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BOLERO-2 showed that adding the mTOR inhibitor everolimus to the hormone drug exemestane more than doubled the time that advanced breast cancer stayed under control after aromatase inhibitors had stopped working, the first targeted drug to overcome endocrine resistance.
BOLERO-2 randomised 724 postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer that had recurred or progressed on letrozole or anastrozole two to one to exemestane plus everolimus or exemestane plus placebo. The primary endpoint was progression-free survival.
Everolimus more than doubled median progression-free survival, at the cost of stomatitis, rash, fatigue, hyperglycaemia and pneumonitis, and overall survival was not significantly different. It was approved in the United States in July 2012 and was the standard second-line option until CDK4/6 inhibitors arrived; it remains an option after CDK4/6 inhibitor progression, particularly in tumours without a PIK3CA mutation.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
724 enrolled.
Interim analysis after 359 events; 724 randomised 2:1
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival, local investigator assessment (interim analysis)primary | Everolimus + exemestane | - | 6.9 months | 0.43 (0.35 to 0.54) | <0.001 | link |
| Placebo + exemestane | - | 2.8 months | ||||
| Progression-free survival, central assessment (interim analysis) | Everolimus + exemestane | - | 10.6 months | 0.36 (0.27 to 0.47) | <0.001 | link |
| Placebo + exemestane | - | 4.1 months | ||||
| Grade 3-4 stomatitis | Everolimus + exemestane | - | 8% | - | - | link |
| Placebo + exemestane | - | 1% |
A second publication from the BOLERO-2 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT00863655 with the most citations, so it is the natural first reading for anyone following the BOLERO-2 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Breast cancer (all types), HR-positive / HER2-negative breast cancer and the tag subtype-trials.
Shares Breast cancer (all types), HR-positive / HER2-negative breast cancer and the tag subtype-trials.
Shares Everolimus and the tag subtype-trials.
Shares Breast cancer (all types), Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Novartis and the tag subtype-trials.
Shares Breast cancer (all types) and the tag subtype-trials.
Shares Breast cancer (all types) and the tag subtype-trials.
Shares Small-molecule kinase inhibitors and the tag subtype-trials.