An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO) (VIRGO)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT00726661

First received: July 30, 2008

Last updated: May 23, 2016

Last verified: May 2016

History of Changes

Results First Received: April 5, 2016

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Breast Cancer

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
This study was conducted from 01 June 2008 to 31 December 2012 in the United States. A total of 1287 participants were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 1287 participants, 20 were not eligible for the study and were excluded. Of 1267 participants, 832 were observed in Chemotherapy cohort and 435 were observed in Hormonal Therapy cohort.

Reporting Groups

	Description
Chemotherapy Cohort	Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
Hormonal Therapy Cohort	Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).

Participant Flow: Overall Study

	Chemotherapy Cohort	Hormonal Therapy Cohort
STARTED	832	435
COMPLETED	18	17
NOT COMPLETED	814	418
Lost to Follow-up	36	11
Withdrawal by Subject	17	13
Trial terminated by sponsor	214	187
Death	475	159
Physician Decision	25	13
Not specified	47	35

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics was analyzed for all enrolled participants in respective individual groups (CT Cohort and HT Cohort); therefore, the data for 'mean age' for total population is not applicable for this study.

Reporting Groups

	Description
Chemotherapy Cohort	Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
Hormonal Therapy Cohort	Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
Total	Total of all reporting groups

Baseline Measures

	Chemotherapy Cohort	Hormonal Therapy Cohort	Total
Number of Participants [units: participants]	832	435	1267
Age [units: years] Mean (Standard Deviation)	57.40 (11.98)	63.99 (12.57)	59.66 (12.58)
Gender [units: participants]
Female	826	434	1260
Male	6	1	7

Outcome Measures

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1. Primary:

Progression Free Survival [ Time Frame: Approximately 4.5 years ]

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2. Secondary:

Overall Survival [ Time Frame: Approximately 4.5 years ]

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3. Secondary:

Number of Participants With Tumor Response [ Time Frame: Approximately 4.5 years ]

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4. Secondary:

Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation [ Time Frame: Approximately 4.5 years ]

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5. Secondary:

Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death [ Time Frame: Approximately 4.5 years ]

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6. Secondary:

Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy [ Time Frame: Approximately 4.5 years ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.

Results Point of Contact:

Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com

Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00726661 History of Changes
Other Study ID Numbers:	AVF4349n
Study First Received:	July 30, 2008
Results First Received:	April 5, 2016
Last Updated:	May 23, 2016
Health Authority:	United States: Institutional Review Board

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