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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
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:
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 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 |