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Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

NCT00209092 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2015-03-27

Study results available
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Summary

The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Conditions

Interventions

DRUG

Docetaxel

Sequential Therapy: Docetaxel will be given at 100 mg/m\^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles. Concurrent Therapy: Docetaxel will be given at 50 mg/m\^2 IV Day 1.

DRUG

Capecitabine

Sequential Therapy: administration of capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Sponsors & Collaborators

  • Georgia Center for Oncology Research & Education

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Amelia Zelnak, MD · Emory University Winship Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-07-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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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 NCT00209092 on ClinicalTrials.gov