A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00089479

First received: August 5, 2004

Last updated: December 19, 2012

Last verified: December 2012

History of Changes

Results First Received: March 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Cancer
Interventions:	Drug: capecitabine [Xeloda] Drug: Taxotere

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
AC Then T	Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
AC Then XT	Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles

Participant Flow: Overall Study

	AC Then T	AC Then XT
STARTED	1304	1307
Received Treatment	1305 ^[1]	1283 ^[2]
COMPLETED	973 ^[3]	1018 ^[3]
NOT COMPLETED	331	289
Death	108	75
Withdrawal by Subject	86	107
Lost to Follow-up	137	107

[1]	Safety Population (includes 19 patients randomized to ACXT, who received ACT)
[2]	Safety Population (includes 5 patients randomized to ACT, who received ACXT)
[3]	total includes Completed and Alive in follow-up

Baseline Characteristics

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Reporting Groups

	Description
AC Then T	Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
AC Then XT	Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
Total	Total of all reporting groups

Baseline Measures

	AC Then T	AC Then XT	Total
Number of Participants [units: participants]	1304	1307	2611
Age [units: years] Mean ± Standard Deviation	51.2 ± 8.81	50.6 ± 9.19	50.9 ± 9.00
Gender [units: participants]
Female	1304	1307	2611
Male	0	0	0

Outcome Measures

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1. Primary:

Disease Free Survival [Number of Events] [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

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2. Primary:

Disease Free Survival [Time to Event] [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

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3. Secondary:

Overall Survival [Number of Events] [ Time Frame: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. ]

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4. Secondary:

Overall Survival [Time to Event] [ Time Frame: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. ]

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5. Secondary:

Breast Cancer Free Survival [Number of Events] [ Time Frame: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years . ]

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6. Secondary:

Breast Cancer Free Survival [Time to Event] [ Time Frame: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

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7. Secondary:

Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

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8. Secondary:

Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

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9. Secondary:

Disease Free Survival Including Any New Cancer as Event [Number of Events] [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

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10. Secondary:

Disease Free Survival Including Any New Cancer as Event [Time to Event] [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

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
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00089479 History of Changes
Other Study ID Numbers:	NO17629
Study First Received:	August 5, 2004
Results First Received:	March 31, 2011
Last Updated:	December 19, 2012
Health Authority:	United States: Food and Drug Administration

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