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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Hoffmann-La Roche |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00050167 |
Purpose
Primary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Paclitaxel Drug: Docetaxel Drug: Capecitabine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer |
| Estimated Enrollment: | 930 |
| Study Start Date: | November 2002 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Weekly Paclitaxel
|
Drug: Paclitaxel
80 mg/m^2 IV Weekly Over 1 Hour x 12 Weeks
|
|
2: Experimental
Docetaxel + Capecitabine
|
Drug: Docetaxel
75 mg/m^2 IV Over 1 Hour Once Every 3 Weeks
Drug: Capecitabine
1000 mg/m^2 PO Twice Daily x 2 Weeks
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes).
Patients with infraclavicular lymph node involvement are NOT eligible.
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M. D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Aman U. Buzdar, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Aman U. Buzdar, MD/Professor ) |
| Study ID Numbers: | ID01-580, Taxanes, Operable Breast Cancer |
| Study First Received: | November 25, 2002 |
| Last Updated: | October 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00050167 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Cancer Capecitabine Docetaxel Paclitaxel |
Taxotere Taxol Xeloda |
|
Antimetabolites Docetaxel Capecitabine Skin Diseases Paclitaxel Tubulin Modulators |
Breast Neoplasms Antimitotic Agents Antineoplastic Agents, Phytogenic Taxane Breast Diseases |
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Antimetabolites Capecitabine Antimetabolites, Antineoplastic Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Breast Neoplasms Antimitotic Agents |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |