Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

This study has been completed.

Study NCT00082433 Information provided by Bristol-Myers Squibb

First Received: May 7, 2004 Last Updated: November 16, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Conditions:	Cancer Breast Cancer
Interventions:	Drug: Ixabepilone + Capecitabine Drug: Capecitabine

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
PLEASE NOTE: Completed=number of participants completing ≥18 cycles of treatment; not completed=number of subjects coming off study treatment prior to completing at least 18 cycles, with specified reasons for coming off study treatment. Participants continued to be followed for overall survival.

Reporting Groups

	Description
Ixabepilone + Capecitabine	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Capecitabine	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.

Participant Flow: Overall Study

	Ixabepilone + Capecitabine	Capecitabine
STARTED	609	612
COMPLETED	15^[1]	15^[2]
NOT COMPLETED	594	597
Adverse Event	12	17
Death	8	18
Disease Progression/Relapse	270	388
Physician Decision	50	61
Lost to Follow-up	1	2
Study Drug Toxicity	179	66
Withdrawal by Subject	55	30
Still On Treatment	2	1
Not Treated	12	11
Ineligible	2	1
Noncompliance	2	1
New primary cancer	1	0
Impending surgery	0	1

[1]	Participants who received 18 or more cycles of treatment.
[2]	Participants who received 18 or more cycles of treatment.

Baseline Characteristics

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Outcome Measures

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1. Primary:

Overall Survival (OS) [ from date of randomization until death ]

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2. Secondary:

Progression-Free Survival (PFS) [ every 6 weeks (± 3 days) from randomization while on treatment until documented progression ]

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3. Secondary:

Response Rate (RR) [ every 6 weeks (± 3 days) from randomization while on treatment until documented progression ]

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4. Secondary:

Duration of Response [ every 6 weeks (± 3 days) from randomization while on treatment until documented progression ]

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5. Secondary:

Time to Response [ every 6 weeks (± 3 days) from randomization while on treatment until documented progression ]

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6. Secondary:

Treatment-Related Safety Summary [ safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. ]

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7. Secondary:

Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) [ Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment ]

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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: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial’s primary publication.

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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-048
Study First Received:	May 7, 2004
Results First Received:	May 1, 2009
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00082433 History of Changes
Health Authority:	United States: Food and Drug Administration