A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT00281697

First received: January 23, 2006

Last updated: July 5, 2013

Last verified: July 2013

History of Changes

Results First Received: August 23, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Metastatic Breast Cancer
Interventions:	Drug: Bevacizumab Drug: Placebo Drug: Standard chemotherapy

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
Standard Chemotherapy + Bevacizumab	Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Standard Chemotherapy + Placebo	Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.

Participant Flow: Overall Study

	Standard Chemotherapy + Bevacizumab	Standard Chemotherapy + Placebo
STARTED	459	225
COMPLETED	58	28
NOT COMPLETED	401	197
> 60 days since last dose of study drug	4	4
Adverse Event	54	15
Death	8	3
Disease progression	279	149
Not specified	5	6
Physician's decision to withdraw	15	12
Subject/guardian's decision to withdraw	33	6
Did not receive study drug	3	2

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.
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Reporting Groups

	Description
Standard Chemotherapy + Bevacizumab	Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Standard Chemotherapy + Placebo	Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
Total	Total of all reporting groups

Baseline Measures

	Standard Chemotherapy + Bevacizumab	Standard Chemotherapy + Placebo	Total
Number of Participants [units: participants]	459	225	684
Age [units: years] Mean (Standard Deviation)	55.6 (11.0)	55.0 (11.2)	55.4 (11.1)
Gender [units: participants]
Female	457	225	682
Male	2	0	2

Outcome Measures

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1. Primary:

Progression-free Survival [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]

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2. Secondary:

Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine) [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]

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Measure Type	Secondary
Measure Title	Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)
Measure Description	Progression-free survival was defined as the time from randomization to first documented disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. Results are reported for each of the 4 standard chemotherapy cohorts used in the study.
Time Frame	Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
Safety Issue	No

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.
Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.

Reporting Groups

	Description
Standard Chemotherapy + Bevacizumab	Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Standard Chemotherapy + Placebo	Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.

Measured Values

	Standard Chemotherapy + Bevacizumab	Standard Chemotherapy + Placebo
Number of Participants Analyzed [units: participants]	459	225
Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine) [units: Months] Median (95% Confidence Interval)
Taxanes, n=201, 103	8.0 (7.2 to 9.3)	5.8 (4.2 to 7.9)
Gemcitabine, n=108, 52	6.0 (5.5 to 7.1)	5.5 (2.6 to 7.5)
Capecitabine, n=97, 47	6.9 (5.5 to 8.5)	4.1 (2.8 to 5.1)
Vinorelbine, n=53, 23	5.7 (3.5 to 7.5)	7.0 (2.7 to 8.9)

No statistical analysis provided for Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)

3. Secondary:

Overall Survival [ Time Frame: Baseline to the end of the study (up to 6 years, 7 months) ]

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4. Secondary:

One-year Survival [ Time Frame: Baseline to the end of the study (up to 6 years, 7 months) ]

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5. Secondary:

Objective Response [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]

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6. Secondary:

Duration of Objective Response [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]

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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: Medical Communications
Organization: Genentech, Inc.
phone: 800 821-8590

Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00281697 History of Changes
Other Study ID Numbers:	AVF3693g
Study First Received:	January 23, 2006
Results First Received:	August 23, 2012
Last Updated:	July 5, 2013
Health Authority:	United States: Food and Drug Administration

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