Clinical Trials: Improving Care of Women with Breast Cancer Through Research

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1 Clinical Trials: Improving Care of Women with Breast Cancer Through Research Som Mukherjee MD, MSc, FRCP(C) Life After Breast Cancer October 17, 2013

2 Breast Cancer

3 Is research making a difference?

4 Waging the war against cancer

5 Questions to answer today What is a clinical trial? How has research in breast cancer helped us get to where we are today? What are the pros and cons of joining a clinical trial? Breast cancer trials at the Juravinski Cancer Centre: is there a study out there that can help me? What does the future hold for breast cancer research?

6 Why is cancer such a difficult disease to cure?

7 Inside the Breast Cancer Cell

8 How did we get here? A Brief History of Breast Cancer Research

9 Earliest research 1600 B.C. Ancient Egypt Several cases of ulcerous tumours of the breast It was written that there is no treatment

10 A Brief History In the 1700 s, it was commonly thought that breast cancer was caused by: too little sexual activity too much sexual activity trauma to the breast clothing that was too tight

11 History of Breast Cancer Breast cancer was not as common until 1800 s, when infectious diseases were better controlled, sanitation improved and lifespan started to increase dramatically At that time, surgery had a high mortality rate

12 Life Expectancy

Age and Risk of Breast Cancer Age 0-39 1 in 203 women Age 40 to 59 1

13 Age and Risk of Breast Cancer Age in 203 women Age 40 to 59 1 in 27 women Age 60 to 69 1 in 28 women Age 70 and older 1 in 15 women

14 Breast Cancer Research Surgery Dr. Halstead ( ) published research on the radical mastectomy and this dramatically improved mortality rates in breast cancer Modified radical mastectomy Lumpectomy and radiation vs. mastectomy

15 Breast Cancer Research: Hormonal Therapy Sir George Beaton, Scottish Surgeon discovered the link between breast cancer and hormones Published 3 cases of women with breast cancer which shrunk dramatically after removal of their ovaries, which was performed for other reasons

16 Breast Cancer Research - Chemotherapy 1960 s Dr. Fisher and Dr. Bonnadonna discovered that chemotherapy given after surgery improved the cure rate for breast cancer patients anthracyclines (doxorubicin, adriamycin) 1987 paclitaxel found to be effective (Taxol) 2000 s Hamilton-led trials: MA-5, Dr. Mark Levine et al CEF vs. CMF MA-21, Dr. Mark Levine et al CEF, AC/T, dose dense EC/T

17 Back to the present: Clinical Trials at the JCC

18 What is a Clinical Trial? A clinical trial is a type of research that uses human volunteers (also called participants) and is intended to add to medical knowledge Clinical trials allow patients the possibility to receive a new type of treatment or test

19 Types of Research at the JCC

20 Clinical Trials at the JCC The Clinical Trials Department at JCC is one of the largest in Canada Oncologists recruit patients to over 70 different clinical trials at JCC every year Many breast cancer clinical trials currently open at JCC

21 Recent JCC Clinical Trials in Breast Cancer

22 1. Radiation Trials Dr. Tim Whelan Radiation trials looking at fewer number of treatments following surgery for breast cancer 16 treatments equivalent to 25 treatments for women with early stage breast cancer following lumpectomy this has impacted on treatment across the world Looking at trying to determine if 5 days of treatment suitable for certain patients

23 2. HERA Trial CANADA 71.5% NORDIC COUNTRIES EU EASTERN EUROPE: 11% JAPAN CENTRAL & SOUTH AMERICA 5.5% 12% ASIA PACIFIC SOUTH AFRICA AUSTRALIA NEW ZEALAND

24 Herceptin

25 HERA Trial Women who received chemotherapy after surgery were randomized to receive no Herceptin (trastuzumab) or 1 year of Herceptin or 2 years of Herceptin Results presented in 2006 showed that 1 year of Herceptin was better than no Herceptin (recurrence rate almost half at 2 years) Cure rates for HER2 +ve breast cancer have improved significantly (24% decrease) since the arrival of Herceptin

26 Insulin and Cancer

3. MA-32: Metformin in Breast Cancer New research suggests that insulin helps to increase the ability of cancer cells to grow, divide and spread Clinical trial of metformin in breast cancer has

27 3. MA-32: Metformin in Breast Cancer New research suggests that insulin helps to increase the ability of cancer cells to grow, divide and spread Clinical trial of metformin in breast cancer has completed accrual Preliminary results presented at ASCO 2013 showed that metformin resulted in weight loss, improved glucose levels and lower insulin levels Awaiting results of data looking at breast cancer recurrence rates

28 4. LISA Trial Randomized controlled trial evaluating the usefulness of a telephone-based lifestyle intervention vs. written material Results presented at ASCO 2013 Showed that significant weight loss was seen after 6, 12 and 18 months of a lifestyle intervention

29 5. Hamilton led MA-21 trial Women with high risk breast cancer randomized to one of 3 treatment groups: AC/T every 3 weeks Dose dense EC/T CEF chemotherapy Results showed that AC/T given every 3 weeks was not as effective as the other 2 regimens

6. Oncotype Dx Trials Oncotype Dx is a new tool that helps oncologists determine if a patient might benefit from adjuvant chemotherapy (following surgery)

30 6. Oncotype Dx Trials Oncotype Dx is a new tool that helps oncologists determine if a patient might benefit from adjuvant chemotherapy (following surgery) McMaster University/JCC are leading this study through the Ontario Clinical Oncology Group to determine how often this test changes treatment plans in patients

31 Hope for the Future Knowledge gained from clinical trials has led the way and improved the treatment of breast cancer Generations of patients before us have helped us figure out how best to treat our patients Research gives us all hope

32 Working Together Worldwide Worldwide movement of research Conferences sharing research: CAMO, ASCO, ESMO

33 Are we making progress in breast cancer?

34 Better Prevention

35 Improved Diagnosis

36 Better Treatments Surgery Radiation

37 Better Treatments New breast cancer drugs approved by Health Canada over past 10 years: Herceptin (trastuzumab) and lapatinib (Tykerb) for HER2 +ve breast cancer T-DM1, pertuzumab Hormonal therapies aromatase inhibitors (letrozole (Femara), anastrazole (Arimidex), exemestane (Aromasin) Everolimus (Afinitor) Chemotherapy eribulin Bone agents denosumab, pamidronate

38 What about me? Why Should I Participate in Clinical Trials? Possibility that you could benefit yourself from new treatments Opportunity to help other patients in the future Increase global understanding of breast cancer

39 Active Breast Cancer Trials at the JCC Click on Clinical Trials

40 Journey Story on the battle against cancer not over yet Final chapter has yet to be written Our understanding of cancer has increased dramatically over the past 50 years and continues to increase on a daily basis

41 My Vision for the Future

42 Clinical trials are the vital link between breakthroughs in the lab and new treatments that extend and improve patients lives

43 The Real Heroes of Research (you!)

45 Thank You!

Adjuvant Systemic Therapy in Early Stage Breast Cancer

Adjuvant Systemic Therapy in Early Stage Breast Cancer Julie R. Gralow, M.D. Director, Breast Medical Oncology Jill Bennett Endowed Professor of Breast Cancer Professor, Global Health University of Washington