NCT00415285

Brief Summary

The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
Last Updated

February 13, 2007

Status Verified

February 1, 2007

First QC Date

December 20, 2006

Last Update Submit

February 12, 2007

Conditions

Breast Neoplasms

Keywords

BreastCancerEarly-StageChemotherapy

Interventions

DocetaxelDRUG
CapecitabineDRUG
Docetaxel/CapecitabineDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed breast carcinoma.
  • Early stage breast cancer (stage 1, 2, 3).
  • No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
  • years of age or older.
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

You may not qualify if:

  • Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
  • Major surgery within 28 days of study entry.
  • Evidence of CNS metastases.
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

DocetaxelCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Ruth O'Regan, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Johnson

CONTACT

404-778-7777

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 22, 2006

Study Start

December 1, 2006

Last Updated

February 13, 2007

Record last verified: 2007-02

Locations

US(3)