions
Interventions
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 fo
Sponsors
GBG Forschungs GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 restrictions due to breast cancer). 10. Charlson Scale less or equal 2. 11. Estimated life expectancy of at least 5 years (irrespective of breast cancer diagnosis). 12. The patient must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre which could be the Principal or a Co- investigator’s site. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency. 2. Inadequate organ function including: Leucocytes NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease; • Creatinine clearance less than 50 ml/min; • Another primary malignancy with an event-free survival of 3 months. 5. Locally advanced, non-operable breast cancer. 6. Previous invasive breast carcinoma. 7. Previous treatment with cytotoxic agents for any reason. 8. Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds within the last 6 months. 9. Concurrent treatment with other tumor specific experimental drugs. Participation in another clinical trial with any investigational not marketed drug 10. Concurrent treatment with virostatic agents like sorivudine or analogs like brivudine, concurrent treatment with aminoglycosides, anticoagulants: heparin, warfarin as well as acetylic acid (e.g. Aspirin®) at a dose of > 325mg/day or clopidogrel at a dose of > 75 mg/day).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF (EC/CMF) and nab-paclitaxel in combination with capecitabine (PX);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 ;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 | — |
Countries
Germany
Outcome results
None listed