drugset / Trial / NCT01204437

Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast

NCT01204437

Phase 2/3 Completed 400 enrolled GBG Forschungs GmbH
RandomizedParallel-groupOpen-labelTreatment

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-treated. A recent trial of the CALBG in patient's ≥ 65 years with medium risk of breast cancer demonstrated an improved disease-free and overall survival for those treated with AC or CMF compared to those treated with capecitabine alone. The primary aim of the ICE II trial is to determine the compliance and toxicity of epirubicin plus cyclophosphamide (EC) or CMF versus nab-paclitaxel plus capecitabine as adjuvant therapy in non frail elderly patients.

Timeline

Start
2009-03
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 2000 mg/m2 Oral
Comparator Cyclophosphamide Other / unclassified 500 mg/m2
Comparator Epirubicin Small molecule
Comparator Methotrexate Small molecule 40 mg/m2
Subject Paclitaxel Small molecule 100 mg/m2
Comparator fluorouracil Small molecule 600 mg/m2

Indications