A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00373256

First received: September 7, 2006

Last updated: September 5, 2012

Last verified: September 2012

History of Changes

Results First Received: June 1, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Neoplasms
Interventions:	Drug: Sunitinib Drug: paclitaxel Drug: bevacizumab

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
Sunitinib + Paclitaxel	Starting sunitinib doses of 25 milligrams (mg) daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 milligrams per square meter (mg/m^2), at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
Bevacizumab + Paclitaxel	Bevacizumab 10 milligrams per kilogram (mg/kg); infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.

Description

Sunitinib + Paclitaxel

Starting sunitinib doses of 25 milligrams (mg) daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 milligrams per square meter (mg/m^2), at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.

Bevacizumab + Paclitaxel

Bevacizumab 10 milligrams per kilogram (mg/kg); infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.

Participant Flow: Overall Study

	Sunitinib + Paclitaxel	Bevacizumab + Paclitaxel
STARTED	241	247
Treated	235	236
COMPLETED	0	0
NOT COMPLETED	241	247
Adverse Event (AE)	1	5
Lost to Follow-up	2	1
Death	9	8
Objective Progression or Relapse	111	104
Refused Treatment-Reason Other Than AE	4	7
Unspecified	73	107
Protocol Violation	0	2
Study Terminated by Sponsor	41	13

Baseline Characteristics

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Reporting Groups

	Description
Sunitinib + Paclitaxel	Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
Bevacizumab + Paclitaxel	Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
Total	Total of all reporting groups

Baseline Measures

	Sunitinib + Paclitaxel	Bevacizumab + Paclitaxel	Total
Number of Participants [units: participants]	241	247	488
Age, Customized [units: Participants]
18 to 44 years	38	40	78
45 to 64 years	144	137	281
more than 65 years	59	70	129
Gender [units: Participants]
Female	240	247	487
Male	1	0	1

Outcome Measures

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1. Primary:

Progression-Free Survival (PFS) [ Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death ]

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2. Secondary:

Number of Participants With Objective Response [ Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months ]

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3. Secondary:

Duration of Response (DR) [ Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause ]

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4. Secondary:

Overall Survival (OS) [ Time Frame: From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued. ]

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5. Secondary:

Percentage of Participants Surviving at 1 and 2 Years [ Time Frame: Year 1, Year 2 ]

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6. Secondary:

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months ]

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7. Secondary:

EORTC QLQ Breast Cancer Module (BR23) [ Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months ]

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8. Secondary:

Euro Quality of Life-5 Dimension (EQ-5D) [ Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months ]

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9. Secondary:

EQ - Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months ]

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10. Secondary:

Biomarkers [ Time Frame: Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1 ]

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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: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00373256 History of Changes
Other Study ID Numbers:	A6181094
Study First Received:	September 7, 2006
Results First Received:	June 1, 2010
Last Updated:	September 5, 2012
Health Authority:	United States: Food and Drug Administration

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