Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00633464

First received: March 5, 2008

Last updated: May 9, 2012

Last verified: May 2012

History of Changes

Results First Received: March 30, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Triple Negative Locally Advanced Non-resectable Breast Cancer Metastatic Breast Cancer
Interventions:	Drug: ixabepilone Drug: ixabepilone + cetuximab

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 40 mg/m^2	ixabepilone 40 mg/m^2 every 3 weeks
Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2	cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks

Participant Flow: Overall Study

	Ixabepilone 40 mg/m^2	Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2
STARTED	40	39
Treated	40	37
COMPLETED	40 ^[1]	37 ^[2]
NOT COMPLETED	0	2
Never Treated (Not met study criteria)	0	1
Never Treated (Randomized in error)	0	1

[1]	Completed=Offstudy;major reasons:Disease progression-27,study drug toxicity-7,max clinical benefit-3
[2]	Completed=Offstudy;major reasons:Disease progression-25,study drug toxicity-4,subject request-3

Baseline Characteristics

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Reporting Groups

	Description
Ixabepilone 40 mg/m^2	ixabepilone 40 mg/m^2 every 3 weeks
Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2	cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
Total	Total of all reporting groups

Baseline Measures

	Ixabepilone 40 mg/m^2	Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2	Total
Number of Participants [units: participants]	40	39	79
Age, Customized [units: years] Median ( Full Range )	53.0 ( 29.0 to 75.0 )	50.0 ( 31.0 to 79.0 )	53.0 ( 29.0 to 79.0 )
Age, Customized [units: participants]
< 65	35	32	67
>=65	5	7	12
Gender, Customized [units: participants]
Female	40	39	79
Race/Ethnicity, Customized [units: participants]
White	39	39	78
Black/African American	1	0	1
Karnofsky Performance Status ^[1] [units: participants]
100	23	23	46
90	6	5	11
80	11	10	21
Not Reported	0	1	1
Setting of Prior Chemotherapy ^[2] [units: participants]
Adjuvant therapy	28	22	50
Neo-adjuvant therapy	20	20	40
Adjuvant and Neo-adjuvant	8	3	11

[1]	Karnofsky Performance Status classifies patients according to their functional impairment. Scores range from 0-100 units on a scale, the lower the score, the worse the survival for most serious illnesses. 100: Normal, no complaints; 90: Able to carry on normal activities; minor signs or symptoms of disease; 80: Normal activity with effort; some signs or symptoms of disease.
[2]	Participants may have received chemotherapy in more than one setting.

[1]

Karnofsky Performance Status classifies patients according to their functional impairment. Scores range from 0-100 units on a scale, the lower the score, the worse the survival for most serious illnesses.

100: Normal, no complaints; 90: Able to carry on normal activities; minor signs or symptoms of disease; 80: Normal activity with effort; some signs or symptoms of disease.

[2]

Participants may have received chemotherapy in more than one setting.

Outcome Measures

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1. Primary:

Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST]) [ Time Frame: Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks) ]

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2. Primary:

Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST) [ Time Frame: Assessed at 6 week intervals for first 12 months from randomization, thereafter every 3 months (to a maximum follow-up for tumor response of 17 months). ]

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3. Secondary:

Progression Free Survival (PFS) [ Time Frame: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 17 months) ]

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4. Secondary:

Time to Response [ Time Frame: Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until CR or PR (maximum participant time to response of 18.3 weeks.) ]

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5. Secondary:

Duration of Response [ Time Frame: From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 15.6 months) ]

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6. Secondary:

Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 [ Time Frame: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 15 weeks (range: 3-54 weeks for ixabepilone arm; 3-36 weeks for ixabepilone+cetuximab arm) ]

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7. Secondary:

Number of Participants With Hematology Abnormalities [ Time Frame: Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm) ]

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8. Secondary:

Number of Participants With Serum Chemistry Abnormalities [ Time Frame: Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm) ]

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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
ClinicalTrials.gov Identifier:	NCT00633464 History of Changes
Other Study ID Numbers:	CA163-139
Study First Received:	March 5, 2008
Results First Received:	March 30, 2012
Last Updated:	May 9, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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