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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

Docetaxel/Capecitabine

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No