Li SG, Li L. Targeted therapy in HER2-positive breast cancer. Biomed Rep. 2013;1:499-505. Abstract
Swain SM, Baselga J, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372:724-734. Abstract
Gianni L, Pienkowski T, Im YH, et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol. 2016;17:791-800. Abstract
National Comprehensive Cancer Network (NCCN) Guidelines®. Invasive breast cancer. Version 2.2016.
Giordano SH, Temin S, Kirshner JJ, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;32:2078-2099. Abstract
Baselga J, Cortés J, Kim SB, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366:109-119. Abstract
Swain SM, Baselga J, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372:724-734. Abstract
H.R. 3590-686 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ucm216146.pdf. Accessed December 14, 2016.
Rugo HS, Barve A, Waller CF, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: a randomized clinical trial. JAMA. 2016. doi: 10.1001/jama.2016.18305. [Epub ahead of print]
Burdaeva ON, Alexeev SM, Sehlepen KG, et al. Efficacy and safety of BCD-022, trastuzumab biosimilar, compared to Herceptin®: results of international multicenter randomized double blind study in patients with HER2+ mBC. In: Program and abstracts of the Congress of the European Society for Medical Oncology; October 7-11, 2016; Copenhagen, Denmark. Abstract 3854.
Kaufmann M, Hortobagyi GN, Goldhirsch A, et al. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006;24:1940-1949. Abstract
Caudle AS, Hunt KK, et al. The neoadjuvant approach in breast cancer treatment: it is not just about chemotherapy anymore. Curr Opin Obstet Gynecol. 2011;23:31-36. Abstract
Van Minckwitz G, Kaufmann M, Kuemmel S, et al. Correlation of various pathologic complete response (pCR) definitions with long-term outcome and the prognostic value of pCR in various breast cancer subtypes: results from the German neoadjuvant meta-analysis [ASCO abstract 1028]. J Clin Oncol. 2011;29(suppl).
Montagna E, Bagnardi V, Rotmensz N, et al. Pathological complete response after preoperative systemic therapy and outcome: relevance of clinical and biologic baseline features. Breast Cancer Res Treat. 2010;124:689-699. Abstract
Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25-32. Abstract
Schneeweiss A, Chia S, Hickish T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013;24(9):2278-2284.
Clinicaltrials.gov. Efficacy and safety study of ABP 980 compared with trastuzumab in subjects with HER2 positive early breast cancer (Lilac). https://clinicaltrials.gov/ct2/show/NCT01901146. Accessed December 14, 2016.
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Hurvitz SA, Martin M, Symmans WF, et al. Pathologic complete response (pCR) rates after neoadjuvant trastuzumab emtansine (TDM1 [K]) + pertuzumab (P) vs docetaxel + carboplatin + trastuzumab + P (TCHP) treatment in patients with HER2-positive (HER2+) early breast cancer (EBC) (KRISTINE) [ASCO abstract 500]. J Clin Oncol. 2016;34(suppl).
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Moderator(s)

Sara A. Hurvitz, MD, FACP

Director, Breast Cancer Clinical Research Program, Associate Professor of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California

Disclosures

Disclosure: Sara A. Hurvitz, MD, FACP, has disclosed the following relevant financial relationships:
Received grants for clinical research from: Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Cascadian, Genentech, Inc., GlaxoSmithKline, Lilly, Mediavation Inc., Merrimack, PUMA,

Dr Hurvitz does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Hurvitz does intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Hope S. Rugo, MD

Professor of Medicine, Director of Breast Oncology and Clinical Trials Education, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California

Disclosures

Disclosure: Hope S. Rugo, MD, has disclosed the following relevant financial relationships:
Served as a speaker or a member of a speakers bureau for: Genomic Health
Received grants for clinical research from: Amgen Inc., BioMarin Inc., Eisai Inc., Genentech, Inc., GlaxoSmithKline, Lilly, Macrogenics, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, OBI, Pfizer Inc., Plexxikon

Dr Rugo does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Rugo does intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor(s)

Roderick A Smith, MS

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Roderick A Smith, MS, has disclosed no relevant financial relationships.

CME Reviewer(s)

Amy H. Seung, PharmD, BCOP

Disclosures

Disclosure: Amy H. Seung, PharmD, BCOP, has disclosed no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has disclosed no relevant financial relationships.

CME / ABIM MOC

Considerations in Maximizing Outcomes in HER2-Positive Breast Cancer

Authors: Sara A. Hurvitz, MD; Hope S Rugo, MD
CME / ABIM MOC Released: 12/21/2016
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 12/21/2017, 11:59 PM EST

Start Activity

Target Audience and Goal Statement

This activity is intended for oncologists and other healthcare professionals who care for patients with breast cancer.

The goal of this activity is to increase understanding about the role of biologic therapies, and the potential role of novel biosimilars, in the care for patients with human epidermal growth factor receptor 2 (HER2)+ breast cancer across the disease spectrum.

Upon completion of this activity, learners will have:

Increased knowledge regarding the clinical trial evidence of biologics and biosimilars in the management of HER2-positive breast cancer across the continuum of disease
Greater competence related to the selection of evidence-based regimens for patients with HER2- positive breast cancer

Disclosures

Moderator(s)

Sara A. Hurvitz, MD, FACP

Director, Breast Cancer Clinical Research Program, Associate Professor of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California

Disclosures

Disclosure: Sara A. Hurvitz, MD, FACP, has disclosed the following relevant financial relationships:
Received grants for clinical research from: Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Cascadian, Genentech, Inc., GlaxoSmithKline, Lilly, Mediavation Inc., Merrimack, PUMA,

Dr Hurvitz does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Hurvitz does intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Hope S. Rugo, MD

Professor of Medicine, Director of Breast Oncology and Clinical Trials Education, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California

Disclosures

Disclosure: Hope S. Rugo, MD, has disclosed the following relevant financial relationships:
Served as a speaker or a member of a speakers bureau for: Genomic Health
Received grants for clinical research from: Amgen Inc., BioMarin Inc., Eisai Inc., Genentech, Inc., GlaxoSmithKline, Lilly, Macrogenics, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, OBI, Pfizer Inc., Plexxikon

Dr Rugo does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Rugo does intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor(s)

Roderick A Smith, MS

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Roderick A Smith, MS, has disclosed no relevant financial relationships.

CME Reviewer(s)

Amy H. Seung, PharmD, BCOP

Disclosures

Disclosure: Amy H. Seung, PharmD, BCOP, has disclosed no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has disclosed no relevant financial relationships.

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From Medscape Education Oncology

CME / ABIM MOC

Considerations in Maximizing Outcomes in HER2-Positive Breast Cancer

Authors: Sara A. Hurvitz, MD; Hope S Rugo, MDFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME / ABIM MOC Released: 12/21/2016

Valid for credit through: 12/21/2017, 11:59 PM EST

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The educational activity presented above may involve simulated case-based scenarios. The patients depicted in these scenarios are fictitious and no association with any actual patient is intended or should be inferred.

The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

References

Faculty and Disclosures

Moderator(s)

Sara A. Hurvitz, MD, FACP

Hope S. Rugo, MD

Editor(s)

Roderick A Smith, MS

CME Reviewer(s)

Amy H. Seung, PharmD, BCOP

Peer Reviewer

CME / ABIM MOC

Considerations in Maximizing Outcomes in HER2-Positive Breast Cancer

Target Audience and Goal Statement

Disclosures

Moderator(s)

Sara A. Hurvitz, MD, FACP

Hope S. Rugo, MD

Editor(s)

Roderick A Smith, MS

CME Reviewer(s)

Amy H. Seung, PharmD, BCOP

Peer Reviewer

Accreditation Statements

For Physicians

Instructions for Participation and Credit

Considerations in Maximizing Outcomes in HER2-Positive Breast Cancer