Bringing the Oncology Community Together

Taking a Look at Four Noteworthy Studies

Anita T. Shaffer
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, 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

Page: 123Next Page (2) >>
Related Articles
Phase III Clinical Trials in HER2-Positive Breast Cancer
Expert panelists explore several large clinical trials examining therapies for patients with HER2-positive breast cancer that are currently ongoing or have recently completed.
Experts Support Broader Pertuzumab Use in HER2-Positive Breast Cancer
The recent approval of pertuzumab as part of a combination neoadjuvant treatment for patients with early-stage breast cancer has paved the way for wider use of the regimen in preoperative settings.
New ASCO Guideline Expands Recommendation for SLN Biopsy Use in Early Stage Breast Cancer
An updated guideline from ASCO regarding the use of sentinel lymph node (SLN) biopsy in early stage breast cancer supports the use of the procedure over axillary lymph node dissection (ALND) in a larger group of patients than previously recommended.
I-SPY 2 Designer Describes Program’s Many Innovations
Donald A. Berry, PhD, is a leader in the development of innovative statistical methodology for the improvement of clinical trial design and analysis, especially the Bayesian methods used in the I-SPY program.
Most Popular Right Now
More Reading
External Resources

American Journal of Managed Care
Pharmacy Times
Physicians' Education Resource
Physician's Money Digest
Specialty Pharmacy Times
OncLive Resources

OncLive TV
Oncology Nurses
Web Exclusives

About Us
Advisory Board
Contact Us
Forgot Password
Privacy Policy
Terms & Conditions
Intellisphere, LLC
666 Plainsboro Road
Building 300
Plainsboro, NJ 08536
P: 609-716-7777
F: 609-716-4747

Copyright OncLive 2006-2014
Intellisphere, LLC. All Rights Reserved.