A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)

This study has been terminated.

(Based on data collected, the combination appeared to be poorly tolearated.)

Sponsor:

Information provided by:

Genentech

ClinicalTrials.gov Identifier:

NCT00434356

First received: February 9, 2007

Last updated: November 17, 2009

Last verified: November 2009

History of Changes

Results First Received: September 1, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Metastatic Breast Cancer
Interventions:	Drug: bevacizumab Drug: sunitinib Drug: paclitaxel

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
Bevacizumab + Paclitaxel + Sunitinib	Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
Bevacizumab + Paclitaxel	Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest

Participant Flow: Overall Study

	Bevacizumab + Paclitaxel + Sunitinib	Bevacizumab + Paclitaxel
STARTED	23	23
COMPLETED	0	0
NOT COMPLETED	23	23

Baseline Characteristics

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Reporting Groups

	Description
Bevacizumab + Paclitaxel + Sunitinib	Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
Bevacizumab + Paclitaxel	Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
Total	Total of all reporting groups

Baseline Measures

	Bevacizumab + Paclitaxel + Sunitinib	Bevacizumab + Paclitaxel	Total
Number of Participants [units: participants]	23	23	46
Age, Customized ^[1] [units: participants]
< 18 Years	0	0	0
Between 18 and 40 Years	2	5	7
Between 41 and 64 Years	15	17	32
>= 65 Years	6	1	7
Age ^[1] [units: years] Mean ± Standard Deviation	57.3 ± 13.3	50.8 ± 11.7	54 ± 12.8
Gender ^[1] [units: participants]
Female	23	23	46
Male	0	0	0

[1]	Randomized patients

Outcome Measures

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1. Primary:

Best Response [ Time Frame: From randomization until disease progression/recurrence (by patient) ]

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2. Secondary:

Serious Adverse Events (SAEs) [ Time Frame: 30 days following the last administration of study treatment ]

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3. Secondary:

Grade ≥ 3 Adverse Events (AEs) [ Time Frame: 30 days following the last administration of study treatment ]

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4. Secondary:

Adverse Events Leading to Death [ Time Frame: 30 days following the last administration of study treatment ]

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5. Secondary:

Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction [ Time Frame: 30 days following the last administration of study treatment ]

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6. Secondary:

Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption [ Time Frame: 30 days following the last administration of study treatment ]

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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: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study.

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
Based on the early safety results from this study, further recruitment and treatment was halted. Insufficient efficacy data were available to perform all protocol-specified analyses and limited the interpretation of the analyses performed.

Results Point of Contact:

Name/Title: Medical Communications Specialist
Organization: Genentech, Inc.
phone: 800-821-8590

No publications provided

Responsible Party:	Jai Balkissoon, M.D., Study Director, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00434356 History of Changes
Other Study ID Numbers:	AVF4057g
Study First Received:	February 9, 2007
Results First Received:	September 1, 2009
Last Updated:	November 17, 2009
Health Authority:	United States: Food and Drug Administration

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