Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Bevacizumab

Capecitabine

Vinorelbine

Taxane

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

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.

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.

The dose of bevacizumab was based on a patient's weight at baseline and remained the same throughout the study.

Placebo

Patients received one of the following four standard chemotherapies for metastatic breast cancer.

1. Taxane - Paclitaxel (Taxol) 90 mg/m\^2 IV every week for 3 weeks followed by 1 week of rest; paclitaxel (Taxol) 175 mg/m\^2 IV every 3 weeks, or paclitaxel protein-bound particles (Abraxane) 260 mg/m\^2 IV every 3 weeks; or docetaxel (Taxotere) 75-100 mg/m\^2 IV every 3 weeks.
2. Gemcitabine (Gemzar) 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle.
3. Vinorelbine (Navelbine) 30 mg/m\^2 IV every week of each 3-week cycle.
4. Capecitabine (Xeloda) 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week cycle.

Standard chemotherapy

Leo Faoro, MD

This phase III, multicenter, randomized, placebo-controlled, blinded trial is designed to evaluate the efficacy and safety of bevacizumab when combined with standard chemotherapy compared with chemotherapy alone in subjects with previously treated metastatic breast cancer.

For all Outcome Measures except Overall Survival and One-year Survival, the Time Frame was from Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years 2 months). For the Outcome Measures Overall Survival and One-year Survival, the Time Frame was from Baseline to the end of the study (up to 6 years, 7 months).

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

A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer

PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.

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.

Overall survival was defined as the time from randomization to death from any cause.

Percentage of patients who survived 1 year in the study.

A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.

Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first. Duration of objective response was only analyzed in patients who achieved an objective response.

Genentech, Inc.

Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.

Standard Chemotherapy + Bevacizumab

Standard Chemotherapy + Placebo

Total

Age Continuous

Sex: Female, Male

Medical Communications

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

Progression-free Survival

Taxanes, n=201, 103

Gemcitabine, n=108, 52

Capecitabine, n=97, 47

Vinorelbine, n=53, 23

Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)

Overall Survival

One-year Survival

Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline were included in the analysis.

Objective Response

Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline and achieved an objective response were included in the analysis.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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