Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16:25-35. Abstract
Finn RS, Martin M, Rugo H, et al. PALOMA-2: Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375:1925-1936.
King TA, Lyman JP, Gonen M, et al. Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013. J Clin Oncol. 2016;34:2359-2365. Abstract
Garcia-Murillas I, Schiavon G, Weigelt B, et al. Science Transl Med. 2015;7:302ra133.
Patnaik A, Rosen LS, Tolaney SM, et al. Efficacy and safety of abemaciclib, an inhibitor of CDK4 and CDK6, for patients with breast cancer, non-small cell lung cancer, and other solid tumors. Cancer Discov. 2016;6:740-753. Abstract
Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17:425-439. Abstract
Turner NC, Jiang Y, O’Leary B, et al. Efficacy of palbociclib plus fulvestrant (P+F) in patients (pts) with metastatic breast cancer (MBC) and ESR1 mutations (mus) in circulating tumor DNA (ctDNA). J Clin Oncol. 2016;34(Suppl):Abstract 512.
Hamilton E, Infante JR. Targeting CDK4/6 in patients with cancer. Cancer Treat Rev. 2016;45:129-138. Abstract
Arnedos M, Cheaib B, Bayar M, et al. Anti-proliferative response and predictive biomarkers to palbociclib in early breast cancer: The Preoperative Palbociclib (POP) randomized trial. Presentation at the 107th AACR Meeting, New Orleans, Louisiana, April 16-20, 2016;Abstract CT041.
Juric D, Hamilton E, Estevez L, et al. Phase Ib/II study of LEE011 and BYL719 and letrozole in ER+, HER2– breast cancer: Safety, preliminary efficacy and molecular analysis. Presentation at 37th SABCS 2014; San Antonio, Texas, December 9-13, 2014: Abstract P5-19-24.
Herrera-Abreu MT, Palafox M, Asghar U, et al. Cancer Res. 2016;76:2301-2313. Abstract

CPD

CDK4/6 Biomarkers: Issues and Opportunities

Authors: Fabrice André, MD
CPD Released: 12/23/2016
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 12/23/2017, 11:59 PM EST

Target Audience and Goal Statement

This educational activity is intended for an international audience of non-US healthcare professionals, specifically oncologists, obstetricians/gynecologists, and pathologists involved in the treatment of patients with hormone receptor (HR)-positive breast cancer.

The goal of this activity is to improve physicians’ understanding regarding the development and use of prognostic biomarkers for patient selection and response to cyclin-dependent kinase (CDK)4/6 inhibitors in HR-positive breast cancer patients.

Upon completion of this activity, participants will:

Have greater competence related to
1. Use of genomic tests for identifying responses to CDK4/6 inhibitors
Have increased knowledge regarding the
1. Use of biomarkers to assess patient response to CDK4/6 inhibitors
2. Scientific basis regarding how a patient may respond to a CDK4/6 inhibitor combination therapy in HR-positive breast cancer

Disclosures

WebMD Global requires each individual who is in a position to control the content of one of its educational activities to disclose any relevant financial relationships occurring within the past 12 months that could create a conflict of interest.

Moderator(s)

Fabrice André, MD

Full Professor, Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France; Head, Research Lab, INSERM Unit U981: Biomarkers and new therapeutic targets in cancer

Disclosures

Disclosure: Fabrice André, MD, has disclosed the following relevant financial relationships:
Received grants for clinical research from: AstraZeneca; Eli Lilly and Company; Novartis Pharmaceuticals Corporation; Pfizer Inc.;

Steering Committee

Nadia Harbeck, MD, PhD

Professor, Breast Center, Department of Obstetrics and Gynecology, University of Munich (LMU), Munich, Germany

Disclosures

Disclosure: Nadia Harbeck, MD, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Lilly; Novartis Pharmaceuticals Corporation; Pfizer Inc.
Served as a speaker or a member of a speakers bureau for: Novartis Pharmaceuticals Corporation; Pfizer Inc.

Javier Cortés, MD, PhD

Head, Breast Cancer and Gynecological Tumours, Ramón y Cajal University Hospital, Oncology Department, Madrid, Spain; Clinical

Disclosures

Disclosure: Investigator, Breast Cancer Research Program, Vall d’Hebron Institute of Oncology, Barcelona, Spain Javier Cortés, MD, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: AstraZeneca Pharmaceuticals LP; Bi
Othera Pharmaceuticals, Inc.; Celgene Corporation; Cellestia Biotech; Roche
Served as a speaker or a member of a speakers bureau for: Celgene Corporation; Eisai Co., Ltd; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Roche

Angelo Di Leo, MD, PhD

Head, Medical Oncology Unit; Chair, Oncology Department, “Sandro Pitigliani” Medical Oncology Unit - Department of Oncology, Hospital of Prato, Istituto Toscano Tumori, Prato, Italy

Disclosures

Disclosure: Angelo Di Leo, MD, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: AstraZeneca Pharmaceuticals LP; Bayer HealthCare Corporation; Celgene Corporation; Eisai Co., Ltd; Genomic Health; Ipsen; Eli Lilly and Company; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Pierre Fabre; Roche

Stephen R.D. Johnston, MA, FRCP, PhD

Professor of Breast Cancer Medicine, Royal Marsden Hospital, London, United Kingdom

Disclosures

Disclosure: Stephen R.D. Johnston, MA, FRCP, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: AstraZeneca Pharmaceuticals LP; Novartis Pharmaceuticals Corporation; Pfizer Inc; Puma Biotechnology; Roche
Served as a speaker or a member of a speakers bureau for: AstraZeneca Pharmaceuticals LP; GlaxoSmithKline; Pfizer Inc; Puma Biotechnology
Received grants for clinical research from: GlaxoSmithKline; Pfizer Inc

Xavier Pivot, MD, PhD

Professor, J Minjoz University Hospital, Besançon, France

Disclosures

Disclosure: Xavier Pivot, MD, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Amgen Inc.; Novartis Pharmaceuticals Corporation; Roche
Served as a speaker or a member of a speaker's bureau for: Eisai Co., Ltd; Novartis Pharmaceuticals Corporation; Roche

Sunil Verma, MD, MSEd, FRCPC

Professor, Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada

Disclosures

Disclosure: Sunil Verma, MD, MSEd, FRCPC, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: AstraZeneca; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Roche

Editor(s)

Deb Middleton, MS

Scientific Director, WebMD Global, LLC

Disclosures

Disclosure: Deb Middleton, MS, has disclosed no relevant financial relationships.

Content Reviewer

Robert Morris, PharmD

Associate CME Clinical Director

Disclosures

Disclosure: Robert Morris, PharmD, has disclosed no relevant financial relationships.

Accreditation Statements

For Physicians

The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom (FPM) has reviewed and approved the content of this educational activity and allocated it 0.25 continuing professional development credits (CPD).

Contact WebMD Global

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

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There are no fees for participating in or receiving credit for this online educational activity. For information about your eligibility to claim credit, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent participating in the activity. To successfully earn credit, participants must complete the activity online during the credit eligibility period that is noted on the title page.

Follow these steps to claim a credit certificate for completing this activity:

Read the information provided on the title page regarding the target audience, learning objectives, and author disclosures, read and study the activity content and then complete the post-test questions. If you earn a passing score on the post-test and we have determined based on your registration profile that you may be eligible to claim CPD credit for completing this activity, we will issue you a CPD credit certificate.
Once your CPD credit certificate has been issued, you may view and print the certificate from your CME/CE Tracker. CPD credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of the Medscape Education homepage.

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You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

*The credit that you receive is based on your user profile.

From Medscape Education

CPD

CDK4/6 Biomarkers: Issues and Opportunities

Authors: Fabrice André, MDFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CPD Released: 12/23/2016

Valid for credit through: 12/23/2017, 11:59 PM EST

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CPD Information Download Slides

Disclaimer

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 WebMD Global, LLC or companies that support educational programming on medscape.org. These materials may discuss therapeutic products that have not been approved by the European Medicines Agency for use in Europe 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)

Fabrice André, MD

Steering Committee

Nadia Harbeck, MD, PhD

Javier Cortés, MD, PhD

Angelo Di Leo, MD, PhD

Stephen R.D. Johnston, MA, FRCP, PhD

Xavier Pivot, MD, PhD

Sunil Verma, MD, MSEd, FRCPC

Editor(s)

Deb Middleton, MS

Content Reviewer

Robert Morris, PharmD

CPD

CDK4/6 Biomarkers: Issues and Opportunities

Target Audience and Goal Statement

Disclosures

Moderator(s)

Fabrice André, MD

Steering Committee

Nadia Harbeck, MD, PhD

Javier Cortés, MD, PhD

Angelo Di Leo, MD, PhD

Stephen R.D. Johnston, MA, FRCP, PhD

Xavier Pivot, MD, PhD

Sunil Verma, MD, MSEd, FRCPC

Editor(s)

Deb Middleton, MS

Content Reviewer

Robert Morris, PharmD

Accreditation Statements

For Physicians

Instructions for Participation and Credit

CDK4/6 Biomarkers: Issues and Opportunities