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Tuesday, December 4, 2018, San Antonio, Texas, 7:30 PM – 10:00 PM

Addressing Current Questions and Controversies in the Management of Early and Advanced Breast Cancer

Event Details

Location:
San Antonio Marriott Rivercenter
101 Bowie Street
San Antonio, TX 78205
Hotel Phone: (210) 223-1000

Time:
7:30 PM – 10:00 PM — Educational Dinner Meeting

Meeting Room:
Grand Ballroom (Third Floor)

There is no registration fee for this event. However, preregistration is advised as seating is limited.

Faculty:
Harold J Burstein, MD, PhD
Associate Professor of Medicine
Harvard Medical School
Breast Oncology Center
Dana-Farber Cancer Institute
Boston, Massachusetts

William J Gradishar, MD
Betsy Bramsen Professor of Breast Oncology and Professor of Medicine
Deputy Director, Clinical Network
Robert H Lurie Comprehensive Cancer Center of Northwestern University
Director, Maggie Daley Center for Women’s
Cancer Care
Interim Chief, Division of Hematology/Oncology
Northwestern University Feinberg School of Medicine
Chicago, Illinois

Joyce O’Shaughnessy, MD
Chair, Breast Cancer Research Program
Baylor Charles A Sammons Cancer Center
Celebrating Women Chair in Breast Cancer Research
Texas Oncology
US Oncology
Dallas, Texas


Hope S Rugo, MD
Professor of Medicine
Director, Breast Oncology and Clinical
Trials Education
University of California, San Francisco
Helen Diller Family Comprehensive Cancer Center
San Francisco, California

Professor Peter Schmid, MD, PhD
Centre Lead
Centre for Experimental Cancer Medicine
Barts Cancer Institute
London, United Kingdom

Debu Tripathy, MD
Professor of Internal Medicine
Director, Komen UT Southwestern Breast Cancer Research Program
University of Texas Southwestern Medical Center
Dallas, Texas

Moderator:
Neil Love, MD
Research To Practice
Miami, Florida



Agenda

7:30 PM – 10:00 PM

MODULE 1: Neoadjuvant, Adjuvant and Extended-Adjuvant Therapy for Patients with Localized HER2-Positive Breast Cancer (BC) — Dr  Tripathy

Faculty Presentation Topics

  • Available Phase III data with, FDA approval of and patient selection for pertuzumab as a component of adjuvant chemobiologic therapy
  • Indications for the use of adjuvant pertuzumab in patients receiving it as a component of neoadjuvant therapy
  • Design, eligibility criteria and patient accrual to the Phase III KATHERINE study comparing T-DM1 to trastuzumab as adjuvant treatment for patients with HER2-positive early BC who have residual disease after neoadjuvant chemotherapy/trastuzumab
  • Invasive disease-free survival advantage associated with T-DM1 versus trastuzumab in the KATHERINE study; potential clinical implications
  • FDA approval of neratinib as extended-adjuvant therapy; patient selection and clinical factors (eg, ER/PR status, tumor size, nodal status) guiding its use in practice

Sample Discussion Questions Contributed by Consulting Medical Oncologists

  • Would you administer pertuzumab as a component of adjuvant systemic therapy to a patient who received neoadjuvant TCHP (docetaxel/carboplatin/trastuzumab/pertuzumab)? How would the patient’s response to neoadjuvant treatment affect this decision? Where might T-DM1 fit into all this?
  • Given that the data that we have with neratinib are after 1 year of adjuvant trastuzumab, how do you decide whether to administer this agent to a patient who received dual anti-HER2 therapy with trastuzumab and pertuzumab?
  • Is there any benefit to administering trastuzumab alone to an older, frail patient with high-risk HER2-positive disease who absolutely refuses chemotherapy?
  • Which patients do you consider for weekly paclitaxel and trastuzumab in the adjuvant setting? What is your practical limit for stopping the paclitaxel in these patients, particularly among older women who are experiencing significant peripheral neuropathy?

MODULE 2: Use of Genomic Classifiers to Assist in Clinical Decision-Making for Patients with ER-Positive Early BC — Dr  Gradishar

Faculty Presentation Topics

  • Design, eligibility criteria, primary and secondary endpoints and major clinical findings from the Phase III TAILORx intermediate-risk cohort
  • Clinical implications of the TAILORx intermediate-risk cohort results on adjuvant treatment decision-making
  • Recent updates to NCCN guidelines regarding the prioritization and current role of genomic assays in decision-making for patients with node-negative and node-positive, ER-positive early BC; current clinical utility of the 70-gene signature and other genomic classifiers beyond the 21-gene Recurrence Score® assay
  • Use of genomic assays to assist in clinical decision-making for patients completing 5  years of adjuvant endocrine therapy

Sample Discussion Questions Contributed by Consulting Medical Oncologists

  • What is the concordance between the 21-gene Recurrence Score on a biopsy specimen versus a surgical specimen? Can you use the Recurrence Score from a biopsy specimen to make a decision regarding neoadjuvant endocrine therapy versus chemotherapy?
  • How would tumor size affect your interpretation of the results of the TAILORx study? If you had a patient with a tumor that was approaching the 5-cm cutoff that was used in the study who would otherwise qualify for endocrine therapy alone, would you be more inclined to recommend chemotherapy?
  • What is the role of ovarian suppression for a premenopausal patient with a low-risk 21-gene Recurrence Score and 1 or 2 positive lymph nodes? In this scenario, would you consider omitting chemotherapy and administering endocrine therapy in combination with ovarian suppression or ablation?
  • In what situations, if any, are you using the 70-gene signature? If you were seeing a patient as a second opinion and the referring oncologist had ordered this assay, would you feel comfortable making a treatment recommendation based on the results?

MODULE 3: Selection and Sequence of Therapy for Patients with ER-Positive, HER2-Negative Metastatic BC (mBC); Ongoing Trials of CDK4/6 Inhibitors for Localized ER-Positive Disease — Dr  Burstein

Faculty Presentation Topics

  • Available data with and current clinical role of CDK4/6 inhibitors in premenopausal, postmenopausal and elderly patients
  • Comparative CNS activity of commercially available CDK4/6 inhibitors and implications, if any, for the care of patients with ER-positive brain metastases
  • Active clinical trials evaluating the use of novel CDK4/6 combinations in earlier disease settings
  • Incidence of phosphatidylinositol 3-kinase (PI3K) mutations in patients with hormone receptor-positive metastatic disease
  • Design, eligibility criteria and key efficacy and safety data from the Phase III SOLAR-1 trial evaluating alpelisib for patients with PIK3CA mutations; potential clinical role

Sample Discussion Questions Contributed by Consulting Medical Oncologists

  • In light of the neutropenia commonly observed in patients receiving CDK4/6 inhibitors, how do you approach holding these drugs for surgical procedures or in the event of a minor illness such as a urinary tract infection?
  • Is there any evidence that dose reducing CDK4/6 inhibitors results in decreased efficacy? How should one approach dosing in patients who have low baseline blood counts prior to the initiation of treatment?
  • Do you find any difference in potency of one CDK4/6 inhibitor versus another in particular clinical scenarios such as visceral disease? In a patient for whom a CDK4/6 inhibitor is being considered, would it be prudent to start with abemaciclib because its level of CNS penetration might provide prophylaxis against the development of brain metastases in the future?
  • Are there any data to support the use of CDK4/6 inhibitors in combination with anti-HER2 therapy in patients with ER-positive, HER2-positive metastatic disease?

MODULE 4: Management of Metastatic Triple-Negative BC; Available Research Data with and Ongoing Evaluation of Immune Checkpoint Inhibition in BC — Prof Schmid

Faculty Presentation Topics

  • Biologic rationale for the investigation of immune checkpoint inhibitors in BC
  • Early research experience with the use of anti-PD-1/PD-L1 antibodies alone or in combination with chemotherapy for patients with mBC
  • Design, entry criteria and accrual to the Phase III randomized IMpassion130 trial evaluating nanoparticle albumin-bound (nab) paclitaxel with atezolizumab or with placebo as first-line therapy for patients with locally advanced or metastatic triple-negative BC; key efficacy and safety findings in the overall study population and the PD-L1-positive subgroup
  • Ongoing Phase III studies evaluating anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies for patients with localized, locally advanced and metastatic BC

Sample Discussion Questions Contributed by Consulting Medical Oncologists

  • Should the average clinician practicing in the community setting routinely be testing all or certain subgroups of patients with mBC for PD-L1 expression? What about microsatellite instability or tumor mutational burden?
  • Would you rechallenge with a PD-1/PD-L1 antibody in a patient for whom it was discontinued because of autoimmune nephritis? What about for a patient who experienced autoimmune pneumonitis that resolved with steroid taper?
  • How long would you continue treatment with a PD-1/PD-L1 antibody in a patient who is tolerating therapy well and has stable disease? Indefinitely? For a finite period?
  • Is there reason to believe that any of the specific BC subtypes (eg, ER-positive, triple-negative) would be more sensitive to immune checkpoint inhibition than others? Where, if at all, should these agents ideally be incorporated into the therapeutic algorithm for patients with ER-positive and/or HER2-positive metastatic disease?

MODULE 5: Long-Term Management of HER2-Positive mBC; Treatment of HER2-Positive Brain Metastases; Novel Agents — Dr O’Shaughnessy

Faculty Presentation Topics

  • Management of triple-positive mBC; current and potential role of chemotherapy-free regimens
  • Available research data with and ongoing evaluation of neratinib/capecitabine for patients with HER2-positive mBC, including those with CNS metastases
  • Mechanism of action and associated CNS permeability of tucatinib; published activity and safety data with tucatinib in combination with trastuzumab/capecitabine for patients with HER2-positive mBC and ongoing HER2CLIMB study evaluating trastuzumab/capecitabine with or without tucatinib
  • Early efficacy and safety associated with the use of the antibody-drug conjugate trastuzumab deruxtecan (DS-8201a) for patients with HER2-positive mBC; FDA breakthrough therapy designation and ongoing Phase II/III investigation
  • Other novel agents and strategies under development for patients with HER2-positive mBC

Sample Discussion Questions Contributed by Consulting Medical Oncologists

  • What would you recommend for a patient who develops a single brain metastasis near the end of 12 months of adjuvant trastuzumab that is resected with no further evidence of disease? Would you observe, continue the trastuzumab or switch to another anti-HER2 therapy?
  • How would you compare the activity of T-DM1 in brain metastases to what has been observed with other anti-HER2 therapies (eg, trastuzumab, pertuzumab, lapatinib)?
  • In a patient who is experiencing a complete response to T-DM1 that has lasted for several years, would you consider a treatment holiday?
  • In a patient with HER2-positive mBC to whom you’d like to administer dual anti-HER2 treatment, do we have any data on the relative efficacy and tolerability of docetaxel versus weekly paclitaxel as a chemotherapy partner?

MODULE 6: PARP Inhibitors; Novel Targeted Agents and Other Emerging Therapeutic Strategies — Dr Rugo

Faculty Presentation Topics

  • Optimal integration of BRCA analysis into the treatment of metastatic BC
  • Underlying research databases supporting the FDA approvals of olaparib (OlympiAD) and talazoparib (EMBRACA); indications for genetic assessment in patients with BC
  • Mechanisms of action of sacituzumab govitecan, early efficacy and safety data supporting its FDA breakthrough designation and ongoing Phase III evaluation
  • Published research database documenting the presence of genomic alterations in various BC phenotypes; potential use of next-generation sequencing to prioritize research opportunities and/or guide clinical care

Sample Discussion Questions Contributed by Consulting Medical Oncologists

  • For a patient with ER-positive mBC and a known BRCA2 germline mutation whose disease has progressed through palbociclib/letrozole, would it be reasonable to combine a PARP inhibitor with fulvestrant? Would this combination be tolerable?
  • In a patient with a BRCA germline mutation who receives neoadjuvant chemotherapy and has significant residual disease at the time of surgery, could one extrapolate from the CREATE-X study and administer a PARP inhibitor in lieu of capecitabine?
  • Do you regularly use next-generation sequencing panels in your patients with mBC? What types of mutations are commonly found in these patients?
  • What other novel agents or strategies under development appear particularly promising for patients with mBC?

CE Information

Target Audience:
This activity is intended for medical oncologists, breast cancer surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer (BC).

Learning Objectives:
At the conclusion of this activity, participants should be able to:

  • Consider published data to guide the use of biomarkers and genomic classifiers to assess risk and customize therapy for patients with hormone receptor-positive BC in the adjuvant and extended-adjuvant settings.
  • Appraise available and emerging research evidence to individualize the selection and duration of neoadjuvant, adjuvant and/or extended-adjuvant therapy for patients with HER2-overexpressing early BC.
  • Develop an evidence-based algorithm for the treatment of advanced hormone receptor-positive pre- and postmenopausal BC, including the use of endocrine, biologic and chemotherapeutic agents.
  • Implement a long-term clinical plan for the care of patients with metastatic HER2-positive BC, incorporating existing and investigational targeted treatments.
  • Appreciate the biologic rationale for, available data with and ongoing evaluation of novel immunotherapeutic approaches in preparation for their potential introduction into BC clinical practice.
  • Appraise published efficacy and safety data with the use of PARP inhibitors in patients with metastatic BC harboring a BRCA1/2 mutation, and consider the diagnostic and therapeutic implications of these findings on clinical care.
  • Develop an understanding of the mechanisms of action of, available data with and potential clinical roles of other investigational compounds to facilitate referral for clinical trial opportunities or participation in expanded access programs.

CME Credit Form:
A CME credit form will be given to each participant at the conclusion of the activity.

Accreditation Statement:
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation Statement:
Research To Practice designates this live activity for a maximum of 2.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure Policy:
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Financial disclosures will be provided in meeting course materials.

Supporters:
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Genentech, Genomic Health Inc, Lilly, Merck, Puma Biotechnology Inc and Seattle Genetics.

Location

San Antonio Marriott Rivercenter
101 Bowie Street
San Antonio, TX 78205
Hotel Phone: (210) 223-1000

Meeting Room:
Grand Ballroom (Third Floor)

Directions:
The Marriott Rivercenter hotel is conveniently located within walking distance (1.5 blocks) of the Henry B González Convention Center.

 

Registration

This activity is intended for medical oncologists, breast cancer surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

There is no registration fee for this event. However, preregistration is advised as seating is limited.

Registration for clinicians in practice

I am a practicing physician, fellow, nurse or other healthcare provider involved in the treatment of cancer.

Registration for clinicians in practice »
 
Registration for other/industry professionals*

Please note, a limited number of seats are currently available for nonclinicians on a first come, first served basis.

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* Individuals employed by for-profit organizations, including financial institutions, biotech or pharmaceutical companies
Registration for groups
If you are registering a group (more than 1 person) for this event, please contact us at Meetings@ResearchToPractice.com or (800) 233-6153.
To ensure seating, please check in at our onsite registration desk at least 30 minutes before the start of the meeting. We cannot guarantee seating after the start of the program.

Meal service will be provided to those who attend the program, based on availability.

Photography and/or video recording may be taken during the educational program by Research To Practice and used in future educational programs.

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NOTICE: Registration for this event is independent of registration for the San Antonio Breast Cancer Symposium.