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Status unknownNCT00415285Updated Feb 13, 2007

Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer

A Phase 2 interventional study of Docetaxel and Capecitabine in Breast Neoplasms, sponsored by Georgia Center for Oncology Research & Education. Status unknown at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-02-13.

Sponsored by Georgia Center for Oncology Research & Education · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the detailed description

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.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.

Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.

02

Conditions studied

  • Breast Neoplasms

Keywords

  • Breast
  • Cancer
  • Early-Stage
  • Chemotherapy
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 100 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Georgia Center for Oncology Research & Education as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 18 years of age or older.
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants

Interventions

06

Study locations

3 of 3 sites recruiting
  • Grady Memorial Hospital
    Atlanta, Georgia 30303, United States
    • Rita Johnson · Contact · 404-778-7777
    • Ruth O'Regan · Principal investigator
    Recruiting
  • Emory Crawford Long Hospital
    Atlanta, Georgia 30308, United States
    • Rita Johnson · Contact · 404-778-7777
    • Ruth O'Regan · Principal investigator
    Recruiting
  • Winship Cancer Institute of Emory University
    Atlanta, Georgia 30322, United States
    • Rita Johnson · Contact · 404-778-7777
    • Ruth O'Regan · Principal investigator
    Recruiting
07

References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00415285
Lead sponsor
Georgia Center for Oncology Research & Education
Collaborators
Sanofi
First posted
Dec 22, 2006
Start date
Dec 2006
Last update
Feb 13, 2007

Study contacts

Rita Johnson
Contact
404-778-7777
Ruth O'Regan, MD
principal investigator · Emory University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Docetaxel · Capecitabine

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