Status:
COMPLETED
Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast
Lead Sponsor:
GBG Forschungs GmbH
Conditions:
Breast Cancer
Eligibility:
All Genders
65+ years
Phase:
PHASE2
PHASE3
Brief Summary
Although approximately 50% of new diagnosis breast cancers are in patients above the age of 65, elderly people remain substantially under-represented in clinical trials, and therefore are under-treate...
Detailed Description
Primary Objective: Phase II: To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF (EC/CMF) and nab-paclitaxel in combination with capecitabine (PX). Secondary Objective...
Eligibility Criteria
Inclusion
- Written informed consent for all study procedures must be obtained and documented according to local regulatory requirements prior to beginning specific protocol procedures.
- Complete baseline documentation must be sent to GBG Forschungs GmbH.
- Histological confirmed unilateral or bilateral primary carcinoma of the breast.
- Female and male breast cancer patients with age at first histologically diagnosis and axilla dissection ≥ 65 years.
- Adequate surgical treatment with complete resection (R0) of the tumor and ≥ 10 axillary nodes. Sole sentinel node biopsy is allowed if the sentinel node shows no tumor involvement.
- No evidence for distant metastasis at bone scan, liver ultrasound and chest x-ray.
- Patients with stage pT3/4 or pN2/3 (≥ 4 involved lymph nodes) irrespective of additional risk factors.
- Patients with stage pT1/2 and pN0/1 (0-3 involved lymph nodes) with an increased risk according to the clinico-pathological or uPA/PAI-1 criteria.
- ECOG Performance Status \<= 2.
- Charlson Scale \<= 2.
- Estimated life expectancy of at least 5 years (irrespective of breast cancer diagnosis).
- 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.
Exclusion
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- Low risk patient according to risk assessment.
- Inadequate organ function including:
- Leucocytes \< 3,5 G/l, Platelets \< 100 G/l , Creatinine or Bilirubin above normal limits (1,25 above upper normal limit), Creatinine-Clearance below 50 ml/min, uncompensated cardiac function, severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study.
- Previously or currently one of the following medical conditions:
- pre-existing motor or sensory neuropathy of a severity \>= grade 2 by NCI-CTC 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.
- Time since axillary dissection \> 3 months.
- Locally advanced, non-operable breast cancer.
- Previous invasive breast carcinoma.
- Prior chemotherapy for any malignancy.
- Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds within the last 6 months.
- Concurrent treatment with other tumor specific experimental drugs. Participation in another clinical trial with any investigational not marketed drug.
- Concurrent treatment with virostatic agents like sorivudine or analogues 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).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01204437
Start Date
March 1 2009
End Date
January 1 2014
Last Update
February 10 2016
Active Locations (1)
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1
German Breast Group, GBG Forschungs GmbH
Neu-Isenburg, Germany, 63263