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The first phase 3 clinical trial to successfully confirm mTOR inhibition as a rational strategy after recurrence or progression following an NSAI1

The study investigated the efficacy and safety of AFINITOR (10 mg) in combination with exemestane in postmenopausal women with HR+, HER2/neu-negative advanced* breast cancer2

Study design and methodology

  • Double-blind trial designed to demonstrate superiority of AFINITOR in combination with exemestane over exemestane alone2
  • Tumor assessments/scans were conducted at baseline and every 6 weeks until disease progression4


  • Sensitivity to prior hormonal therapy
  • Presence of visceral disease

No crossover2

*Advanced breast cancer refers to locally advanced or metastatic breast cancer. 
Sensitivity to prior hormonal therapy was defined as either (1) documented clinical benefit (complete response, partial response, stable disease ≥24 weeks) to at least 1 prior hormonal therapy in advanced disease or (2) ≥24 months of adjuvant hormonal therapy prior to recurrence.
aBC, advanced breast cancer; BOLERO-2, Breast Cancer Trials of Oral Everolimus-2; CBR, clinical benefit rate; ECOG PS, Eastern Cooperative Oncology Group performance status; HR+, hormone receptor-positive; mTOR, mammalian target of rapamycin; NSAI, nonsteroidal aromatase inhibitor; ORR, objective/overall response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life; R, randomization.
1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): breast cancer. V.1.2018. Published March 20, 2018. Accessed September 21, 2018.
2. AFINITOR [summary of product characteristics]. Novartis Pharma AG; 2017.
3. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366(6):520-529.
4. Data on file. Novartis Pharma AG.