Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/Neu-Positive Metastatic Breast Cancer

This study has been completed.

Study NCT00077376 Information provided by Eastern Cooperative Oncology Group

First Received on February 10, 2004. Last Updated on March 4, 2011 History of Changes

Results First Received: March 4, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Cancer
Interventions:	Biological: trastuzumab Drug: carboplatin Drug: ixabepilone

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
The study was activated on March 19th, 2004. Accrual was suspended on December 16th, 2004 after reaching the first stage accrual goal. After a pre-planned toxicity analysis, accrual resumed on March 4th, 2005. The study was terminated on March 24th, 2006, after accruing 61 patients.

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
Trastuzumab/Ixabepilone/Carboplatin	59 treated patients; 39 HER2+ patients

Participant Flow: Overall Study

	Trastuzumab/Ixabepilone/Carboplatin
STARTED	61
COMPLETED	39
NOT COMPLETED	22
Adverse Event	8
Withdrawal by Subject	2
Death	1
Physician Decision	1
Alternative therapy	4
Complicating disease	1
Still on treatment	1
Other	4

Baseline Characteristics

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Reporting Groups

	Description
Trastuzumab/Ixabepilone/Carboplatin	59 treated patients; 39 HER2+ patients

Baseline Measures

	Trastuzumab/Ixabepilone/Carboplatin
Number of Participants [units: participants]	59
Age ^[1] [units: years] Median ( Full Range )	51 ( 24 to 81 )
Age ^[2] [units: years] Median ( Full Range )	54 ( 24 to 81 )
Gender ^[1] [units: participants]
Female	59
Male	0

[1]	All treated patients
[2]	HER2+ patients only

Outcome Measures

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1. Primary:

Objective Response for HER2+ Patients [ Time Frame: Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy ]

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2. Secondary:

Objective Response for All Treated Patients [ Time Frame: Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy ]

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3. Secondary:

Time to Disease Progression for HER2+ Patients [ Time Frame: Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy ]

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4. Secondary:

Time to Disease Progression for All Treated Patients [ Time Frame: Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy ]

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5. Secondary:

Time to Treatment Failure for HER2+ Patients [ Time Frame: Assessed every cycle ]

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6. Secondary:

Time to Treatment Failure for All Treated Patients [ Time Frame: Assessed every cycle ]

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7. Secondary:

Kaplan-Meier Estimate of Overall Survival at 3 Years for HER2+ Patients [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually ]

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8. Secondary:

Kaplan-Meier Estimate of Overall Survival at 3 Years for All Treated Patients [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually ]

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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 NOT 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.

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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012

Publications of Results:

Moulder S, Li H, Wang M, Gradishar WJ, Perez EA, Sparano JA, Pins M, Yang X, Sledge GW. A phase II trial of trastuzumab plus weekly ixabepilone and carboplatin in patients with HER2-positive metastatic breast cancer: an Eastern Cooperative Oncology Group Trial. Breast Cancer Res Treat. 2010 Feb;119(3):663-71.

Responsible Party:	Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00077376 History of Changes
Other Study ID Numbers:	CDR0000350220, E2103, U10CA023318
Study First Received:	February 10, 2004
Results First Received:	March 4, 2011
Last Updated:	March 4, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration