CLEOPATRA Trial: Frontline Pertuzumab for HER2+ MBC

Panelists: Adam M. Brufsky, MD, PhD, University of Pittsburgh; Sara Hurvitz, MD, UCLA;
Joyce A. O'Shaughnessy, MD, US Oncology; Edith A. Perez, MD, Mayo Clinic; Hope S. Rugo, MD, UCSF;
Andrew D. Seidman, MD, MSKCC
Published Online: Monday, July 15, 2013
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Several agents are currently being explored as frontline treatments for patients with HER2-positive metastatic breast cancer. The standard of care for these patients was disrupted in 2012, when the FDA approved a frontline regimen of pertuzumab, trastuzumab, and docetaxel.

This approval was based on findings from the phase III CLEOPATRA trial that randomized 808 women to trastuzumab, docetaxel, and pertuzumab or trastuzumab, docetaxel, and placebo. The addition of pertuzumab results in a dual blockade of the HER2 extracellular domain, which resulted in an impressive prolongation in both progression-free survival and overall survival, notes Andrew D. Seidman, MD. This three-drug regimen has become the standard of care in this setting, Seidman adds.

This switch in the standard of care complicates the interpretation of ongoing trial results, such as the phase III MARIANNE trial. In this trial, T-DM1 with or without pertuzumab is being compared to trastuzumab and a taxane. As a result, a cross trial comparison of the MARIANNE and CLEOPATRA trials will likely be necessary, Seidman notes. If these approaches are similar in terms of efficacy, their side effect profiles will be the deciding factor in how they are prescribed.

If they have similar efficacy, the frontline regimen utilized may also be impacted by the costs associated with treatment, Hope S. Rugo, MD believes. Moreover, she notes, there is a lack of data to support that T-DM1 is an effective treatment for brain metastases. Along these lines, local options are available for patients with brain metastases but, overall, there are few effective options for these patients, Joyce A. O'Shaughnessy, MD, adds.

A larger questions, believes Sara Hurvitz, MD, is the impact these trials and concerns will play on the overall sequencing of agents in the second- and third-line for patients with metastatic breast cancer.

View More From This Discussion
Episode 1 Introduction and Exploration of Fulvestrant in Breast Cancer
Episode 2 Combination of Anastrozole and Fulvestrant in MBC
Episode 3 BOLERO-2 Trial: Everolimus in Metastatic Breast Cancer
Episode 4 Management of mTOR Inhibitor Side Effects in Breast Cancer
Episode 5 EMILIA Trial: T-DM1 in Metastatic Breast Cancer
Episode 6 Frontline T-DM1 in HER2+ Metastatic Breast Cancer
Episode 7 CLEOPATRA Trial: Frontline Pertuzumab for HER2+ MBC
Episode 8 MA.31 Trial: Taxane With Lapatinib or Trastuzumab
Episode 9 Treatment With Eribulin in Metastatic Breast Cancer
Episode 10 Case Study: Treating HER2-Positive MBC, Part I
Episode 11 Case Study: Treating HER2-Positive MBC, Part II
Episode 12 Paclitaxel With Pertuzumab Plus Trastuzumab in MBC
Episode 13 Case Study: Treating HR+ and HER2- Breast Cancer
Episode 14 Managing Bone Health in Metastatic Breast Cancer
Episode 15 Surgical Removal of Primary Tumors in Stage IV MBC
Episode 16 Case Study: Metastatic Triple-Negative Breast Cancer
Episode 17 Personalized Medicine in Triple-Negative Breast Cancer
Episode 18 Conclusion and Final Thoughts on Managing Breast Cancer
Expert Panelists
Dr Adam Brufsky

Adam M. Brufsky, MD, PhD

Professor of Medicine, University of Pittsburgh
Medical Director of the Women’s Cancer Center
at Magee-Womens Hospital of UPMC
and the University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania

Sara Hurvitz, MD

Assistant Professor & Director,
Hematology/Oncology Breast Cancer Program, UCLA's Jonsson Comprehensive Cancer Center, Los Angeles, California

Joyce A. O’Shaughnessy, MD

Co-Director, Breast Cancer Research
Baylor Charles A. Sammons Cancer Center
Texas Oncology, PA/US Oncology,
Dallas, Texas

Edith A. Perez, MD

Deputy Director of the Mayo Clinic Cancer Center, Director of the Breast Cancer Translational Genomics Program and the Breast Program at Mayo Clinic,
Jacksonville, Florida

Hope S. Rugo, MD

Professor of Medicine and Director of the Breast Oncology, Clinical Trials, and Education Program, University of California San Francisco Comprehensive Cancer Center, San Francisco, California

Andrew D. Seidman, MD

Professor of Medicine, Weill Cornell Cancer Center, Attending Physician at Memorial Sloan Kettering Cancer Center,
New York, New York
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