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

Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00415285

Enrollment

100

Registered

2006-12-22

Start date

2006-12-31

Completion date

Unknown

Last updated

2007-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast, Cancer, Early-Stage, Chemotherapy

Brief summary

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.

Interventions

DRUGDocetaxel

DRUGCapecitabine

DRUGDocetaxel/Capecitabine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Contacts

Primary ContactRita Johnson

404-778-7777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026