EUCTR2008-003995-23-DEActive, not recruitingNot Applicable
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 - ICE II
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GBG Forschungs GmbH
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •1.Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- •2.Inadequate organ function including:
- •Leucocytes < 3,5 G/l, Platelets < 100 G/l , Creatinine or Bilirubin above normal limits, uncompensated cardiac function, severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study.
- •3.Previously or currently on of the following medical conditions:
- •pre-existing motor or sensory neuropathy of a severity ? grade 2 by NCI criteria;
- •history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent;
- •known or suspected congestive heart failure (>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 < 5 years, except curatively treated basalioma of the skin and carcinoma in situ of the cervix;
- •4.Time since axillary dissection > 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).
Investigators
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