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Faculty & Disclosures

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    Faculty & Disclosures
    Prof. Giuseppe Curigliano

    University of Milan
    Milan, Italy

    Giuseppe Curigliano is professor of medical oncology at the University of Milan and chief of the Clinical Division of Early Drug Development at the European Institute of Oncology, Milan, Italy – one of the world’s leading cancer-research institutes – where he also had a tenure track position and is a full-time cancer specialist. read more

    Prof. Curigliano is an expert in the field of advanced drug development in solid tumours, with a specific interest in breast cancer, and he has contributed to the development of many anticancer treatments for solid tumours currently available as standard of care.

    Prof. Curigliano is chairperson for the European Society for Medical Oncology Clinical Practice Guidelines Committee and is a member of the Italian Higher Health Council. Prof. Curigliano was awarded the first European School of Oncology Umberto Veronesi Award in 2017 and also received the Fellowship of the European Academy of Cancer Sciences in the same year. In 2022, Prof. Curigliano was identified as one of the Highly Cited Researchers by Clarivate™, as someone who has demonstrated significant and broad influence reflected in their publication of multiple highly cited papers over the last decade.

    Prof. Giuseppe Curigliano discloses: Advisory board or panel fees from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead Sciences, Inc., Menarini, Merck & Co., Novartis, Pfizer, Roche, Seagen (all relationships terminated). Consultancy fees from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead Sciences, Inc., Menarini, Merck & Co., Novartis, Pfizer, Roche, Seagen (all relationships terminated). Grants/research support from Merck & Co. Speakers bureau fees from Eli Lilly, Gilead Sciences, Inc. and Pfizer (all relationships terminated).
    Prof. Hope Rugo

    University of California
    San Francisco, CA, USA

    Hope S Rugo, professor of medicine, is a medical oncologist and haematologist specializing in breast cancer research and treatment. She is the director of Breast Oncology and Clinical Trials Education at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. read more

    Prof. Rugo is a principal investigator of multiple clinical trials focusing on combining novel targeted therapeutics with standard treatment to improve the treatment of both early- and late-stage breast cancer, and has published widely in this area.

    Prof. Rugo’s current research interests include immunotherapy and combinations of targeted agents to overcome resistance in breast cancer. Prof. Rugo has conducted a number of studies focusing on reducing toxicity from therapy. She is an investigator and the chair of the Safety Committee for the multicentre adaptively randomized phase II I-SPY2 trial, and also serves on the Novel Agents Committee. Prof. Rugo is the co-chair of the Triple Negative Working Group and an active member of the Translational Breast Cancer Research Consortium (TBCRC), and is the principal investigator of several TBCRC trials, including a multicentre immunotherapy trial funded by the Breast Cancer Research Foundation . She is an active member of the Alliance Breast Committee, as well as the American Society of Clinical Oncology, where she serves on the Guidelines Committee and is an editor for the Education Committee. In addition to her research, Prof. Rugo is an active clinician and is committed to education. At UCSF, Prof. Rugo runs the Bay Area Breast Cancer Forum, an evening educational session for breast cancer patients, families and friends.

    Prof. Rugo has received several awards, including one from the AP Giannini Foundation and a UCSF Clinical Cancer Center Investigator Research Program intramural award. In 2006, she was honoured for her work in breast cancer research by the Friends of the Breast Care Center.

    Prof. Hope Rugo discloses: Consultancy and advisory board fees from Daiichi Sankyo, Eisai, Mylan, Napo Pharmaceuticals and Puma Biotechnology. Grants/research support from Astellas Pharma, AstraZeneca, Daiichi Sankyo, Eli Lilly, Genentech, Gilead Sciences, Inc., GSK, Merck & Co., Novartis, OBI Pharma, Inc., Pfizer, Pionyr Immunotherapeutics, Roche, Sermonix Pharmaceuticals, Taiho Oncology, Inc. and Veru. Other financial or material support (royalties, patent, etc.) from AstraZeneca, Gilead Sciences, Inc. and Merck & Co.
    Prof. Peter Schmid

    Barts Cancer Institute
    London, UK

    Peter Schmid is professor of cancer medicine and the lead of the Centre of Experimental Cancer Medicine at Barts Cancer Institute (BCI), Queen Mary University, London, UK. He is also the clinical director of the Breast Cancer Centre and an honorary consultant medical oncologist at St Bartholomew’s Hospital, London, UK. read more

    Prof. Schmid is internationally recognized for his research and education leadership in breast cancer. His primary research goal is to improve the treatment of women with breast cancer by defining more effective and less toxic approaches. Specific research areas include cancer immunotherapy, triple negative breast cancer (TNBC), endocrine resistance and innovative biomarker-driven trial concepts. Prof. Schmid runs an international collaborative clinical and translational research programme. He also leads the academic breast cancer programme at St Bartholomew’s Hospital and BCI.

    Prof. Schmid oversees the conduct of early phase trials at St Bartholomew’s Hospital and BCI, with a particular interest in immunotherapy, innovative trial designs and circulating biomarkers. He is the principal investigator of several pivotal breast cancer studies, including the IMpassion130 trial that evaluated atezolizumab for advanced TNBC and led to the regulatory approval of the first immunotherapy for breast cancer. Prof. Schmid is also the lead investigator of the KEYNOTE-522 trial that is evaluating pembrolizumab in combination with neoadjuvant chemotherapy for early TNBC. His work has been published in many journals including the New England Journal of Medicine, Lancet, Lancet Oncology, JAMA Oncology, Nature Communications and the Journal of Clinical Oncology.

    Prof. Schmid is chair of the European Society for Medical Oncology breast cancer faculty, and is a member of several national and international cancer organizations and research groups.

    Prof. Peter Schmid discloses: Advisory board or panel fees from AstraZeneca, Bayer, Boehringer Ingelheim, Celgene, Eisai, Merck & Co., Novartis, Pfizer, Puma Biotechnology and Roche. Consultancy fees from AstraZeneca, Bayer, Boehringer Ingelheim, Celgene, Eisai, Merck & Co., Novartis, Pfizer, Puma Biotechnology and Roche. Grants/research support from Astellas Pharma, AstraZeneca, Genentech, Medivation, Novartis, OncoGenex Pharmaceuticals and Roche.
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    A visually engaging discussion designed to emulate a ‘live’ panel experience and provide clinicians with practical expert insights to address their clinical challenges. Useful tips below will show how to navigate the activity. Close

    New and emerging agents in HER2-negative metastatic breast cancer: Implications for current and future practice

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    Learning Objectives

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

    • Discuss how novel treatments may be integrated into clinical practice for HER2-negative mBC, including optimal patient identification and treatment sequencing
    • Identify considerations surrounding the use of ADCs and evaluate how safety management may support adherence in patients with HER2-negative mBC
    • Evaluate the latest data for novel and emerging ADCs in managing HER2-negative mBC
    Overview

    In this activity, three oncology experts discuss the expanding targeted treatment options for human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC), including optimal patient identification and treatment sequencing, before focusing on approved and emerging antibody–drug conjugates (ADCs) for HER2-negative mBC, including the latest efficacy and safety data and considerations for use in clinical practice. The discussion is guided by pre-canvassed questions provided by healthcare professionals involved in the management of patients with HER2-negative mBC.

    This activity is jointly provided by USF Health and touchIME. read more

    Target Audience

    Oncologists, including breast cancer specialists involved in the management of HER2-negative mBC.

    Disclosures

    USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

    Faculty

    Prof. Giuseppe Curigliano discloses: Advisory board or panel fees from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead Sciences, Inc., Menarini, Merck & Co., Novartis, Pfizer, Roche, Seagen (all relationships terminated). Consultancy fees from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead Sciences, Inc., Menarini, Merck & Co., Novartis, Pfizer, Roche, Seagen (all relationships terminated). Grants/research support from Merck & Co. Speakers bureau fees from Eli Lilly, Gilead Sciences, Inc. and Pfizer (all relationships terminated).

    Prof. Hope Rugo discloses: Consultancy and advisory board fees from Daiichi Sankyo, Eisai, Mylan, Napo Pharmaceuticals and Puma Biotechnology. Grants/research support from Astellas Pharma, AstraZeneca, Daiichi Sankyo, Eli Lilly, Genentech, Gilead Sciences, Inc., GSK, Merck & Co., Novartis, OBI Pharma, Inc., Pfizer, Pionyr Immunotherapeutics, Roche, Sermonix Pharmaceuticals, Taiho Oncology, Inc. and Veru. Other financial or material support (royalties, patent, etc.) from AstraZeneca, Gilead Sciences, Inc. and Merck & Co.

    Prof. Peter Schmid discloses: Advisory board or panel fees from AstraZeneca, Bayer, Boehringer Ingelheim, Celgene, Eisai, Merck & Co., Novartis, Pfizer, Puma Biotechnology and Roche. Consultancy fees from AstraZeneca, Bayer, Boehringer Ingelheim, Celgene, Eisai, Merck & Co., Novartis, Pfizer, Puma Biotechnology and Roche. Grants/research support from Astellas Pharma, AstraZeneca, Genentech, Medivation, Novartis, OncoGenex Pharmaceuticals and Roche.

    Content reviewer

    Danielle Walker, DNP, APRN, AGNP-C has no relevant financial relationships to disclose.

    Touch Medical Contributors

    Aniket Parikh and Katrina Lester have no financial interests/relationships or affiliations in relation to this activity.

    USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

    Requirements for Successful Completion

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

    If you have questions regarding credit please contact cpdsupport@usf.edu.

    Accreditations

    Physicians

    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 a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

    USF Health designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    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 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

    Advanced Practice Providers

    Physician Assistants may claim a maximum of 0.75 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

    The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

    Date of original release: 14 August 2023. Date credits expire: 14 August 2024.

    If you have any questions regarding credit please contact cpdsupport@usf.edu.

    This activity is CE/CME accredited

    To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

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    This Activity Is Funded By:

    An independent medical education grant from Gilead Sciences, Inc.
    This activity is jointly provided by USF Health and touchIME.

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 14 August 2023. Date credits expire: 14 August 2024.

    Claim Credit
    touchPANEL DISCUSSION
    New and emerging agents in HER2-negative metastatic breast cancer: Implications for current and future practice
    0.75 CE/CME credit
    Question 1/5
    Which of the following criteria support the use of first-line CDK4/6 inhibitors in patients with mBC?

    CDK4/6, cyclin dependent kinase 4/6; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mBC, metastatic breast cancer; PD-L1, programmed death-ligand 1; TNBC, triple-negative breast cancer.

    The standard of care for HR+/HER2-negative mBC is the combination of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) plus an endocrine agent in the first-line setting.1,2 All three CDK4/6 inhibitors have demonstrated significant improvements in PFS in first- or second-line treatment of patients with HR+/HER2-negative mBC.2

    Abbreviations

    CDK4/6, cyclin dependent kinase 4/6; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mBC, metastatic breast cancer; PFS, progression-free survival.

    References

    1. Grinshpun, A. NPJ Breast Cancer. 2023;9:15.
    2. Scirocchi F, et al. EBioMedicine. 2022;79:104010.
    Question 2/5
    Your 57-year-old female patient has HR+ mBC and a HER2 status of 0 according to IHC. She was previously treated with first-line fulvestrant plus ribociclib and experienced disease control for >18 months. She was subsequently treated with everolimus plus exemestane in the second line, and elacestrant in the third line. Following bone metastases, she received capecitabine but experienced liver metastases after 6 months of treatment. Which of the following treatments would you consider next, assuming all options are approved and available?

    HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IHC, immunohistochemistry; mBC, metastatic breast cancer.

    Sacituzumab govitecan is FDA- and EMA-approved for the treatment of patients with unresectable locally advanced or HR+/HER2-negative mBC (IHC 0, IHC 1+ or IHC 2+/ISH–) who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.1–3

    Abbreviations

    EMA, European Medicines Agency; FDA, US Food and Drug Administration; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IHC, immunohistochemistry; ISH, in situ hybridization; mBC, metastatic breast cancer.

    References

    1. FDA. Sacituzumab govitecan PI. Available at:
       https://bit.ly/45JgvH0 (accessed 12 July 2023).
    2. EMA. 2023. Available at: https://bit.ly/3QhVWvT (accessed 02 August 2023).
    3. Pharmaceutical technology. Available at: https://bit.ly/3YhfZMI (accessed 31 July 2023).
    Question 3/5
    Your 62-year-old female patient with HR+/HER2-negative mBC is about to initiate treatment with sacituzumab govitecan. Considering nausea and vomiting are common treatment-emergent side effects, what would you do next to best manage this patient?

    HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mBC, metastatic breast cancer.

    The FDA prescribing information and EMA summary of product characteristics for sacituzumab govitecan recommend premedication with a two- or three-drug combination regimen prior to each dose of sacituzumab govitecan for prevention of chemotherapy-induced nausea and vomiting.1,2

    Abbreviations

    EMA, European Medicines Agency; FDA, US Food and Drug Administration.

    References

    1. FDA. Sacituzumab govitecan PI. Available at: https://bit.ly/45JgvH0 (accessed 12 July 2023).
    2. EMA. Sacituzumab govitecan SmPC. Available at: https://bit.ly/3DseodE (accessed 12 July 2023).
    Question 4/5
    The TROPION-PanTumor01 trial is investigating the efficacy and safety of datopotamab deruxtecan in patients with HR+/HER2-negative mBC and mTNBC. Based on interim results, what was the ORR observed in these patients?

    HER2, human epidermal growth factor 2; HR, hormone receptor; mBC, metastatic breast cancer; mTNBC, metastatic triple-negative breast cancer; ORR, objective response rate.

    In the phase I TROPION-PanTumor01 trial (NCT03401385) investigating datopotamab deruxtecan in patients with HR+/HER2-negative unresectable or mBC,1 and patients with relapsed/refractory unresectable advanced or mTNBC, with 1–3 prior lines of chemotherapy,1 the ORR was 27% in patients with HR+/HER2–negative mBC,2 and 32% in patients with advanced or mTNBC.3

    Abbreviations

    HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mBC, metastatic breast cancer; mTNBC, metastatic triple negative breast cancer; ORR, objective response rate.

    References

    1. ClinicalTrials.gov. NCT03401385. Available at: bit.ly/3rNAO6B (accessed 27 July 2023).
    2. Bardia A, et al. Presented at: 40th Annual Miami Breast Cancer Conference, Miami, FL, USA. 2–5 March 2023;37:14–15.
    3. Bardia A, et al. Presented at: 40th Annual Miami Breast Cancer Conference, Miami, FL, USA. 2–5 March 2023;37:13–14.
    Question 5/5
    Based on data available from the DESTINY-Breast04 trial, how would you counsel your patients on the most common side effect they may experience with trastuzumab deruxtecan?

    TEAE, treatment-emergent adverse event.

    In the phase III DESTINY-Breast04 trial (NCT03734029), nausea was reported as the most common all-grade TEAE in patients with HR+/HER2-low mBC treated with trastuzumab deruxtecan, occurring in 73% of patients. By comparison, nausea was reported in 24% of patients treated with TPC.

    Abbreviations

    HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mBC, metastatic breast cancer; TEAE, treatment-emergent adverse event; TPC, treatment of physician’s choice.

    Reference

    Modi S, et al. N Engl J Med. 2022;387:9–20.

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    This Activity Is Funded By:

    An independent medical education grant from Gilead Sciences, Inc.
    This activity is jointly provided by USF Health and touchIME.

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 14 August 2023. Date credits expire: 14 August 2024.

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