# Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†

Source: https://onco.cc/key-papers/paper-bolero-2-ann-oncol-2014-update/  
OnCo record `paper-bolero-2-ann-oncol-2014-update` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Later report from the BOLERO-2 trial registered as NCT00863655, in Annals of Oncology (2014); its title describes an updated or longer-term analysis.

## Summary

Background: The BOLERO-2 study previously demonstrated that adding everolimus (EVE) to exemestane (EXE) significantly improved progression-free survival (PFS) by more than twofold in patients with hormone-receptor-positive (HR(+)), HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors (NSAIs). The overall survival (OS) analysis is presented here.

Patients and methods: BOLERO-2 is a phase III, double-blind, randomized international trial comparing EVE 10 mg/day plus EXE 25 mg/day versus placebo (PBO) + EXE 25 mg/day in postmenopausal women with HR(+) advanced breast cancer with prior exposure to NSAIs. The primary end point was PFS by local investigator assessment; OS was a key secondary end point.

Results: At the time of data cutoff (3 October 2013), 410 deaths had occurred and 13 patients remained on treatment. Median OS in patients receiving EVE + EXE was 31.0 months [95% confidence interval (CI) 28.0-34.6 months] compared with 26.6 months (95% CI 22.6-33.1 months) in patients receiving PBO + EXE (hazard ratio = 0.89; 95% CI 0.73-1.10; log-rank P = 0.14). Poststudy treatments were received by 84% of patients in the EVE + EXE arm versus 90% of patients in the PBO + EXE arm. Types of poststudy therapies were balanced across arms, except for chemotherapy (53% EVE + EXE versus 63% PBO + EXE). No new safety concerns were identified.

Conclusions: In BOLERO-2, adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point, PFS (4.6-months prolongation in median PFS; P < 0.0001). Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting.

Trial registration number: NCT00863655.

Indexed on Europe PMC as PubMed record 25231953 (DOI 10.1093/annonc/mdu456). Its abstract cites the registry id NCT00863655, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Annals of Oncology
- Year: 2014
- DOI: 10.1093/annonc/mdu456
- Authors: Piccart M, Hortobagyi GN, Campone M, et al.
- What it means: 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.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper.

## Sources

- Ann Oncol 2014: https://doi.org/10.1093/annonc/mdu456
- PubMed: https://pubmed.ncbi.nlm.nih.gov/25231953/
- Europe PMC: https://europepmc.org/article/MED/25231953
- ClinicalTrials.gov NCT00863655: https://clinicaltrials.gov/study/NCT00863655

## Connected records

- trials: [BOLERO-2](https://onco.cc/trials/bolero-2/)
- journals: [Annals of Oncology](https://onco.cc/journals/annals-of-oncology/)

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