Taking a Look at Four Noteworthy Studies

Anita T. Shaffer @Shaffer1
Published Online: Wednesday, November 28, 2012
Dr. Debu Tripathy

Debu Tripathy, MD

The pace of discovery in breast cancer research has been brisk in the past year, leading not only to the approval of several new therapies but also to clinical trial results with the potential to change practice.

For an expert view on recent significant developments, OncologyLive sat down with Debu Tripathy, MD, coleader of the Women’s Cancer Program and a professor of Medicine at the Norris Comprehensive Cancer Center at the University of Southern California in Los Angeles.

Tripathy also is a program director for the 30th Annual Miami Breast Cancer Conference, scheduled for March 7-10, 2013, where practicing oncologists can learn about the details and nuances of research advances from leading oncology experts, and discuss ways of translating these advances into clinical practice. The conference is hosted by Physicians’ Education Resource (PER).

“Given the rapidity with which we are seeing new developments, just about every meeting has something new to report,” Tripathy noted.

Speaking in advance of the upcoming 2012 CTRC-AACR San Antonio Breast Cancer Symposium on December 4-8, Tripathy identified studies he is anticipating and discussed recently released research that he finds noteworthy. These studies include:

Everolimus Evaluated in HER2-Positive Disease

In July, the FDA approved everolimus (Afinitor) in combination with exemestane (Aromasin) for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer after progression following letrozole or anastrozole.

BOLERO-1 seeks to evaluate everolimus in combination with trastuzumab (Herceptin) in patients with HER2-positive locally advanced or metastatic breast cancer with no prior systemic therapy except endocrine therapy (Figure).

Figure. BOLERO-1 Study Design1


  • HER2+
  • Measurable disease/ bone lesions
  • Trastuzumab-naïve or prior trastuzumab and/ or chemotherapy >12 months before trial
  • Discontinue endocrine therapy before trial
  • No prior mTOR inhibitor treatment
Treatment Arms
Everolimus+paclitaxel+ trastuzumab
Stratification by
• Visceral metastases
• Prior trastuzumab
Placebo+paclitaxel+ trastuzumab
Treatment until progression or intolerable toxicity
  • Progression
  • Safety
  • Overall survival
Complete trial details are available at www.ClinicalTrials.gov, NCT00876395.
The trial, launched in September 2009, has enrolled 719 women, and the primary completion date had been forecasted for October 2012, researchers said at the American Society of Clinical Oncology annual meeting in June.1

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