1. Why can’t we prevent breast cancer? Actually, we can … The treatment can be worse than the disease – The preventative can be worse than the risk Topics – Chemoprevention as a case study – The role of advocates – Current prevention research

2. Outline of Today’s Session John Park – Brief introduction to breast cancer prevention issues – Brief introduction to breast cancer advocacy at UCSF Hannah Klein Connolly – Advocate’s perspective Jeff Tice – Risk factors and risk assessment – Diet and other lifestyle factors Mary Beattie – Hereditary risk – Hormones

3. Chemoprevention OH OCH 2 CH 2 N CH 3CH3 Tamoxifen O N O S Raloxifene = use of drug treatment for disease prevention - In breast cancer, chemoprevention has been based on the well established importance of estrogen pathways in disease pathogenesis

4. NSABP-P1 Breast Cancer Prevention Trial 13,388 women – > 35 yo without any breast cancer history – “High risk”, i.e. Gail risk >1.7% 5-yr Randomized to 20 mg tamoxifen vs. placebo Stopped after average of 4 yrs

5. Tamoxifen reduced risk at all ages Age (years) Placebo Tamoxifen Fisher, et al. JNCI 1998;90:1371 Rate per 1,000 0 2 4 6 8 ≤49 50 - 59 ≥ 60

6. 7,705 postmenopausal women with osteoporosis 60 or 120 mg raloxifene vs. placebo Followed 4-6 years Multiple Outcomes of Raloxifene Evaluation (MORE) S Cummings

7. Raloxifene reduces the risk of invasive breast cancer Years % of participants % of participants 01234 0 0.5 1.0 1.0 1.52.05 Raloxifene 72%P<.00001 Placebo Cummings, et al JAMA 2000

8. Copyright restrictions may apply. Vogel, V. G. et al. JAMA 2006;295:2727-2741. Cumulative Incidence of Invasive and Noninvasive Breast Cancer

9. Why don’t we prevent breast cancer? Level 1 evidence with two approved drugs: tamoxifen, raloxifene Other drugs: aromatase inhibitors? Toxicities are modest in the cancer treatment setting Bottom line: chemoprevention is highly problematic for most women

10. Bay Area Breast SPORE 10 Advocacy Core Mission Mission: Provide peer advocacy support to the SPORE researchers, breast cancer patients, and the community at large by supporting and advancing projects that promote translational research. Advocacy Core

11. Bay Area Breast SPORE 11 Core Areas of Focus Education & Outreach –Forums & community groups that promote communication, education, and awareness between researchers, patient advocates, and the public Tissue Core –Review of the use of the tissue collected from breast cancer patients –Representation at Tissue/Outcomes Core Meetings Clinical Trials –Protocol/consent review & development –I-SPY II Trial Policy Issues & Strategic Planning –Discussions with investigators involving ethics in research and future directions Advocacy Core