Dr. Baselga Discusses the BOLERO Breast Cancer Trials

March 5, 2012
Jose Baselga, MD, PhD

Dr. Jose Baselga from Massachusetts General Hospital Discusses the BOLERO Breast Cancer Trials

José Baselga, MD, PhD, a professor in the Department of Medicine at Harvard Medical School and chief of Hematology/Oncology at Massachusetts General Hospital, describes the 3 phase III BOLERO trials investigating everolimus (Afinitor), a mammalian target of rapamycin inhibitor, in various stages of breast cancer.

  • BOLERO-1 is still recruiting patients; it seeks to add first-line everolimus to trastuzumab (Herceptin) and paclitaxel in women with HER2-positive locally advanced or metastatic breast cancer.
  • BOLERO-2 demonstrated the efficacy of adding everolimus to exemestane in women with aromatase inhibitor resistant, hormone receptor-positive, metastatic breast cancer. It successfully extended the time to disease progression by 4.2 months (HR, 0.44).
  • BOLERO-3, which is still recruiting patients, will combine everolimus with trastuzumab and vinorelbine for post-menopausal HER2-positive breast cancer that is resistant to trastuzumab.

If the results from the BOLERO-1 and 3 trials are as positive as BOLERO-2 they will demonstrate the efficacy of everolimus in HER2-positive breast cancer, in both the first-line and refractory setting. BOLERO-2 was a second-line trial; Baselga feels a follow up study should include the first-line and adjuvant setting.

The findings of the BOLERO-2 trial go far beyond the patient population in the study. This research opens up the entire field of mTOR/PI3K-targeted therapies in multiple tumor types.