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: Primary breast cancer at non-frail, eldery male and female patients; MedDRA version: 16.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-003995-23-DE
• Lead Sponsor: GBG Forschungs GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-12
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified