Breast Cancer CME ACCREDITED Watch Time: 38 mins

touchEXPERT OPINIONS Evolving treatment options beyond progression for HER2-positive advanced breast cancer

Stay up-to-date with the latest data for novel targeted therapies being developed to overcome resistance to standard of care HER2-targeted therapies in patients with HER2-positive advanced breast cancer.

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Dr Eva Ciruelos
University Hospital 12 de Octubre, HM Hospitals, Madrid, Spain
Why novel treatment options are needed for HER2-positive advanced breast cancer

Dr Eva Ciruelos examines why new treatments are required to address unmet needs in patients with HER2-positive advanced breast cancer and describes how novel therapies act to target resistance to anti-HER2 therapies.

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Interview Questions

In this interview, Dr Eva Ciruelos answers the following questions:

  • What is the clinical rationale for the use of anti-HER2 therapies beyond progression?
  • How does resistance to current anti-HER2 therapies develop?
  • What is the rationale for the development of antibody-drug conjugates for HER2-positive breast cancer?
  • How are novel tyrosine kinase inhibitors being used to target HER2-positive breast cancer?
  • How might novel monoclonal antibodies enhance antibody-dependent cellular cytotoxicity in HER2-positive breast cancer?
About Dr Eva Ciruelos

Eva M Ciruelos, MD, PhD, is a medical oncologist and coordinator of the Multidisciplinary Breast Cancer Units at the University Hospital 12 de Octubre and HM Hospitals in Madrid, Spain. In addition, she has been an Associate Professor in the Department of Medicine at the Complutense University of Madrid since 2008. read more

Dr Ciruelos is the principal investigator of several clinical trials and research projects in breast cancer and is on the steering committee for several registration clinical trials. She is the current vice president of the Solid Tumor Intensification (SOLTI) Group and is also a member of the scientific committee of the Breast International Group (BIG) and the St Gallen Conference Panel. Dr Ciruelos is an author and reviewer of oncology practice guidelines at both a national (Spanish Society of Medical Oncology) and international level.

She has contributed to oncology textbook chapters, and is an author or co-author of articles with a focus on breast cancer research. She also plays an active role in medical education events for breast cancer.

Disclosures:
Consultant/advisory board fees and congress assistance from Eli Lilly, Novartis, Pfizer and Roche.

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Prof. Rupert Bartsch
Medical University of Vienna, Austria
Evaluating novel later-line targeted therapies for HER2-positive advanced breast cancer

Prof. Rupert Bartsch reviews the latest efficacy and safety data for later-line novel HER2-targeted therapies in patients with HER2-positive advanced breast cancer.

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Interview Questions

In this interview, Prof. Rupert Bartsch answers the following questions:

  • Which key clinical trials investigating novel anti-HER2 therapies are of interest?
  • What were the main outcomes from the HER2CLIMB study of the tucatinib combination?
  • What do the results from the DESTINY-Breast01 study tell us about the effectiveness of trastuzumab deruxtecan?
  • What were the main outcomes of the SOPHIA trial in patients treated with margetuximab?
  • What do these trials add to outcomes observed in clinical trials with other targeted agents such as neratinib?
About Prof. Rupert Bartsch

Rupert Bartsch, MD, is Associate Professor of Medicine at the Medical University of Vienna, Austria, and currently serves as Director of the Breast Cancer Program at the Department of Oncology. Prior to this, he was Head of the Breast Centre at the Elisabethinen Hospital in Linz, Austria, and from late 2017 until March 2018, he was based at the German Breast Group in Neu-Isenburg, Germany. read more

Prof. Bartsch has a longstanding clinical and scientific focus on breast cancer. Together with his colleagues, he has published over 150 articles in peer-reviewed journals, among them Annals of Oncology, Journal of Clinical Oncology, Clinical Cancer Research and Lancet Oncology.

Disclosures:
Grant/research support from Daiichi Sankyo, Novartis and Roche; Honoraria from Accord Healthcare, AstraZeneca, Bristol-Myers Squibb, Celgene, Eli Lilly, Novartis, Pfizer, Roche and Sandoz; Advisory Board fees from AstraZeneca, Celgene; Daiichi Sankyo, Eisai, Eli Lilly, MSD, Novartis, Roche and Samsung.

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Prof. Sibylle Loibl
German Breast Group, Neu-Isenburg, Germany
Exploring the impact of recent data on the management of HER2-positive advanced breast cancer

Prof. Sibylle Loibl discusses how novel treatment options may influence the future clinical management of patients with HER2-positive advanced breast cancer.

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Interview Questions

In this interview, Prof. Sibylle Loibl answers the following questions:

  • With data emerging for the novel therapies tucatinib, trastuzumab deruxtecan and neratinib, how might these impact current practice?
  • What are the key treatment-emergent adverse events experienced with these agents and how might they impact uptake in clinical practice?
  • What patient- and/or disease-related characteristics impact the choice of treatment?
  • How might ongoing phase III trials in HER2-positive advanced breast cancer impact patient management in the future?
About Prof. Sibylle Loibl

Sibylle Loibl, MD, PhD, is Chief Executive Officer and Chair of the German Breast Group (GBG), one of the leading study groups for breast cancer worldwide. She devotes the majority of her time to clinical trial research at the GBG and at her clinical affiliations – the University of Frankfurt and Oncology Bethanien, both in Frankfurt. read more

Prof. Loibl is internationally renowned in the fields of neoadjuvant breast cancer, breast cancer during pregnancy, and breast cancer in young women. She developed the translational research division within the GBG and has led numerous translational projects as well as research projects funded by the European Union Commission. She has led and participated in more than 100 national and international clinical trials in the field of breast cancer.

In 2014, she joined the Executive Board of the Breast International Group (BIG). As a medical expert, she serves on several international steering committees, translational research committees, and independent data monitoring committees.

Prof. Loibl has co-authored almost 300 Medline-listed scientific papers, in addition to more than 200 original and peer-reviewed articles and 30 books or book chapters. She has also actively contributed to more than 200 national and international congresses. She is an active member of numerous national and international organizations such as the American Society of Clinical Oncology and European Society of Medical Oncology.

Disclosures:
Grant/research support from Abbvie, Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Immunomedics, Novartis, Pfizer and Roche; Consultant/advisory board fees from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Daiichi Sankyo, Eli Lilly, Immunomedics, Merck, MSD, Novartis, Pierre Fabre, Pfizer, Puma Biotechnology, Roche, Seagen and Samsung; Speaker bureau fees from AbbVie, Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Eli Lilly, Novartis, Pfizer, Roche, Seagen and Samsung; Other Chugai Pharmaceutical Co.

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Overview & Learning Objectives
Overview

In this activity, experts in HER2-positive breast cancer discuss the rationale and evidence for recently approved and emerging novel therapies and their potential impact in the management of patients with HER2-positive advanced breast cancer.
This activity has been jointly provided by Oakstone and touchIME ONCOLOGY. Oakstone Publishing is accredited by the ACCME to provide continuing medical education to physicians. read more

Target audience

This activity has been designed to meet the educational needs of oncologists involved in the management of patients with breast cancer.

Disclosures

Oakstone Publishing has assessed conflict of interest with its faculty, authors, editors, and any individuals who were in a position to control the content of this CME activity. Any identified relevant conflicts of interest were resolved for fair balance and scientific objectivity of studies utilized in this activity. Oakstone Publishing’s planners, content reviewers, and editorial staff disclose no relevant commercial interests.

Faculty

Dr Eva Ciruelos discloses: Consultant/advisory board fees and congress assistance from Eli Lilly, Novartis, Pfizer and Roche.

Prof. Rupert Bartsch discloses: Grant/research support from Daiichi Sankyo, Novartis and Roche; Honoraria from Accord Healthcare, AstraZeneca, Bristol-Myers Squibb, Celgene, Eli Lilly, Novartis, Pfizer, Roche and Sandoz; Advisory Board fees from AstraZeneca, Celgene; Daiichi Sankyo, Eisai, Eli Lilly, MSD, Novartis, Roche and Samsung.

Prof. Sibylle Loibl discloses: Grant/research support from Abbvie, Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Immunomedics, Novartis, Pfizer and Roche; Consultant/advisory board fees from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Daiichi Sankyo, Eli Lilly, Immunomedics, Merck, MSD, Novartis, Pierre Fabre, Pfizer, Puma Biotechnology, Roche, Seagen and Samsung; Speaker bureau fees from AbbVie, Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Eli Lilly, Novartis, Pfizer, Roche, Seagen and Samsung; Other Chugai Pharmaceutical Co.

Content Reviewer

Walter Murray Yarbrough, MD, FACP, has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Director

Kathy Day has no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

Oakstone Publishing designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit™️. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

In order to receive credit for this activity, participants must review and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 Credit™ into European CME credit (ECMEC) should contact the UEMS (www.uems.eu)

Date of original release: 14 December. Date credits expire: 14 December.

Learning Objectives

After watching this activity, you should be able to:

  • Outline the rationale for novel treatment options for HER2-positive advanced breast cancer
  • Recall the clinical data for emerging later-line treatment options for patients with HER2-positive advanced breast cancer
  • Describe how novel treatment options may impact future management and address unmet needs in patients with HER2-positive breast cancer

This content is intended for healthcare professionals only. Please confirm that you are a healthcare professional.

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Question 1/4
Which of the following is one of the mechanisms implicated in the development of resistance to trastuzumab in HER2-positive advanced breast cancer?
Abbreviations: FGFR1, fibroblast growth factor receptor 1, HER2, human epidermal growth factor receptor 2; PTK6, protein tyrosine kinase 6; T-DM1, trastuzumab emtansine.
Correct

Different mechanisms responsible for de novo (primary) and acquired (secondary) resistance to trastuzumab have been identified:1

  • Impaired binding of trastuzumab to HER2, due to low HER2 levels, HER2 receptor variants or molecular masking
  • Altered intracellular signaling (e.g., constitutive activation of the PI3K/AKT/mTOR pathway)
  • Cross-signaling to HER2
  • Activation of the cyclin D1-CDK 4/6 axis
  • Escape from ADCC

ADCC, antibody-dependent cellular cytotoxicity; CDK 4/6; cyclin D1/cyclin-dependent kinase 4/6; FGFR1, fibroblast growth factor receptor 1, HER2, human epidermal growth factor receptor 2; PTK6, protein tyrosine kinase 6.

Reference

  1. Vernieri C, et al. Crit Rev Oncol Hematol. 2019;139:53–66.
Question 2/4
Which statement about the HER2CLIMB trial in women with HER2-positive breast cancer is correct?
Abbreviations: HER2, human epidermal growth factor receptor 2; ORR, objective response rate; PFS, progression-free survival.
Correct

HER2CLIMB was a phase III trial that evaluated tucatinib plus capecitabine and trastuzumab in heavily pretreated HER2-positive metastatic breast cancer, including patients with brain metastasis. For the first 480 patients who underwent randomization, 1-year PFS and median duration of PFS were respectively 33.1% and 7.8 months in the tucatinib-combination arm vs 12.3% and 5.6 months in the placebo-combination arm.1

HER2, human epidermal growth factor receptor 2; PFS, progression-free survival.

Reference

  1. Murthy RK, et al. N Engl J Med. 2020;382:597–609.
Question 3/4
Your patient with HER2-positive breast cancer has gone through multiple lines of treatment and has cancer that has spread to the brain. What would be your treatment choice for this patient, if all agents were available to you?
Correct

Tucatinib in combination with trastuzumab gained FDA approval in April 2020 for the treatment of adults with advanced unresectable or metastatic HER2-positive breast cancer who have received ≥1 prior anti-HER2-based regimens in the metastatic setting. The approval includes patients with brain metastases.1

The clinical trial, HER2CLIMB, supporting this approval enrolled and specifically studied patients with active brain metastases. Of the 291 patients with brain metastasis, 198 were in the tucatinib arm and 93 in the control arm. The risk of intracranial progression or death was reduced by 68% in the tucatinib arm (HR, 0.32; 95% CI, 0.22–0.48; p< 0.0001).2

CI, confidence interval; FDA, US Food and Drug Administration; HR, hazard ratio; HER2, human epidermal growth factor receptor.2

References

  1. FDA. Tucatinib prescribing Information. April 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213411s000lbl.pdf (accessed 21 October 2020).
  2. Lin NU, et al. J Clin Oncol. 2020;38:2610–9.
Question 4/4
Your patient with HER2-positive advanced breast cancer has started third-line treatment with trastuzumab deruxtecan, what treatment-related adverse event should you carefully monitor for and manage in this patient?
Correct

The FDA’s approval of trastuzumab deruxtecan included a special warning for clinicians on the risk of the lung-related side effects, known as interstitial lung disease. Clinicians should advise patients of the risk and to immediately report symptoms.1

Clinicians should monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. They should permanently discontinue trastuzumab deruxtecan in all patients with grade 2 or higher interstitial lung disease/pneumonitis.1,2

FDA, US Food and Drug Administration.

References

  1. FDA. Trastuzumab deruxtecan prescribing Information. December 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761139s000lbl.pdf (accessed 21 October 2020).
  2. Modi S, et al. N Engl J Med. 2020;382:610–21.
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