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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, 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
Overall Participants Analyzed; [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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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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Measure Type	Secondary
Measure Title	One-year Survival
Measure Description	Percentage of patients who survived 1 year in the study.
Time Frame	Baseline to the end of the study (up to 6 years, 7 months)

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
Participants Analyzed; [Units: Participants]	459	225
One-year Survival; [Units: Percentage of patients]; Number (95% Confidence Interval)	70.5; (66.3 to 74.7)	68.6; (62.5 to 74.8)

No statistical analysis provided for One-year Survival

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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