An Investigational Randomized Study on Epirubicin Plus Cyclophospamide (EC) or Cyclophosphamide Plus Methotrexat Plus 5-fluorouracil (CMF) Versus 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)

NCT01204437 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	GBG Forschungs GmbH
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	400
Start date	2009-03
Completion	2014-01

Conditions

• Breast Cancer

Interventions

• Epirubicin, Cyclophosphamide
• Cyclophosphamide, Methotrexate, 5 FU
• Capecitabine, Nab-Paclitaxel

Primary outcomes

• To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF (EC/CMF) and nab-paclitaxel in combination with capecitabine (PX). — 4 months after Last Patient Out

Countries

Germany