Encouraging, Educating and Empowering By Sharing My Metastatic Breast Cancer Story

Update, June 21, 2016: Sarita Joy Jordan passed away on June 19, 2016. Beloved by so many, she was a member of Living Beyond Breast Cancer’s 2015 inaugural Hear My Voice: Metastatic Breast Cancer Outreach Program, and, prior to that served on LBBC’s Breast Cancer Helpline and volunteered at many LBBC programs. Sarita spoke frequently to those in her local Philadelphia community including the media, medical students, and the general public. She used social media to reach a broader community through blogs and a Facebook page she created. An information seeker by nature, Sarita attended many national and local conferences gathering knowledge that she then shared with others.

The LBBC staff wanted to reshare this blog post Sarita wrote last year for the Beyond The Breast Campaign. It provides a sense of what a remarkable person she was and how she lived her life with joy and commitment. We will miss her.


Sarita Joy Jordan

In December 2005, I attended my first educational conference about breast cancer. The topic was about fertility in young women while going through a breast cancer diagnosis and treatment. I remember it like it was yesterday. I sat there and just listened to all that was going on around me. I had just had chemotherapy treatment that week and wasn’t feeling 100%.

There was a guest speaker who told her story. Her journey through breast cancer was incredible. Through all the surgeries and treatments she endured displayed an insurmountable amount of strength. I remember sitting there thinking, “I don’t have a story like that, WOW!” I had just started my journey and was in a fog as to what living beyond breast cancer should look like because I was a “newbie” in the fight.

11935020_10207730658931621_429639499760256324_nAs I continued on my path, growing through each step of the process, I began to think maybe I do have a story. There are so many things that go on that are ‘not so pretty in pink’, that no one prepared me for. At each conference I attended, trying to figure out my new normal, I learned something new to add to my zest for life. Somewhere in this process I began to blog from time to time and shared my story with almost toanybody who would listen. I didn’t want anyone to have to experience the depression, fear, anger, loss friendships due to their inability to cope, and loneliness. These are the things that all cancer patients go through behind closed doors. Eventually I was able to retire from my job and define my purpose and eagerness to help others by becoming a breast cancer advocate. I learned how to tell my story to encourage, educate and empower others to fight through a breast cancer diagnosis.

SO, I was asked, why do I tell my story? Honestly, I had to think: Why do I tell my story? There are several reasons. I choose to share my story so that others don’t feel they are alone. I tell my story because I am an African-American and my community needs to be able to relate to the messenger. I tell my story because I was stage I at my initial diagnosis and now LIVING with stage IV. I tell my story because I will celebrate 10 years of survival this month and I know this gives other women hope. I tell my story because I’ve learned that little money is spent on research for metastatic breast cancer and I’m running out of time to have my voice heard. This is why I am so grateful to be a Hear My Voice Outreach Volunteer with LBBC: to participate in community events and advocacy for metastatic disease. I tell my story for those that are no longer able to tell theirs.

12002748_10207917950653797_566816831184771998_nLastly, I tell my story for my children. They will always be able to access who their mom is as a person who truly cares, as a survivor, as a fighter, as a friend, as an advocate and someone who has used her own journey to try to save lives. In closing, I realize I do have a story. Each and every on of us does. Sharing is caring!

The New Normal

Karyn Williams participated in Writing the Journey, our writing workshop series for people affected by breast cancer. This poem, “The New Normal,” was written during the workshop. Read her poems “The Bridge” and “Life to Live” on our blog.

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Now there are days filled with wonder.
I wonder how long I have left to live,
I wonder what on earth to do,
I wonder if I’m right,
I wonder what the future holds.
Fearful,
the new normal.

I wonder if there really is a cure…
I wonder why they would hide it if there is.
I wonder if I should walk more, run more,
I wonder if I should grow kale.
Overthinking,
the new normal.

I wonder if I should wish upon a star,
I wonder if dreams do come true.
I wonder about life and meaning.
I wonder what to believe, who to believe.
Faith, hope, doubt,
the new normal.


Karyn Williams, 59, is a mother of four children and has two grandchildren (and another on the way). She lives in Australia with her loving husband. Karyn was diagnosed with early-stage breast cancer in 2008. In 2014, she learned she had metastatic breast cancer in her lungs, liver, brain and spine. Karyn has been pleased to find support through online communities like those offered through Living Beyond Breast Cancer.

Measuring What is Important to Patients in Clinical Trials: Precision Patient Reported Outcome (PRO) Assessments

Patty Spears, Research Patient Advocate and program manager of Cancer Information & Support Network, wrote this post about the patient voice in outcome assessments for Breast Cancer Clinical Trials Matter to You.

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I have been interested in how clinical trials are developed and conducted since my diagnosis and treatment of breast cancer in 1999. My diagnosis led me to participate in two clinical trials, which was an easy decision for me. I have been involved in basic research for the past 30 years studying microbial pathogenesis, so participating in a clinical research study was a natural choice. However, this is not the case with most cancer patients.

Having been a patient advocate for more than 10 years, I have had multiple opportunities to be involved in the development and conduct of clinical trials at both the local and national level. During this time there have been many changes in the way trials are conducted, and changes in the expectation of patients who volunteer to participate in the trials. Patients today are more involved in clinical research and in their own healthcare than in the past. Patients today want to have a voice. And they need information from other patients about their experiences on clinical trials to make informed decisions about their own current treatments. To make informed decisions, patients need to have information about benefits and harms that are important to them. Assessing potential benefits and harms is very subjective and needs to be done consistently and reliably to accurately predict what is important to patients.

One way to measure benefits and harms is by using Patient Reported Outcome (PRO) assessments through the administration of questionnaires answered directly by the patient. PROs are defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” The incorporation of PROs in clinical trials measures not only what is the matter with the patient, but also measures what matters to the patient1.

There not only needs to be a shift in what is being measured and reported by patients, there also needs to be an effort to make the questionnaires more acceptable to patients to complete during clinical trials. I have participated in a clinical trial that used questionnaires (PROs) and I have also asked many other patients about their experiences and feelings about questionnaires regarding barriers and incentives to completing them including their acceptability of how they are administered.

Patients want to understand how the information they provide will be used to inform future patients. Asking the same question multiple times (redundant questions), which is likely to occur when multiple questionnaires are packaged into one trial, is irritating to patients. This was the case in the questionnaires I completed. I would actually go back to find what I answered on the previous page and I wondered whether they were actually testing me to see if my answers were consistent. This does not build trust with patients.

There were also some barriers and acceptability issues to completing questionnaires including the time it takes to fill them out, the number of questions on each questionnaire and how often questionnaires are given to the patient. There is not one answer, there is not a perfect number of questions to ask, and it will depend on the trial and the predetermined PRO endpoint. For example, a questionnaire with fewer questions may be able to be given more often and may capture trends in how patients are feeling and functioning immediately after therapy and before their next appointment, which may provide very useful information for future patients. The longer questionnaires are best given less frequently but can still add value to capturing the entire patient experience. With the move toward electronic PRO assessments there are more opportunities to incorporate PROs into all clinical trials in ways that are acceptable to patients and provide information that is important to future patients.

It is time to transform PROs to be more meaningful by measuring what is important to patients and to ensure the information is reported back to patients and clinicians to guide informed decision-making.

What is needed to ensure PROs are in all clinical trials and that they truly measure what is important to patients? Patients need to be involved in informing which questions should be asked based upon specific disease condition and therapies being tested. Every trial is unique and will require different PRO assessment strategies so that the questions asked are relevant to that specific situation. Patient relevant endpoints need to be identified early in trial development so the appropriate questions can be asked in the clinical trail. The purpose or endpoint based upon the PRO assessment needs to measure what is important to patients and should guide what questions are asked and how often they are asked. The clinical trial needs to be conducted and the PRO measurements collected with the same rigor as other measurements (e.g., imaging) within the clinical trial.

How do you develop targeted, precision PRO assessments for patients?

Ask patients to report what matters to them

  • Make PRO measurements acceptable to patients to complete
  • Make PRO measurements an important part of the trial with well-defined purpose and use
  • Make the PRO endpoints meaningful to patients
  • Make the PRO information available to patients

In the end, it is about developing Precision PRO Assessments: asking the right question, at the right time, in the right way, so that what is being measured is important to patients.
1Accelerating Anticancer Agent Development and Validation, 2015. Patient and Stakeholder Engagement in Risk/Benefit Decision Making in Cancer Drug Development, Sandra Finestone

2Paul G. Kluetz, Ashley Slagle, Elektra J. Papadopoulos, Laura Lee Johnson, Martha Donoghue, Virginia E. Kwitkowski,Wen-Hung Chen, Rajeshwari Sridhara, Ann T. Farrell, Patricia Keegan, Geoffrey Kim, and Richard Pazdur Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms, Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035

Clinical Trials and Hurdles for Men With Breast Cancer

Diagnosed with stage II ER-positive breast cancer in 2005, Lee Giller, of Akron, Ohio, learned in Fall 2012 that the cancer returned and was stage IV. Lee and his wife, Kathy, discuss his experience navigating clinical trials, participating in the BROCADE study and more in this Q&A for Breast Cancer Trials Matter to You.

UPDATE, 6/4/16: An earlier version of this post contained errors regarding Lee’s information about the BROCADE study and cancer progression. This Q&A has been revised with the correct information.  

Q: How did you find out about the BROCADE study?

LEE:

My then-doctor in Boston told us about the study and referred us to an oncologist closer to home in Cleveland, Ohio. She informed us about a  phase II randomized blind study for women and men with metastatic breast cancer that’s BRCA-positive. The trial was evaluating the efficacy of a new PARP inhibitor called Veliparib. The doctor made arrangements for us to proceed with the nearest trial, which was in Pittsburgh. Thankfully, I fit the trial’s criteria. Being male, I’m not always eligible for some breast cancer clinical trials that are geared strictly for women.

Q: Did you have any concerns about participating? If so, what were they, and what helped ease those concerns?

LEE:

I really didn’t – we had cleared it with three very qualified doctors. I felt the trial was tailor-made for me and my best shot at that point. I really didn’t think a lot about it being a clinical trial. 

KATHY:

Unlike Lee, who always has an amazingly positive attitude, I was under the impression that if someone does a clinical trial, that means there’s nothing left for them to try. That worried me. I looked at the study as our last best hope.

Through this experience, I’ve since learned that this is not the case. If you participate in a trial, you have the benefit of getting the best standard care treatment even if you don’t get the new cutting-edge drug. When Lee had his recurrence with metastatic disease he had symptoms like coughing and breathing problems. Ultimately the doctors felt it was important that he had chemotherapy to help alleviate these symptoms, and chemo was part of this study.

Q: Can you describe your experience in the trial?

LEE:

I had 14 rounds of treatment. It was the kind of chemotherapy reaction where I’d get the infusion, it’d hit me about two days later and then I’d have three-four days of feeling lousy. Then by the time I’d start to have a really good week, it’d have to go through it all over again. It was difficult.

I eventually had toxicity with the carboplatin, which happens around the eighth round for most participants. I lasted 14 rounds before I had an allergic reaction that ended the study for me.

KATHY:

The clinical trial was very effective in alleviating Lee’s symptoms as well as eliminating much of the cancer.  Prior to the trial, the breast cancer had metastasized to his liver, lungs and bones.  After the trial ended, his scans showed “resolution” of the cancer in those areas.  Later, his oncologist gained permission for Lee to try the PARP inhibitor as a single-agent by requesting compassionate care use from the pharmaceutical company.  Unfortunately, severe side effects prohibited Lee from staying on that drug for very long.

Q: Can you comment on your experience finding and/or participating in a research study as a man with breast cancer?

LEE:

I had a hard time being a man with breast cancer in the beginning. I’ve found that because I’m a man with breast cancer and it’s pretty rare, providers and hospital workers get to know me because I stand out. I’ve embraced it a little as a positive thing.

Since I was first diagnosed in 2005, I’ve had some good conversations with other male patients I’ve come to meet along the way. It’s always given me a great deal of satisfaction to be able to get the word out and advocate for other men with breast cancer.
KATHY:

We’ve come across trial options where Lee couldn’t participate because he’s a man. It makes you wonder what opportunities he’s missing out on because of that.

For example, the description of palbociclib (Ibrance)  which he is taking now, is designed for postmenopausal women. When it was first prescribed, the insurance company denied covering it. The claim was appealed and is now covered, but we had to jump through some hoops. It’s something that needs to be addressed, and thankfully groups like the Male Breast Cancer Coalition and Living Beyond Breast Cancer are helping to do that.

LEE:

Thankfully, I have a great advocate in Kathy, who is relentless in dealing with the insurance companies.

Q:What tips would you share with other men with breast cancer who are considering clinical trials?
LEE:

Always try to find the best doctors and make sure you trust them. Do your homework, too, but if you can get two good opinions and those providers agree on a treatment, clinical or not, trust them and follow their advice.

KATHY:

Weigh your options. Look at all of them closely. And know that clinical trials don’t mean “last resort.”

Read more about Lee and other men affected by breast cancer on Male Breast Cancer Coalition’s website.


Breast Cancer Clinical Trials Matter to You is sponsored by

A Tisket a Tasket…Trials Now Come in “Baskets”

Elly Cohen, PhD, program director of BreastCancerTrials.org, wrote this post for Breast Cancer Clinical Trials Matter to You about a recent innovation in cancer research: basket trials.

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Basket trials (also known as bucket trials) are a new category of clinical trials that demonstrate the emerging importance of precision medicine in cancer care. They are distinguished from traditional clinical trials in that they enroll patients across multiple cancer types by focusing on a tumor’s mutation status rather than its primary site of origin. Basket trials are made possible by our rapidly accruing knowledge about molecular pathways regulating cell growth, cancer-producing mutations to these pathways, and therapies that target these mutations.

“NCI-MPACT: Molecular Profiling-Based Assignment of Cancer Therapy for Patients With Advanced Solid Tumors” is an example of a basket trial that is open to patients with breast cancer and other solid tumors that have progressed on prior therapy. As is typical of a basket trial, patients are first evaluated in a screening phase during which time their tumors are sent to a laboratory for genetic sequencing. Only patients with one of the four mutations under study in NCI-MPACT continue to the treatment phase of the study. After an additional eligibility review, patients are grouped by mutation status and within each group, randomized to receive either a targeted or a non-targeted therapy. In NCI-MPACT, four different mutation/targeted therapy combinations are being studied.

The NCI-MATCH (Molecular Analysis for Therapy Choice) trial is another basket study enrolling breast cancer patients. Initially opened in mid-August 2015 with 10 treatment groups, its accrual far exceeded expectations. This caused delays in tumor testing that impeded the flow of patients from screening to treatment. NCI-MATCH re-opened for patient enrollment to its screening phase in May 2016 after being temporarily closed for an interim analysis. The reopened trial will expand to 24 arms and is expected to enroll 5000 patients at 796 sites across the country. To address screening delays, investigators will add laboratory resources to reduce the bottleneck between screening and treatment. To learn more about NCI-MATCH, go to cancer.gov/nci-match.

As is the case with NCI-Match, an important benefit to the basket cell design is that it allows investigators to include patients with uncommon cancer types in clinical trials if they share common mutations. This will become increasingly more important as patients, even those with breast cancer or other prevalent solid tumors, become increasingly subdivided by mutation status. Without the basket trials, the resulting patient populations might be too small to determine meaningful outcomes within traditional randomized clinical trials.

Given the excitement and interest in basket trials, it’s hard to believe that the first publication of a basket study appeared in the New England Journal of Medicine in August 2015. Conducted by investigators at Memorial Sloan-Kettering, it evaluated vemurafenib, a drug that had been proven to treat BRAFV600-mutated melanoma tumors, in non-melanoma tumors with a BRAFV600 mutation. People with lung, colorectal, and ovarian cancers as well as those with rare diseases, such as Erdheim-Chester disease were included in the study. The study showed effectivness of vemurafenib for lung cancer and Erdehim-Chester, but more importantly, established the basket trials concept as a new and important model of clinical trial design.

Currently, basket trials are only available for patients with metastatic cancer.If you are interested in learning more about basket trials, BreastCancerTrials.org has an updated list of basket trials that are registered in ClinicalTrials.gov or Cancer.gov and actively recruiting breast cancer patients. If you contact a research site, you may want to inquire about the time you might expect to wait between the screening and treatment phases of the trial.

In summary, basket trials offer a new and exciting way to evaluate targeted therapies across cancers and to accelerate their availability in the clinic.  By focusing on the genetic properties of tumors, they will help to make precision medicine a reality for patients in cancer care.

 


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Raising Awareness of Clinical Trial Options for African-American Women

Averl Anderson, 62, is a minister with Greater Emmanuel Temple in Buffalo, NY, and a chaplain at Roswell Park Cancer Institute. She was diagnosed with stage III triple-negative breast cancer in 2009. Averl did a Q&A for Breast Cancer Clinical Trials Matter to You, to discuss advocacy for clinical trial participation among African-American women, her experience in a trial for bevacizumab (Avastin), and more. 

Averl_for blogQ: How did you learn about the clinical trial you joined?

Averl: My oncologist mentioned it in 2010 as a treatment option for me in combination with chemotherapy.

It was a double-blind study, but I eventually learned I was in the treatment group receiving Avastin.

Q: What was it like being in the trial?

Averl: I was in the trial for about five months. The first two months was every two weeks, and for the last four months it was once a week for three months.

I experienced side effects like neuropathy, or tingling in my feet, hair loss and changes in my finger nails. Thankfully, I didn’t experience some of the severe side effects like vomiting and diarrhea.

The cancer had responded well to the treatment. The FDA withdrew approval for Avastin in November 2011, saying it was not effective. I thought that was unfortunate because I’m still free of cancer, so I feel the treatment was at least effective for me.

Q: What were some of the concerns you had before participating in the study?

Averl: I was little apprehensive when my doctor first brought up because my mind immediately went to the Tuskegee experiment and exploitative research.I also worried about experiencing extreme side effects.

My doctor had a clinical trial nurse at the Roswell Park Cancer Institute come talk to me and answer the questions I had. She gave me information, I took home and went over it with my family, and later felt reassured enough to agree to join the trial.

Q: What do you think is the biggest hurdle to clinical trials participation?

Averl: Mistrust. Culturally, some people have experiences that make them extra skeptical about clinical trials.

Broadly speaking, if you look at the television commercials for certain medicines, they list all of these severe side effects. For some people, if that’s what you experience with FDA-approved medicine, what will happen when you take a drug that’s still being studied?

Q: How can breast cancer advocates help build trust about trials?

Averl: Peer advocates. It’s very effective to have someone who’s been through a clinical trial stand in front of you and tell you all about it.

I speak to a lot of focus groups and church groups about my experience. I worked with the Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum as a spokesperson for the I’m In campaign. I’d often speak to minority women about clinical trials because they are the ones that don’t always participate. Continue reading

Every Minute Matters: Enrolling in Studies While Living With Metastatic Breast Cancer

Camille Scheel is a Living Beyond Breast Cancer Hear My Voice Outreach Volunteer and author of Camp Chemo: Postcards Home from Metastatic Breast Cancer. For Breast Cancer Clinical Trials Matter to You, Camille shares her experience participating in a clinical trial for PARP Inhibitors.

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Two months ago, I was literally jumping up and down with joy. I learned I had been accepted into a clinical trial! It’s what I’d been wanting for such a long time. More than a year ago I heard about the trial and switched oncologists hoping to get into this very trial.

The trial is for a class of drugs called PARP Inhibitors. These drugs work for individuals with BRCA mutations. Years ago I started reading about PARP Inhibitors, and knowing I was BRCA positive, I thought this drug would work for me. When I first tried to get into the trial I didn’t fit the criteria. The problem was I’d received too many cytotoxic treatments already. More than a year later, my oncologist told me the criteria had changed, and now I qualified for the EMBRACA study and the drug I’m taking is Talazoparib.  This is a phase III clinical trial of a PARP Inhibitor. Phase III means the drug has already been studied in humans for safety, efficacy, and now is being compared to existing treatments.

My geneticist was the first to tell me about PARP Inhibitors. So I started Googling them. Truth be told it kind of became stalking – I was seeking any information I could about PARP Inhibitors, including trials. When I learned from ClinicalTrials.gov that an oncologist in my practice was involved in a PARP study, I switched oncologists in hopes of getting into the trial. When I didn’t qualify based on the number of cytotoxins I’d already received, I was so upset. But a year later, the study investigators were not getting enough enrollment, which made them loosen up their criteria, allowing me to qualify.

This is my first clinical trial and so far the study drug is working for me. My disease is stable. The side effects are minimal compared with other MBC treatments I’ve received. Given the chance to participate in another trial, I would do so in a heartbeat. Even if I were randomized to the control (standard of care) group, I’d still participate because it’s so important for studies to be completed in a timely manner in order to get treatments to the market faster. Living with mets, we don’t have much time, so every minute matters. Continue reading