BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer

NCT00540800 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2016-01-14

No results posted yet for this study

Summary

Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.

Conditions

Interventions

DRUG

docetaxel

given in combination with epirubicin or capecitabine

DRUG

epirubicin

for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines

DRUG

capecitabine

for metastatic breast cancer patients previously treated with anthracyclines

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • Italy

Study Locations

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Entities

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 NCT00540800 on ClinicalTrials.gov