April

 Ensure all counselors are familiar with the pros and cons of participation in clinical trials  Ensure all counselors are familiar with patient requirements and schedules that are involved in the I-SPY 2 clinical trial  Provide counselors with suggestions for assisting I-SPY 2 patients  Ensure that counselors are familiar with appropriate I-SPY 2 expectations and record keeping procedures 2

3  The what and why of clinical trials  Introduction to I-SPY 2  I-SPY 2 patient support materials  Supporting patients undergoing neoadjuvant treatment  Network of Strength processes for I-SPY 2  Q & A and Summary 

 Research that carefully tests new ways to prevent, diagnose, or treat diseases like breast cancer  A study that includes only patients who choose to participate  An important way to advance science and develop better therapies for patients with diseases similar to those being treated in the trial  A method whereby patients are randomly assigned to receive standard treatment OR standard treatment plus an investigational drug 4

ProsCons  Treatment by a team of first rate clinicians at a comprehensive cancer center  More, and possibly better, attention  Potential to receive a new, beneficial drug  Opportunity to contribute to the advancement of science  Possible need to travel farther for treatment  Possibility of receiving a new drug that provides no additional benefit but may add side effects  Additional visits to the clinic and additional laboratory procedures 5

 Enable advancement of science  Provide a good option for patients seeking treatment  Are not right for everyone  Should inform patients about pros and cons  Never pressure patients to participate 6

◦ From NCI: al-trials-education-series al-trials-education-series ◦ From Dana Farber: info/default.html info/default.html ◦ From ACS: 6_3_Clinical_Trials_-_Patient_Participation.asp 6_3_Clinical_Trials_-_Patient_Participation.asp 7

8  The what and why of clinical trials  Introduction to I-SPY 2  I-SPY 2 patient support materials  Supporting patients undergoing neoadjuvant treatment  Network of Strength processes for I-SPY 2  Q & A and Summary 

The purpose of I-SPY 2 is to learn:  Whether patients with breast cancer benefit from adding an investigational drug to standard chemotherapy  Which investigational drugs are most likely to work for which subtypes of breast cancer, based on biomarkers  What changes these drugs make on tumor biomarkers and MRIs 9

Women who:  Are newly diagnosed with stage II or III breast cancer  Have a tumor equal to or greater than 2.5cm  Have a biomarker profile indicating a high risk of recurrence with standard treatment, based on: ◦ ER/PR status ◦ HER2 status ◦ MammaPrint results 10

11 Recruit Patients Enroll Patients Treat Patients Support Patients Peer Counselors

Agree? Make Patients Aware of Trial Screening Consent Discussion Interest ? Eligible ? Done Yes No Non-Eligibility Discussion Decline Questionnaire Yes I-SPY 2 Brochure I-SPY 2 Patient Website; DVD 12

 Provides general description of I-SPY 2 ◦ Goals ◦ Patient schedule ◦ Risks and benefits ◦ Financial issues  Provides specific information about eligibility requirements and screening procedure  Does not provide specific information about drugs  Requests patient’s agreement to be screened 13

Randomize (Determine Treatment) Eligible ? Agree? Treatment Consent Discussion No Yes Non-Eligibility Discussion Decline Questionnaire No Yes I-SPY 2 Patient Website & DVD 14

 Follows patient randomization  Provides detailed description of I-SPY 2 ◦ Goals ◦ Patient schedule Specific drug side effects  Standard drugs (Taxol and AC) in treatment consent  Herceptin and experimental drugs in supplemental consent ◦ Risks and benefits ◦ Financial issues ◦ Withdrawal process  Requests patient’s agreement to be treated in I-SPY 2 15

 During treatment, informed consent patients are offered phone calls of support from a Network of Strength peer counselor; if interested, patients sign and return a pre- stamped request form.  Patients may, alternatively, note the phone number and call if and when they please. 16

Name: Address: Nancy L. Nixon Director--Contact Center Breast Cancer Network of Strength(r) 300 W. Adams St., Suite 430 Chicago, IL Peer Support Facing a cancer diagnosis can be traumatic and making treatment decisions can be challenging, including whether or not to participate in a clinical trial. Many women in your situation find it helpful to speak with someone who has already gone through this experience. The Breast Cancer Network of Strength (formerly Y-ME) was founded in 1978 to provide peer-to-peer support to meet the needs of newly diagnosed breast cancer patients. They run a 24-hour, 7-day a week Support Center ( ) that is staffed by trained and certified breast cancer survivors to provide emotional support, information, and help people affected by breast cancer. Spanish and English counselors are available to answer calls at all times, and interpreters are available for callers who are not English or Spanish speakers. This service is available to anyone at any time, even if you do not join the I-SPY 2 TRIAL. Are you enrolling in the I-SPY 2 TRIAL? If you are enrolling in the I-SPY 2 TRIAL, you can have a Breast Cancer Network of Strength counselor who has been trained to know about the trial assigned to you. She will call you and schedule regular calls, approximately once per month, as you are undergoing your treatment. The counselor can help you talk about the emotions you are feeling with your diagnosis and treatment, discover useful ways to cope, identify questions you have for your doctors, and help answer questions about I-SPY 2 study procedures. Just provide the following information, fold and place in the mail. Date: Patient’s Name: Preferred Phone Number: Call Time Preferences: Primary Language: Trial Site: Enrollment Date: Biomarker Profile: Treatment Arm: To be completed by Network of Strength Staff Network of Strength Counselor: Assignment Date: 17

Screening 18 Tissue - MRI Blood Draw MRI Biopsy Blood Draw MUGA/Echo PET/CT Scan Treatment Consent MRI Biopsy Blood Draw Taxol +/- Herceptin +/- New Drug (12 weekly cycles) AC (4 monthly cycles)

 Chemotherapy is given prior to surgery (neoadjuvant treatment).  Standard chemotherapy includes Taxol, AC, and Herceptin (if HER2+).  Surgery takes place approximately 6 months after the first treatment.  Hormonal treatment and/or radiation therapy is given after surgery to patients, if indicated. 19

 Three additional biopsies  Three additional MRIs  Investigational drugs—given to 80% of patients  Investigational drugs—given because they are expected to work for a patient’s specific type of breast cancer  Research drugs and procedures—paid for by trial sponsors, but patients or their insurers pay for standard treatment 20

- Shortly After Enrolled After Completion of Taxol Prior to Surgery After First Treatment Following Surgery 21

Tab 4Tab 6  I-SPY 2 Trial Site Contacts  I-SPY 2 Fact Sheet  I-SPY 2 Executive Summary  Nature Article  I-SPY 2 Press Release  I-SPY 2 Advocate FAQs  I-SPY 2 Patient Website Content  I-SPY 2 Overview Brochure  I-SPY 2 Patient DVD  NCI Taking Part in Cancer Treatment Research Studies  NCI Chemotherapy and You: Support for People With Cancer  NCI Adjuvant and Neoadjuvant Therapy for Breast Cancer  Agendia MammaPrint Patient Brochure 22

23  The what and why of clinical trials  Introduction to I-SPY 2  I-SPY 2 patient support materials  Supporting patient undergoing neoadjuvant treatment  Network of Strength processes for I-SPY 2  Q & A and Summary 

 Introductory brochure  Patient DVD  User friendly I-SPY 2 patient website  Other support provided by individual trial sites 24

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31  The what and why of clinical trials  Introduction to I-SPY 2  I-SPY 2 patient support materials  Supporting patients undergoing neoadjuvant treatment  Network of Strength processes for I-SPY 2  Q & A and Summary 

 Provide participants with an opportunity to discuss their diagnosis and treatment issues with trained peer counselors ◦ Validation of emotions and support for handling them ◦ Questions about the trial  Encourage participants to comply with trial requirements and raise concerns with their health care provider 32

IssuePotential Resolution  Neoadjuvant therapy  Multiple biopsies  Multiple MRIs  Investigational drugs 33

IssuePotential Resolution  Potential insurance concerns  Time, cost, and inconvenience of extra clinic visits  Distance to trial site  Change of doctor 34

IssuePotential Resolution 35

For all call: Check current status and discuss patient issues Check compliance and help patient articulate issues for health care provide Anticipate next steps of treatment Schedule next call - Shortly After Enrolled After Completion of Taxol Prior to Surgery After First Treatment Following Surgery 36

37  Ideal Time: Within one week of enrollment  Goals of Call ◦ Check current status and discuss patient issues ◦ Check compliance and assist patient to identify issues for health care providers ◦ Review key components of I-SPY 2 ◦ Remind patient of treatment team members and roles ◦ Suggest review of I-SPY 2 support material, if needed ◦ Anticipate next steps of treatment ◦ Schedule second call  Suggestions ◦

Caller Concerns  Wants to know more about MammaPrint test  Is having second thoughts about participating in a clinical trial—extra visits and being a “guinea pig”  Is concerned about neoadjuvant therapy Peer References  MammaPrint brochure and website: /75.php /75.php  “Taking Part in Cancer Treatment Research Studies” and I-SPY 2 DVD  “Adjuvant and Neoadjuvant Therapy for Breast Cancer” 38

Caller Concerns: Feeling anxious and a bit fearful of starting the clinical trial Peer Counselor Support  “Feeling anxious and fearful is common when starting a clinical trial.”  “It’s important to remember that you will be treated at a comprehensive cancer center and will receive standard treatment and possibly a new beneficial drug.”  “Those leading the clinical trial want you to do well and will monitor you very closely.” 39

 Divide into groups of three  Assign roles ◦ Patient ◦ Peer counselor ◦ Observer  Role play for about 6 minutes  Debrief with group members to discuss their feelings and observations  Rotate roles and scenarios, time permitting 40

41  Ideal Time: Within two weeks of first chemo treatment  Goals of Call ◦ Check current status and discuss patient issues ◦ Check compliance and assist patient to identify issues for health care providers ◦ Review of key components of I-SPY 2 ◦ Remind patient of treatment team members and roles ◦ Suggest review of I-SPY 2 support material, if needed ◦ Anticipate next steps of treatment ◦ Schedule third call  Suggestions ◦

42  Ideal Time: Between next to the last Taxane and second AC  Goals of Call ◦ Check current status and discuss patient issues ◦ Check compliance and assist patient to identify issues for health care providers ◦ Review key components of I-SPY 2 ◦ Remind patient of treatment team members and roles ◦ Suggest review of I-SPY 2 support material, if needed ◦ Anticipate next steps of treatment ◦ Schedule fourth call  Suggestions ◦

Caller Concerns  Patient worries that her cancer is not shrinking  Patient wonders why she needs AC when her scans are looking good Peer Counselor Support ‣Not Shrinking. Suggest that patient discuss her MRIs with her doctor; remind her that she still has more treatment and not all cancer reacts immediately to chemotherapy. ‣Shrinking. Remind her that chemo is meant to kill any cancer cells throughout her whole body, not just in her breast. AC is still standard of care, but some patients do forego it. She should discuss this with her doctor. 43

Caller Concern: S ide effects, such as nausea and joint pain, that might be the result of some chemo Peer Counselor Support Possible side effects of chemo can be scary; however, she should remember that many people have no, or just a few, side effects. Taxol and Herceptin may cause mild muscle pain and nausea The doctor can prescribe several medications that will help with symptoms. Recommend that she keep her clinical team informed of any side effects, ensuring that appropriate meds are given and enabling her to feel her best during the trial. 44

 Divide into groups of three  Assign roles ◦ Patient ◦ Peer counselor ◦ Observer  Role play for about 6 minutes  Debrief with group members to discuss their feelings and observations  Rotate roles and scenarios, time permitting 45

46  Ideal Time: About one week prior to surgery  Goals of Call ◦ Check current status and discuss patient issues ◦ Check compliance and assist patient to identify issues for health care providers ◦ Review key components of I-SPY 2 ◦ Remind patient of treatment team members and roles ◦ Suggest review of I-SPY 2 support material, if needed ◦ Anticipate next steps of treatment ◦ Schedule fifth call  Suggestions ◦

47  Ideal Time: About one week after surgery  Goals of Call ◦ Check current status and discuss patient issues ◦ Discuss outcome of surgery (e.g., pathological complete response—pCR) ◦ Discuss follow-up ◦ Discuss continuing concerns ◦ Discuss availability of future support  Suggestions ◦

Caller Concerns ‣Having second thoughts about not having had reconstructive surgery ‣Worrying about not having a pathological complete response (pCR) ‣Experiencing late side effects Peer Counselor Support ‣Reconstruction. Options and/or a recommendation for a consultation with a plastic surgeon can be discussed; reconstruction has no time limit. ‣pCR. Many patients do not have pCR but do very well, especially those whose tumor was ER+ and who haven’t started endocrine therapy. ‣Late Side Effects. Such fears are common; if something unusual persists, she should talk to her oncologist. 48

Caller Concern: Wants to know how to get answers to her ongoing concerns during the clinical trial Peer Counselor support ‣Get questions answered now and throughout the clinical trial. ‣Maintain an open conversation with the medical team. ‣Put together a list of questions for the doctor. ‣Search a few websites that offer a wealth of information on the clinical trial. 49

 Divide into groups of three  Assign roles ◦ Patient ◦ Peer counselor ◦ Observer  Role play for about 6 minutes  Debrief with group members to discuss their feelings and observations  Rotate roles and scenarios, time permitting 50

Caller Concern: Caller wants to know how to get answers to all her ongoing concerns during the clinical trial Peer Counselor support ‣Get questions answered now and throughout the clinical trial. ‣Maintain an open conversation with the medical team. ‣Put together a list of questions for the doctor. ‣Search a few websites that offer a wealth of information on the clinical trial. 51

52  The what and why of clinical trials  Introduction to I-SPY 2  I-SPY 2 patient support materials  Supporting patients undergoing neoadjuvant treatment  Network of Strength processes for I-SPY 2  Q & A and Summary 

 Getting assigned to new patients  Scheduling calls  Addressing additional patient concerns  Addressing additional peer counselor questions  Maintaining information in the Network of Strength Support Center  Participating in monthly conference calls 53

 During the treatment consent, patients will be provided with a “Network of Strength Counselor Request” ◦ If a patient fills out and returns the self- addressed/pre-stamped form, she will be assigned an I-SPY 2 peer counselor ◦ Patients who do not wish a specially assigned counselor may still call the hotline at any time (24x7)  Nancy Nixon assigns peer counselors  Peer counselors schedule calls with patients 54

Name: Address: Nancy L. Nixon Director--Contact Center Breast Cancer Network of Strength(r) 300 W. Adams St., Suite 430 Chicago, IL Peer Support Facing a cancer diagnosis can be traumatic and making treatment decisions can be challenging, including whether or not to participate in a clinical trial. Many women in your situation find it helpful to speak with someone who has already gone through this experience. The Breast Cancer Network of Strength (formerly Y-ME) was founded in 1978 to provide peer-to-peer support to meet the needs of newly diagnosed breast cancer patients. They run a 24-hour, 7-days a week Support Center ( ) that is staffed by trained and certified breast cancer survivors to provide emotional support, information and help people affected by breast cancer. Spanish and English counselors are available to answer calls at all times, and interpreters are available for callers who are not English or Spanish speakers. This service is available to anyone at any time, even if you do not join the I-SPY 2 TRIAL. Are you enrolling in the I-SPY 2 TRIAL? If you are enrolling in the I-SPY 2 TRIAL, you can have a Breast Cancer Network of Strength counselor who has been trained to know about the trial assigned to you. She will call you and schedule regular call, approximately once per month, as you are undergoing your treatment. The counselor can help you talk about the emotions you are feeling with your diagnosis and treatment, discover useful ways to coping, identify questions you have for your doctors, and help answer questions about I-SPY 2 study procedures. Just provide the following information, fold and place in the mail. Date: Patient’s Name: Preferred Phone Number: Call Time Preferences: Primary Language: Trial Site: Enrollment Date: Biomarker Profile: Treatment Arm: To be completed by Network of Strength Staff Network of Strength Counselor: Assignment Date: 55

SituationAppropriate Response  Patient has questions about I-SPY 2 or other concerns that you cannot address  You have questions about how best to support patients in I-SPY 2  You have questions about logistics  Tell her to talk to or raise these issues with her health care provider  Contact Bev Parker (630)  Contact Nancy Nixon th.org (312) th.org 56

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69  The what and why of clinical trials  Introduction to I-SPY 2  I-SPY 2 patient support materials  Supporting patients undergoing neoadjuvant treatment  Network of Strength processes for I-SPY 2  Q & A and Summary 

70 “The only dumb question is the one not asked.”