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

Piccart M, Hortobagyi GN, Campone M, Pritchard KI, Lebrun F, Ito Y, Noguchi S, Perez A, Rugo HS, Deleu I, Burris HA, …, Baselga J · 2014 · Annals of Oncology · Atlas ID PIC2014

What this study shows

This is the final overall-survival report of BOLERO-2, the phase III double-blind trial (published primary analysis: BAS2012) in which postmenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer that had progressed on a nonsteroidal aromatase inhibitor received exemestane 25 mg/day plus either everolimus 10 mg/day or placebo. The primary endpoint, progression-free survival by local investigator, remained improved: median 7.8 vs 3.2 months (P < 0.0001), a 4.6-month gain. Overall survival, a key secondary endpoint, was not significantly improved: median 31.0 vs 26.6 months, hazard ratio 0.89 (95% CI 0.73-1.10), P = 0.14, at 410 deaths. Most patients went on to further treatment after the trial (84% vs 90%), with less chemotherapy in the everolimus arm (53% vs 63%), which may have diluted any survival difference. No new safety concerns were identified. Boundary: postmenopausal women with HR+/HER2- advanced breast cancer previously treated with a nonsteroidal aromatase inhibitor; comparator was exemestane plus placebo; the survival benefit of adding mTOR inhibition was not shown.

Abstract

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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.

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At a glance

Evidence type	H Human study Marked H because it is direct evidence from a human clinical trial or human cohort; the code names the kind of study, not its quality -- a small, well-run trial is still H.
Study type	2 - Human Clinical Trial
Model system	Humans: postmenopausal women with HR+/HER2- advanced breast cancer after nonsteroidal aromatase inhibitors; phase III RCT, everolimus + exemestane vs placebo + exemestane (2:1)
Journal	Annals of Oncology
Year	2014
Peer reviewed	Yes
Record last updated	2026-10-01
Source	DOI 10.1093/annonc/mdu456 · PMID 25231953 · Free full text (PMC6267855)

Extracted findings

These fields were extracted from the paper with AI assistance and have not been checked against the source. Read them as a pointer into the paper, not as curated claims; where they disagree with the curated summary above, the curated summary stands.

Intervention	Everolimus 10 mg/day + exemestane 25 mg/day vs placebo + exemestane
Target	mTORC1 (via FKBP12)
Model	Human
Effect	PFS improved (7.8 vs 3.2 mo); overall survival not significantly improved (HR 0.89, P = 0.14)

In the Atlas

Links in the pathway map

Supports Everolimus inhibits Breast cancer

Cite this paper

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Piccart, M., Hortobagyi, G. N., Campone, M., Pritchard, K. I., Lebrun, F., Ito, Y., Noguchi, S., Perez, A., Rugo, H. S., Deleu, I., Burris, H. A., Provencher, L., Neven, P., Gnant, M., Shtivelband, M., Wu, C., Fan, J., Feng, W., Taran, T., & Baselga, J. (2014). Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†. Annals of Oncology. https://doi.org/10.1093/annonc/mdu456

@article{PIC2014,
  author       = {Piccart, M. and Hortobagyi, G. N. and Campone, M. and Pritchard, K. I. and Lebrun, F. and Ito, Y. and Noguchi, S. and Perez, A. and Rugo, H. S. and Deleu, I. and Burris, H. A. and Provencher, L. and Neven, P. and Gnant, M. and Shtivelband, M. and Wu, C. and Fan, J. and Feng, W. and Taran, T. and Baselga, J.},
  title        = {{Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†}},
  journal      = {Annals of Oncology},
  year         = {2014},
  doi          = {10.1093/annonc/mdu456},
  note         = {PMID: 25231953},
}

Cite this Atlas record

The record is the Atlas's own work — the evidence label, the extracted findings and the links. It is cited as part of the dataset, not as the paper.

Barton, O. (2026). Oliver's mTOR Atlas (record PIC2014) [Data set]. https://mtor-atlas.org/study/PIC2014/ · Dataset DOI 10.5281/zenodo.22059963

@misc{atlas_PIC2014,
  author       = {Barton, Oliver},
  title        = {{Oliver's mTOR Atlas}, record PIC2014},
  howpublished = {Data set},
  year         = {2026},
  url          = {https://mtor-atlas.org/study/PIC2014/},
  doi          = {10.5281/zenodo.22059963}
}

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