drugset / Trial / NCT01204437
Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |