Oliver's mTOR Atlas Evidence Platform
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Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer (BOLERO-2)

Baselga J, Campone M, Piccart M, Burris HA, Rugo HS, Hortobagyi GN · 2012 · New England Journal of Medicine · Atlas ID BAS2012

What this study shows

A phase 3 RCT (n=724) proving mTOR matters in a common cancer. When hormone-therapy stops working in breast cancer, it's partly because mTOR switches on. Adding everolimus more than doubled progression-free survival (10.6 vs 4.1 months by central review) - leading to FDA approval. Main toxicity was stomatitis.

Abstract

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Resistance to endocrine therapy in breast cancer is associated with activation of the mammalian target of rapamycin (mTOR) intracellular signaling pathway. In early studies, the mTOR inhibitor everolimus added to endocrine therapy showed antitumor activity.

Read the full abstract on PubMed →

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 type2 - Human Clinical Trial
Model systemHumans, phase 3 RCT (n=724)
JournalNew England Journal of Medicine
Year2012
Peer reviewedYes
Record last updated2026-08-22
SourceDOI 10.1056/NEJMoa1109653 · PMID 22149876 · Free full text (PMC5705195)

Extracted findings

InterventionEverolimus + exemestane
TargetmTORC1
ModelHuman – phase 3 RCT (BOLERO-2, n=724, HR+ breast cancer)
EffectAdding everolimus to exemestane improved progression-free survival in HR+ advanced breast cancer
DoseEverolimus 10 mg once daily + exemestane vs placebo + exemestane; oral; international double-blind phase 3, 2:1 randomization (BOLERO-2).
Sample size724 women, 189 centers, 24 countries (485 everolimus-combination / 239 control); PK subgroup n=80.
Effect sizePrimary endpoint progression-free survival; adding everolimus significantly improved PFS vs exemestane alone (log-rank, stratified).
LimitationsKaplan-Meier estimates beyond week 36 to be interpreted with caution (few patients at risk, limited follow-up).

In the Atlas

Related topics

EverolimusBreast cancermTORC1

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Cite this paper

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Baselga, J., Campone, M., Piccart, M., Burris, H. A., Rugo, H. S., & Hortobagyi, G. N. (2012). Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer (BOLERO-2). New England Journal of Medicine. https://doi.org/10.1056/NEJMoa1109653

@article{BAS2012,
  author       = {Baselga, J. and Campone, M. and Piccart, M. and Burris, H. A. and Rugo, H. S. and Hortobagyi, G. N.},
  title        = {{Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer (BOLERO-2)}},
  journal      = {New England Journal of Medicine},
  year         = {2012},
  doi          = {10.1056/NEJMoa1109653},
  note         = {PMID: 22149876},
}

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 BAS2012) [Data set]. https://mtor-atlas.org/study/BAS2012/ · Dataset DOI 10.5281/zenodo.22059963

@misc{atlas_BAS2012,
  author       = {Barton, Oliver},
  title        = {{Oliver's mTOR Atlas}, record BAS2012},
  howpublished = {Data set},
  year         = {2026},
  url          = {https://mtor-atlas.org/study/BAS2012/},
  doi          = {10.5281/zenodo.22059963}
}