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ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

NCT00331097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-03-28

No results posted yet for this study

Summary

The purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant chemotherapy (weekly docetaxel).

Conditions

Interventions

DRUG

docetaxel

35 mg/m2 intravenously on days 1, 8, and 15 every 28 days

DRUG

cyclophosphamide

600 mg/m2 intravenously days 1, 8 every 28 days

DRUG

methotrexate

40 mg/m2 intravenously days 1 and 8 every 28 days

DRUG

5-fluorouracil

600 mg/m2 intravenously days 1 and 8 every 28 days

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Andrea De Matteis, M.D. · NCI Naples, Division of Medical Oncology C

  • Giuseppe D'Aiuto, M.D. · NCI Naples, Division of Surgical Oncology A

  • Francesco Perrone, M.D., Ph.D. · NCI Naples, Clinical Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2014-05-31
Completion
2014-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT00331097 on ClinicalTrials.gov