Courtney Hudson, CEO and Co-Founder of EmergingMed, explains the latest clinical trials for metastatic breast cancer and how to find them. Learn how to identify appropriate clinical trials, determine eligibility and "must ask" questions for the researchers, find strategies to determine your best options, and figure out which questions to ask when making your decisions.

1. Courtney Hudson, CEO & Founder, EmergingMedJune 26, 2017
FACT VS FICTION:
CLINICAL TRIALS FOR OVARIAN CANCER
FACT vs. FICTION
CLINICAL TRIALS FOR BREAST CANCER

2. Agenda
1. How to search for clinical trials?
2. What’s out there?
3. About targeted therapies & tumor
profiling
4. Considerations for phase I clinical trials
5. Discussion & questions
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www.ShareCancerSupport.org 1.877.769.4832

3. Today’s goal is to empower you with information
and a strategy to explore and access breast
cancer clinical trials
Create a profile team up with a Navigator
How to search for trials?3
www.ShareCancerSupport.org 1.877.769.4832

4. SHARE Clinical Trial Matching Service
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www.ShareCancerSupport.org 1.877.769.4832
1) Complete profile
2) Update profile
3) Review matches with
Clinical Trial Navigator
4) Talk to trial site(s)
5) Discuss with your doctor

5. Never forget...
¨ Clinical trials may or may not be right for you
v Standard care vs. clinical trial vs. off label treatment vs. watch & wait
¨ Explore clinical trials each time you make a treatment
decision
¨ You are NEVER required to enroll in a clinical trial
¨ You are NEVER required to remain in a clinical trial
after you enroll
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www.ShareCancerSupport.org 1.877.769.4832

6. Clinical trials measure, measure, measure
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LESSONS Childhood Leukemia
LEARNED Breast Cancer– BMT & HDC
¨ Clinical trials explore risk/benefit of new therapies:
v New drug OR combination OR dosage/sequence
¨ Is experimental therapy better/worse vs. standard placebo
¨ Phases: I, II, III have become I/II, II, II/III, etc.
¨ Eligibility:
v Diagnosis, stage, treatment history
v And now tumor biomarkers…Tomorrow?
¨ Interim analysis

7. Notes
Clinical trials expect you to receive
standard of care (vs. off label)
Narrow window of time to enroll
What’s out there for metastatic breast
cancer treatment trials? as of 6/23/2017
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www.ShareCancerSupport.org 1.877.769.4832

8. Ø 50 unique drugs
Ø 25 targeted agents (hitting 40 alterations)
Ø 16 chemotherapies
Ø 9 hormonal therapies
Ø 2 immunotherapies target PD1 and PDL1
261 studies for metastatic breast cancer
www.ShareCancerSupport.org 1.877.769.4832

9. Clinical trials offered at all points
(newly diagnosed --> many treatments)
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10. About targeted therapies & genomic profiling
¨ Identify biomarkers or genomic alterations specific to
your tumor
¨ May or may not point you to a clinical trial today
¨ May provide information useful to you tomorrow
v Check back periodically for new research and targeted
agents specific to your tumor’s molecular or genetic profile
v Big question: do tumor’s change over time?
www.ShareCancerSupport.org 1.877.769.4832
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11. Ø Phase I trials are the first time a new therapy,
a new combination, or a new dosage schedule
is offered to patients
Ø Hundreds of new targeted therapies and
immunotherapies are entering Phase I trials
Ø These new opportunities raise new questions
Considerations for Phase I Trials11
www.ShareCancerSupport.org 1.877.769.4832

12. Phase I, first-in-human trials & targeted therapies
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¨ Anti-cancer activity is now a goal in Phase I trials
v Safety &maximum dose used to be only focus
¨ 70% of all agents in Phase I move on to Phase II
v In 2000, only 10% moved on to Phase II trials
¨ Over 700 new agents in Phase I cancer studies today
v Only 45 specifically mention ovarian cancer
v Look for roll over studies: Phase I/II or II/III
v May need to become patient of the investigator to get enrolled
in a Phase I trial (limited openings, limited sites)
¨ Always ask: how many patients have had the new therapy before
you in a Phase I study (none? 1? 10? 100?)
www.ShareCancerSupport.org 1.877.769.4832

13. Courtney Hudson
CEO & Founder, EmergingMed
chudson@emergingmed.com
To search for trials and get registered:
www.ShareCancerSupport.org
1.877.769.4832
Thank you and good luck13