Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

This study has been completed.

Study NCT00050167 Information provided by M.D. Anderson Cancer Center

First Received on November 25, 2002. Last Updated on August 25, 2011 History of Changes

Results First Received: July 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Cancer
Interventions:	Drug: Paclitaxel Drug: Docetaxel Drug: Capecitabine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period from November 20, 2002 to July 2, 2008. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Planned accrual was 930 participants, only 601 were found eligible.

Reporting Groups

	Description
Weekly Paclitaxel (WP)	Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
Docetaxel and Capecitabine (DX)	Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.

Participant Flow: Overall Study

	Weekly Paclitaxel (WP)	Docetaxel and Capecitabine (DX)
STARTED	302	301
COMPLETED	301	300
NOT COMPLETED	1	1
not eligible not invasive	1	1

Baseline Characteristics

Reporting Groups

	Description
Weekly Paclitaxel (WP)	Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
Docetaxel and Capecitabine (DX)	Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.

Baseline Measures

	Weekly Paclitaxel (WP)	Docetaxel and Capecitabine (DX)	Total
Number of Participants [units: participants]	302	301	603
Age [units: years] Median ( Full Range )	50 ( 42 to 57 )	50 ( 42 to 57 )	50 ( 42 to 57 )
Gender [units: participants]
Female	302	301	603
Male	0	0	0
Region of Enrollment [units: participants]
United States	302	301	603

Outcome Measures

1. Primary:

Percentage of Participants With Reoccurrence [ Time Frame: Median of 50 months ]

Show Outcome Measure 1

2. Secondary:

Proportion of Participants With Pathological Complete Response [ Time Frame: 7 Years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

3. Secondary:

Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes [ Time Frame: 7 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Aman Buzdar, M.D./Professor
Organization: UT MD Anderson Cancer Center
e-mail: agmadrig@mail.mdanderson.org

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00050167 History of Changes
Other Study ID Numbers:	ID01-580
Study First Received:	November 25, 2002
Results First Received:	July 7, 2011
Last Updated:	August 25, 2011
Health Authority:	United States: Food and Drug Administration