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About This Activity

Activity Description and Learning Objectives

In this activity, experts in breast cancer discuss unmet needs for patients with HER2-positive breast cancer and brain metastases, key clinical trial data for emerging treatment options and how they translate to changes in clinical practice.

This activity has been jointly provided by Oakstone and touchIME. Oakstone Publishing is accredited by the ACCME to provide continuing medical education to physicians.

After watching this activity, participants should be better able to:

Target Audience

This activity is 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 Sandra M Swain disclosures: Personal fees for consulting/advisory services from: AstraZeneca, Athenex, Daiichi-Sankyo, Eli Lilly & Company, Genentech/Roche, Genomic Health, Inivata Ltd, Molecular Templates, Pieris Pharmaceuticals, Silverback Therapeutics and Tocagen. Non-financial support (i.e. travel, accommodations and/or food and beverage) from: Athenex, Bristol-Myers Squibb, Caris Life Sciences, Daiichi-Sankyo, Eli Lilly & Company, Genentech/Roche, Inivata Ltd and Novartis. Research support (to institution) from: Genentech/Roche and Pfizer. Member of independent data-monitoring committee for: AstraZeneca. Third-party writing assistance from: Roche.

Dr Sara A Hurvitz disclosures: Grants/research support from: Ambrx, Amgen, Arvinas, Bayer, Daiichi-Sankyo, Dignitana, Eli Lilly, Genentech, GlaxoSmithKline, Immunomedics, MacroGenics, Novartis, OBI Pharma, Pfizer, Pieris, Puma Biotechnology, Radius Health, Roche, Sanofi and Seattle Genetics. Stockholder in: NKMaX. Travel support from: Eli Lilly.

Dr Nancy U Lin disclosures: Research support from: Genentech, Pfizer, Seattle Genetics and Zion Pharmaceuticals. Honorarium from: California Institute for Regenerative Medicine, Daiichi Sankyo, Denali Therapeutics, Puma Biotechnology and Seattle Genetics. Travel expense reimbursement from: Puma Biotechnology and Seattle Genetics.

Content Reviewer

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

Touch Medical Director

Hannah Fisher has no financial interests/relationships or affiliations in relation to this activity.

Requirement for Successful Completion

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Oakstone Publishing and touchIME. Oakstone Publishing is accredited by the ACCME to provide continuing medical education for physicians.

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. A score of 70% or higher is needed to obtain CME credit. 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: August 06, 2020. Date credits expire: August 06, 2021.

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Q1. Your patient is a 42-year-old woman with HER2-positive breast cancer. She is currently receiving T-DM1 and has stable disease; however, she is found to have a brain metastasis following an MRI scan. According to the 2018 ASCO guidelines for the management of patients with HER2-positive breast cancer and brain metastases, what should you do next?

ASCO, American Society of Clinical Oncology; MRI, magnetic resonance imaging; T-DM1, trastuzumab emtansine.

  1. A. Add pertuzumab to current T-DM1 treatment
  2. B. Continue treatment with T-DM1
  3. C. Suspend current therapy and start whole brain radiotherapy
  4. D. Switch to a different systemic treatment

Please try again

The 2018 ASCO guidelines for patients with HER2-positive breast cancer and brain metastases recommend that the systemic therapy should not be switched for patients whose systemic disease is not progressive at time of brain metastasis diagnosis.

Reference

  • Ramakrishna N, et al.  J Clin Oncol. 2018;36:2804–7.

Q2. Patients with HER2-positive metastatic breast cancer and progressing brain metastases were permitted for inclusion into which of the following trials?

  1. A. Phase III NALA trial comparing neratinib + capecitabine versus lapatinib + capecitabine
  2. B. Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan
  3. C. Phase II HER2CLIMB trial comparing tucatinib + trastuzumab + capecitabine versus placebo + trastuzumab + capecitabine

Please try again

The phase II HER2CLIMB trial assessed tucatinib + trastuzumab + capecitabine versus placebo + trastuzumab + capecitabine in patients with HER2-positive metastatic breast cancer and included patients with untreated, treated stable and treated and progressing brain metastases. The phase III NALA trial included patients with asymptomatic or stable brain metastases and the phase II DESTINY-Breast01 trial included patients with treated and asymptomatic brain metastases.

References

  • Murthy RK, et al.  N Engl J Med. 2020;382:597–609.
  • Lin NU, et al.  J Clin Oncol. 2020;38:1005.
  • Saura C, et al.  J Clin Oncol. 2020;JCO2000147. doi: 10.1200/JCO.20.00147 [Epub ahead of print].
  • Modi S, et al.  N Engl J Med. 2020;382:610–21.

Q3. Which of the following statements is true regarding the outcomes for patients with HER2-positive breast cancer treated with trastuzumab deruxtecan in the DESTINY-Breast01 trial?

  1. A. Median progression-free survival was higher in patients with brain metastases than in the overall population
  2. B. Median progression-free survival was lower in patients with brain metastases than in the overall population
  3. C. Objective response rate in the overall population was 40%
  4. D. Objective response rate in the overall population was <10%

Please try again

Median progression-free survival was 16.4 months in the overall population and 18.1 months in the patients with brain metastases. The objective response rate in the overall population was 61%.

Reference

  • Modi S, et al.  N Engl J Med. 2020;382:610–21.

Q4. Your patient is a 49-year-old woman with metastatic breast cancer. HER2 testing of her primary tumour was IHC 2+, FISH ratio 2.2, HER2 copy number 4.3. A metastatic biopsy showed HER2 IHC 2+, FISH ratio 2.1, HER2 copy number 4.0. She has received prior treatment with taxane/trastuzumab/pertuzumab and T-DM1; however, she had a poor response to these treatments. Which of the following may be the most suitable option for this patient’s next treatment regimen?

FISH, fluorescence in situ hybridization; IHC, immunohistochemistry; ISH, in situ hybridization; T-DM1, trastuzumab emtansine.

  1. A. Tucatinib + trastuzumab + capecitabine
  2. B. Neratinib + capecitabine
  3. C. Trastuzumab deruxtecan
  4. D. Neratinib

Please try again

This patient has HER2-positive disease by ASCO-CAP (American Society of Clinical Oncology/College of American Pathologists) criteria, though not strongly HER2 positive given the FISH ratio and HER2 copy number. Treatment with anti-HER2 therapy would be considered standard of care; however, she has not responded well to two lines of standard anti-HER2 therapy. Early clinical data demonstrated promising preliminary antitumour activity for trastuzumab deruxtecan also in patients with HER2-low breast cancer (IHC 1+ or 2+/ISH negative). The DESTINY-Breast01 trial included 28 patients who were IHC 1+ or 2+ and ISH positive, and these patients experienced an objective response of 46% to trastuzumab deruxtecan. The ongoing DESTINY-Breast04 trial is testing trastuzumab deruxtecan versus chemotherapy in HER2-low, FISH-negative patients.

References

  • Wolff AC, et al.  Arch Pathol Lab Med. 2018;142:1364–82.
  • Modi S, et al.  Cancer Res. 2019;79(Suppl. 4):AbstractP6-17-02.
  • Modi S, et al.  J Clin Oncol. 2020;38:1887–96.
  • ClinicalTrials.gov. NCT03734029. Available at:  www.clinicaltrials.gov/ct2/show/NCT03734029. Accessed July 2020.
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touchEXPERT OPINIONS

Managing brain metastases in advanced
HER2-positive breast cancer: Where are we now?

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Introduction

Watch leading breast cancer specialists from the USA discuss the unmet needs for patients with HER2-positive breast cancer and brain metastases, the trial data for emerging treatments and the evolving treatment paradigm.

Dr Sandra M Swain, Georgetown University Medical Center and MedStar Health, Washington, DC, USA, outlines the link between HER2 overexpression and brain metastases, and why new treatments are needed for patients with HER2-positive breast cancer and brain metastases.

Dr Sara A Hurvitz, University of California, Los Angeles (UCLA), CA, USA, summarizes the data for emerging treatment options neratinib, tucatinib and trastuzumab deruxtecan.

Dr Nancy U Lin, Dana-Farber Cancer Institute, Boston, MA, USA, considers how these agents may influence clinical practice.

This activity is intended for oncologists involved in the management of patients with breast cancer.

Learning Objectives

After watching this touchEXPERT OPINIONS, you should be able to:

  • Recognize the unmet needs of patients with advanced HER2-positive breast cancer and brain metastases
  • Review the clinical data for emerging treatment options for patients with advanced HER2-positive breast cancer and brain metastases
  • Determine how novel HER2-targeted therapies may change the future management of patients with HER2-positive breast cancer and brain metastases