Clinical Trials for Metastatic Breast Cancer

Courtney Hudson, CEO & Founder, EmergingMed June 26, 2017

FACT VS FICTION:CLINICAL TRIALS FOR OVARIAN CANCER

FACT vs. FICTIONCLINICAL TRIALS FOR BREAST CANCER

Agenda

1. How to search for clinical trials?2. What’s out there?3. About targeted therapies & tumor

profiling4. Considerations for phase I clinical trials5. Discussion & questions

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www.ShareCancerSupport.org 1.877.769.4832

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


SHARE Clinical Trial Matching Service4


1) Complete profile2) Update profile

3) Review matches with Clinical Trial Navigator

4) Talk to trial site(s)

5) Discuss with your doctor

Never forget...

¨ Clinical trials may or may not be right for youv 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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Clinical trials measure, measure, measure6

LESSONS Childhood LeukemiaLEARNED 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 historyv And now tumor biomarkers…Tomorrow?

¨ Interim analysis

NotesClinical 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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Ø 50 unique drugsØ 25 targeted agents (hitting 40 alterations)Ø 16 chemotherapiesØ 9 hormonal therapies Ø 2 immunotherapies target PD1 and PDL1

261 studies for metastatic breast cancer


Clinical trials offered at all points (newly diagnosed --> many treatments)

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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?


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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


Phase I, first-in-human trials & targeted therapies12

¨ Anti-cancer activity is now a goal in Phase I trialsv 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 todayv Only 45 specifically mention ovarian cancerv Look for roll over studies: Phase I/II or II/IIIv 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?)


Courtney Hudson CEO & Founder, EmergingMed

[email protected]

To search for trials and get registered:www.ShareCancerSupport.org

1.877.769.4832

Thank you and good luck13

Clinical Trials for Metastatic Breast Cancer

Healthcare

Transcript of Clinical Trials for Metastatic Breast Cancer