Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

This study has been completed.

Study NCT00080301 Information provided by Bristol-Myers Squibb

First Received: March 26, 2004 Last Updated: November 16, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Conditions:	Breast Cancer Metastases
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
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Reporting Groups

	Description
Ixabepilone + Capecitabine	Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine	Capecitabine 1250 mg/m2 BID x 14 days

Participant Flow: Overall Study

	Ixabepilone + Capecitabine	Capecitabine
STARTED	375	377
Never Treated	5	10
Still on Treatment	0	1
COMPLETED	370^[1]	366^[2]
NOT COMPLETED	5	11
Randomized but Never Treated	5	10
Still on Treatment as of CSR date	0	1

[1]	Participants who are off treatment
[2]	Participants who are off treatment

Baseline Characteristics

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Outcome Measures

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1. Primary:

Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC) [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

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2. Secondary:

Overall Response Rate (ORR) Per IRRC [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

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3. Secondary:

Duration of Response Per IRRC [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

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4. Secondary:

Time to Response Per IRRC [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

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5. Secondary:

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

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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:	CA163-046
Study First Received:	March 26, 2004
Results First Received:	May 1, 2009
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00080301 History of Changes
Health Authority:	United States: Food and Drug Administration