Skip to content
Bending the Curve Trial by Trial
?

RIBBON-1

Chemotherapy with or without bevacizumab for first-line treatment of HER2-negative, locally recurrent or metastatic breast cancer

Phase 3N = 1,237NCT00262067

Population
HER2-negative locally recurrent or metastatic breast cancer, first-line
Design
Randomised 2:1, double-blind, placebo-controlled phase 3 trial. Investigators chose capecitabine, taxane-based or anthracycline-based chemotherapy before randomisation; bevacizumab or placebo 15 mg per kilogram every 3 weeks. Two independently powered cohorts (capecitabine: 615 patients; taxane or anthracycline: 622 patients).
Primary endpoint
PFS
Arms
  • Chemotherapy plus bevacizumab (experimental): Investigator-chosen chemotherapy plus bevacizumab 15 mg/kg every 3 weeks
  • Chemotherapy plus placebo (control): Investigator-chosen chemotherapy plus placebo every 3 weeks
People
Robert NJ, senior author O'Shaughnessy J
PFSHR 0.69 (95% CI 0.56–0.84)Δ median PFS+2.9 monthsPFSHR 0.64 (95% CI 0.52–0.80)Δ median PFS+1.2 months
Show the numbers
Results reported for RIBBON-1
EndpointAnalysisChemotherapy plus bevacizumabChemotherapy plus placeboEffect
PFSCapecitabine cohortprimaryRobert 2011median 8.6 monthsmedian 5.7 monthsHR 0.69 (95% CI 0.56–0.84)P<0.001Capecitabine cohort 615 patients. No statistically significant OS difference was reported in the abstract (no values given).
PFSTaxane or anthracycline cohortprimaryRobert 2011median 9.2 monthsmedian 8 monthsHR 0.64 (95% CI 0.52–0.80)P<0.001Taxane/anthracycline cohort 622 patients.
Results reported for RIBBON-1
EndpointAnalysisChemotherapy plus bevacizumabChemotherapy plus placeboEffect
PFSCapecitabine cohortprimaryRobert 2011median 8.6 monthsmedian 5.7 monthsHR 0.69 (95% CI 0.56–0.84)P<0.001Capecitabine cohort 615 patients. No statistically significant OS difference was reported in the abstract (no values given).
PFSTaxane or anthracycline cohortprimaryRobert 2011median 9.2 monthsmedian 8 monthsHR 0.64 (95% CI 0.52–0.80)P<0.001Taxane/anthracycline cohort 622 patients.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.690.56–0.84
PFS0.640.52–0.8
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Chemotherapy plus bevacizumab (experimental)
  • Chemotherapy plus placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsChemotherapy plus bevacizumabChemotherapy plus placebo
0100.0%100.0%
566.8%54.4%
1141.2%26.2%
1627.5%14.3%
2217.0%6.9%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Chemotherapy plus bevacizumab (experimental)
  • Chemotherapy plus placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsChemotherapy plus bevacizumabChemotherapy plus placebo
0100.0%100.0%
663.6%59.5%
1240.5%35.4%
1727.8%22.9%
2317.7%13.6%
Primary publication: Robert NJ, Diéras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011;29(10):1252-60. PubMedDOI

Appears in

Sources

  1. Robert NJ, Diéras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011;29(10):1252-60.

    PubMedDOI