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

NCT01204437 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-02-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Epirubicin, Cyclophosphamide

4 cycles of chemotherapy with epirubicin plus cyclophosphamide (EC) on day 1 q22

DRUG

Cyclophosphamide, Methotrexate, 5 FU

6 cycles CMF on days 1 and 8 q29 Cyclophosphamide (500mg/qm), Methotrexate (40 mg/qm), 5 FU (600mg/qm)

DRUG

Capecitabine, Nab-Paclitaxel

6 cycles of weekly nab-paclitaxel 100 mg/m2 on days 1, 8, 15 q22 with a week of rest every 6 weeks in combination with capecitabine 2000 mg/m2, days 1 - 14 orally, divided into 2 daily doses every 3 weeks for 6 cycles

Sponsors & Collaborators

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Gunter von Minckwitz, Prof. · GBG Forschungs GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01204437 on ClinicalTrials.gov