Clinical Trials: Special Stage IV Search Engine, a great book and more

See Metastatic Trial Search

 

Are you looking for a metastatic breast cancer clinical trial? A new search engine makes it easy to quickly identify trials appropriate to your situation. The Metastatic Trial Search , powered by BreastCancerTrials.org, also translates the trial descriptions into plain English.

Although I am not currently looking for a trial, I was curious to see what a search would yield. I filled out the required engine fields (only five). The results returned 180 possibilities. I quickly scanned through the listings–and I found a couple I will keep on my radar. Why not take a look? Just click here: Metastatic Trial Search

Another valuable resource is this book, Cancer Clinical Trials by Tomasz M. Beer, M.D.  and Larry W. Axmaker, Ed.D. I found this 160-page soft cover book at my local library. I was surprised, because I live in a small town and the selection of cancer books is limited. I also wondered if the authors would have enough material for a book-length manuscript. It turns out they did!

This is a great book–very easy to read and the reader can easily browse through the chapters to find the material of greatest interest to him or her. The book is divided  into four parts: Cancer and Cancer Treatment Basics, What Are Clinical Trials and How Are They Organized, Deciding Whether to Participate in a Clinical Trial, Medical Treatment of Cancer Now and in the Future.

Although I was familiar with some of the material, there was quite a lot I didn’t know. I knew some of the history behind the evolution of the clinical trial system, but I came away knowing a lot more. I also appreciated the chapter on drugs currently in testing. Categories of chemotherapy drugs include antimetabolites, alkylating agents, DNA cross-linking derivatives, antitumor antibiotics, miotic inhibitors. Hormonal agents are also covered: testosterone and estrogen lowering drugs, hormone blocking drugs and testosterone conversion/activation blockers. But wait, there’s more: small-molecule targeted drugs, monoclonal antibodies, immunotherapy, differentiation therapy and gene therapy. Obviously, not all of these drugs have application to metastatic breast cancer but I appreciated the clear explanation of what they are and how they work.

You can read an excerpt from “Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials” here.

While you cannot know the results of a clinical trial that has not been completed, it’s important to thoroughly understand why the trial is being conducted (the hypothesis) and how it’s going to be conducted (the experiment). You’ll also want to know how the clinical trial might benefit you: what is the expected—or hoped for—result. We will help you learn to ask the right questions of the right people to get these answers more quickly.–Dr. Tom Beer and Larry W. Axmaker

 

Cancer Clinical Trials Cover Final

–-Katherine O’Brien, August 2016

Notes for Those Newly Diagnosed With Metastatic Breast Cancer

Learning you have metastatic breast cancer can unleash a tsunami of emotions. Fear, panic, anxiety and anger are just a smattering of common responses. How can you deal with these feelings?

 

 

 Living Beyond Breast Cancer (LBBC) and MBCN have worked together to produce a  Guide for the Newly Diagnosed. See http://www.lbbc.org/get-support/print/guides-to-understanding/metastatic-breast-cancer-series-guide-newly-diagnosed

 

Talk to your oncologist--he or she may prescribe Ativan or other anti anxiety medications. Many treatment centers also have counselors on staff who specialize in helping those dealing with a cancer diagnosis. Ask if your center has a support group for metastatic breast cancer patients. Your oncologist also may be able to connect you with someone dealing with a similar diagnosis. Oncologists–like all medical professionals–must respect privacy laws.

 

If your doctor can’t suggest a local contact, you can reach out to a peer matching program and/or metastatic breast cancer hotline.

 

Here are several to check out:
SHARE hotline and phone support groups: http://www.sharecancersupport.org/share-new/support/groups/#metastatic

Living Beyond Breast Cancer helpline and other resources: http://www.lbbc.org/node/1578

Young Survival Coalition SurvivorLink is here: https://www.youngsurvival.org/survivorlink

 

Support Connection provides emotional, social and educational support here: http://supportconnection.org/contact-us-for-support/

 

BreastCancer.org has excellent information as well as  a dedicated Stage IV discussion forum. Here you will find others with MBC  https://community.breastcancer.org/forum/8

 

BCMets was among the first online forums for people living  with metastatic breast cancer:https://www.bcmets.org

 

Inspire.com hosts an Advanced Breast Cancer board: https://www.inspire.com/groups/advanced-breast-cancer/

Most people are familiar with early-stage breast cancer. Just what is metastatic breast cancer? Here is a concise overview:

 http://www.uptodate.com/contents/treatment-of-metastatic-breast-cancer-beyond-the-basics

…and here: https://medium.com/@ihatebreastcanc/metastatic-breast-cancer-the-missing-manual-from-a-stage-iv-patient-f8420a5a817d#.spajn14ks

NCCN Guidelines for Stage IV breast cancer treatment can be found here: http://www.nccn.org/patients/guidelines/stage_iv_breast/files/assets/common/downloads/files/stage_IV_breast.pdf   ( This PDF was issued in 2014; several new drugs have come out in the interim.)

BreastCancer.org has a detailed guide on understanding your pathology report: http://www.breastcancer.org/Images/Pathology_Report_Bro_V14_FINAL_tcm8-333315.pdf

How do you find an oncologist? You can ask your primary care doctor for a referral. Also: consider working with an NCI designated cancer center. Here  is a list: http://www.cancer.gov/research/nci-role/cancer-centers/find

Receiving the NCI-designation places cancer centers among the top 4 percent of the approximately 1500 cancer centers in the United States. More here: https://en.wikipedia.org/wiki/NCI-designated_Cancer_Center

 

Finally, we urge both the newly diagnosed and “veteran” patients to watch

Dr. Don Dizon’s EXCELLENT presentation from MBCN’s 2013 national conference: https://www.youtube.com/watch?v=5RKCGEpk2po

Dr. Dizon’s PRO approach (Pragamatic, Realistic and Optimistic) resonates with patients. Hopefully after watching this video you will feel informed, uplifted and empowered!

A Wake Up Call for Young People With Metastatic Breast Cancer…And All of Us

By Katherine O”Brien, Secretary and PR Chair, MBCN

Do you remember “Love Story?” Oliver Barrett IV (Ryan O’Neal) and Jennifer Cavilleri (Ali McGraw) are the improbable lovers who defy parental disapproval and get married.

The only way to be surrounded by more sap would be to visit Vermont during the peak months of maple syrup production. Remember the hilarious send up on “Carol Burnett”?

Reviewers at Amazon call “Love Story” a cheesy sob story. (“If I ever hear Ali MacGraw say ‘preppie’ again I will probably spontaneously combust,” declares one commenter.)

Sobering Reality of Real Life…

I agree with all of those observations. And, a few years ago, I would also have hooted about a specific plot point—McGraw’s character dies at age 25 after being diagnosed with leukemia. Unfortunately, I have lost many friends to metastatic breast cancer (MBC). I know from painful experience that people do indeed die from breast cancer in their 20s and 30s.

Bridget Spence was 29.

What can you say about a 29-year-old-girl who died? That she was beautiful. And brilliant. And that this just totally sucks.

Bridget was diagnosed with breast cancer at 21. She had no family history. I used to think cases like hers were rare. Now I’m not so sure. As a patient advocate for people with metastatic breast cancer, I know a lot of people with both early and advanced breast cancer and they are young, old,  and all points in between. But I was frankly shocked when I saw the turnout for the “Under 40 & Living With Metastatic Breast Cancer” panel at the 2012 MBCN Conference.

Jen Smith, 36, has been living with Metastatic Breast Cancer since age 31, shortly after her son’s birth.

It seems like I know an awful lot of young mothers like Jen Smith  with metastatic breast cancer. Now, I consider myself fairly well informed on breast cancer risks such as gender, family history, dense breasts and so on. I knew that NOT having children increased a woman’s risk, due to the unopposed flow of estrogen. But until this year, I never knew that recent childbirth can temporarily increase one’s breast cancer risk. As noted on www.cancer.gov: 

Women who have recently given birth have a short-term increase in risk that declines after about 10 years. The reason for this temporary increase is not known, but some researchers believe that it may be due to the effect of high levels of hormones on microscopic cancers or to the rapid growth of breast cells during pregnancy (15). [Source: http://www.cancer.gov/cancertopics/factsheet/Risk/reproductive-history]

I don’t recall ever seeing any article or other information on this issue. I would guess that many obstetricians assume—as seems reasonable—that cancer is a disease of aging. And nursing mothers have a host of potential breast problems: blocked milk ducts, soreness, etc.

But I don’t seem to be the only one who thinks more young women—mothers and non-mothers alike—are getting metastatic breast cancer.

Is MBC Incidence  Rising in Young Women?

Rebecca H. Johnson, MD, of Seattle (Washington) Children’s Hospital and the University of Washington in Seattle, noticed that evidence from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database suggested that  incidence of metastatic breast cancer in young women is on the rise. Johnson and her fellow researchers recently released a study that found “a small but statistically significant increase” in metastatic breast cancer over the last three decades among U.S. women aged 25 to 39 years.

The researchers found that in women aged 25 to 39 years, the incidence of breast cancer with distant involvement at diagnosis increased from 1.53 per 100,000 in 1976 to 2.90 per 100,000 in 2009, representing an average compounded increase of 2.07% per year over the 34-year period. No such increase was seen in any other age group or in any other extent-of-disease subgroup of the same age range.

The rate of increasing incidence of distant disease was inversely proportional to age at diagnosis, with the greatest increase occurring in women aged 25 to 34 years.

Dr. Johnson was diagnosed with breast cancer (presumably early stage) at age age 27. “I’d meet young women patients with breast cancer and it seemed like a lot of friends of friends had breast cancer,” she told @newsJAMA. “And yet the literature kept saying that breast cancer in young women was rare.”

Her  study didn’t  evaluate cause. “The next steps for researchers will be to examine potential causes for this trend and look at etiologies,” she said. “Given there’s such a change over a short amount of time, we may find modifiable risk factors or potentially toxic exposures that are fueling this increase.”

She further explained that the research shouldn’t be taken out of context.  “What the average young woman [under 50] should not do is go get a mammogram, because while on a population level we saw a statistically significant increase, it’s not a large increase of risk for an individual. One thing that has the potential to affect young women’s survival is earlier detection—seeing a physician if you find a lump instead of ignoring it.”

How Can We Manage What We Don’t Measure?

CURE magazine’s Dr. Debu Tripathy noted that the research is based on “cancer registry data, which is very good at capturing data at the time of diagnosis, but not long-term follow-up (other than death). So this is really looking at the less common situation of women who actually present with metastases at the time of their original diagnosis – which only happens about 5 to 10 percent of the time, and perhaps more so in women who do not have access to health care and present with higher stage cancers.”

Dr. Tripathy is correct about that cancer registry data. NCI and SEER database record only incidence, initial treatment and mortality data. And, as Dr.Tripathy further correctly observes, most people do NOT present with metastatic diagnosis. The cancer registry does not track recurrence—which is how the majority of people are thrust into the metastatic breast cancer ranks.

So here’s the good news: Most people don’t start with metastatic breast cancer, which is what the cancer registry tracks.

…And the bad news: We really have no idea what’s going on with, you know, the MAJORITY of people who are diagnosed with metastatic breast cancer after a recurrence. As Dr. Tripathy says, other than death, the cancer registry doesn’t concern itself with long-term data.

So to recap: We know for sure that 40,000 US people die from breast cancer every year. We know that 5 to10 percent of those with metastatic breast cancer were Stage IV from their first diagnosis. So what about the 90 to 95% of those who had a metastatic recurrence? The cancer registry does not track them—until they die.

“While [Dr. Johnson’s] report should not cause alarm or even affect any of our care guidelines, it may be a wake-up call to truly understand what might be driving this,” concludes Dr. Tripathy.

May be a wake up call?

MAY???

Well, gosh, no rush or anything. I mean, if it wouldn’t be a bother, maybe somebody could work on that truly understanding thing.

If I sound angry, it’s because I am. And so are my fellow patient advocates.

If Not Now, When?

“We need focused research to change incurable metastatic breast cancer into a treatable, chronic condition like HIV-AIDS–where patients can now live for 20-30 years with treatment after their diagnosis,” says Shirley Mertz, President of MBCN. “If gay men, who were then scorned by society in the 1980s, could demand and receive focused research and treatments for their disease, why can’t we women–who are wives, mothers, daughters, sisters and grandmothers AND over half of the population–receive similar research that will find strategies to keep us alive for 20-30 years?

“Are we not worthy of this effort?  Are we ignored because we quietly live with our disease?”

So, yes, Dr. Tripathy, you bet your stethoscope this is a wake-up call.

Because as Shirley says, “How many more thousands of us must die before the public and our sisters, who have survived early stage breast cancer, stand with us and for us?”

Cancer at any age and any stage is a terrible thing. But it is especially cruel when it happens to young people–women like Bridget Spence, who at age 29 should have just been getting started in life. There are too many women like Bridget, too many of my friends.

Olga Simkin was 34.

Maria Madden was 37.

Jennifer Lynne Strutzel Berg was 37.

Susan Niebur was 39.

Samantha Pritchett was 40.

Dana Robinson was 41.

Rachel Cheetham Moro was 42.

Zoh Vivian Murphy was 45.

Suzanne Hebert was 47.

Martha Rall was 49.

I have to repeat Shirley’s question. How many thousands more of us must die?

The Long View of Breast Cancer Research

Guest blogger: Laura Nikolaides, MS, Director of Research & Quality Care Programs, National Breast Cancer Coalition (NBCC)

Thank you, Laura for allowing MBCN to reblog your remarks on the breast cancer research landscape and on NBCC projects and priorities, given during the opening plenary of the Collaborative Summit on Breast Cancer Research in Washington D.C., held January 31- February 1. The goal of the Summit was to gather researchers, funders, advocates, and industry representatives together to assess the breast cancer research landscape and to develop collaborative projects for moving forward.

 We have added emphasis and subheadings to some sections. Original blog at: Laura Nikolaides Speaks at Collaborative Summit on Breast Cancer Research in Washington, DC

WHAT ABOUT OUR DAUGHTERS?

I am excited to be here and to have the chance to talk about the bigger picture of breast cancer research, where we have been and where we should be going. So much of the year is spent down in the weeds when it comes to breast cancer research, when we attend the ASCO meeting or SABCS, or when we review grant proposals, so it is gratifying to have this opportunity to for all of us to pull our heads up from the weeds and to discuss the long view.

And for me, the long view, means thinking about my 13-year-old daughter. Where do we need to be by the time she and her friends are adults? Are we on track?

Will things be dramatically different in ten, twenty, thirty years when it comes to breast cancer?

Or will mothers, grandmothers and young women and even men still be dying of breast cancer? Will we know by then why breast cancer cells can lay dormant for 15 years to reemerge and metastasize? Will we know how to eliminate those dormant cells from the beginning? And what about women who have aggressive disease from the get-go. Will we understand why it developed and more importantly know how to stop the progression for the long-term?

TOO MANY QUESTIONS REMAIN UNANSWERED

Unfortunately, I don’t see dramatic change on the horizon with current approaches.

The ACS [American Cancer Society] predicts that over 300,000 women will be diagnosed this year with in situ or invasive breast cancer. Dr. Gil Welch and others predict that between 30 to 50% of those could be considered overdiagnosis. We continue to add more women into the equation, putting them at risk of harm from treatments, and yet, are we seeing a difference in the measures that matter? Yes, we have seen steady, incremental declines in breast cancer mortality since the early 90s, but there has been no acceleration in this decline. And do we know what this really means? What IS working for women and what is not? Do we know how many women have died from the treatments? Do we know if death from breast cancer is being delayed rather than prevented? Are we really any closer to knowing how to prevent breast cancer or a breast cancer death for an individual woman?

NO REAL PROGRESS ON THE METASTATIC FRONT

What we do know is that the rate of diagnoses of Stage IV disease has remained constant for 30 years. What we do know is that 40,000 women and men will die from the disease again this year. What we do know is that the median survival for metastatic breast cancer has remained constant, at about three years.

With billions in resources and decades of effort, we see discovery of new targets, and development of new agents, that extend life by three to four months at a time, if we are lucky. We are learning a lot about the DNA of breast tumors, and the layers of complexity involved, but are we really gaining a better understanding of the why and how of breast cancer? The kind of understanding that will allow for development of gamechangers?

A pharma analysis report prepared a few years ago concluded that with what is currently in the pipeline, and based on historical trends, the median survival for metastatic breast cancer will inch forward from three years, to three years and six months by the year 2021.

Important progress and critical efforts, yes, but is it good enough? No, it is not good enough. We can and must do better. We need new approaches to complement the old ones. We need new ways to look at the disease. We need to find approaches that give us hope of doing better. Targeting of mutations alone, in a disease that constantly grows and mutates, will never be enough.

NBCC’S 2020 DEADLINE TO END BREAST CANCER

In 2010, NBCC set a deadline. By the end of the decade we need to understand much more about metastasis and about development of primary breast cancer, so that we can prevent deaths and end this disease. The deadline is a tool to cause disruptive change.

The purpose is to shift the focus, to look at the disease differently, to consider new approaches that give us hope of doing better.

How do we get there?To achieve success we have to do more than bring everyone together who works in the field, increase funding, and see what happens.

We need to demand more focused research with the end results in mind. We need to bring new perspectives to the table. We need more translational research. And we need to measure what matters. It may just take having specific goals in mind, timelines, and yes, deadlines to get us there.

Many say to us, that’s not how science works. But, I know how science works. I did graduate work in nutritional biochemistry at Cornell University, I carried out a large thesis project involving lactating rats, looking at the impact of malnutrition on milk composition. I know that science works by asking questions, and figuring out how to test theories about the answers to those questions.

SCIENTISTS CAN MEET DEADLINES

So what if we can all agree on what those questions should be? Questions that will help drive us to an understanding of how to prevent deaths from breast cancer? Science can work towards meeting goals and yes – even meeting deadlines. I know I had to answer my research questions in a certain time to finish my thesis and graduate. Scientists meet deadlines all the time.

Right now, in the field of breast cancer research, we have many people asking many questions in an infinite number of directions. We are producing incredible volumes of information. But for all of that effort we are seeing minimal benefit for women. Something has to change.

We need leadership and coordination of efforts, sharing of information, all of us working together on common goals. We need the will to ask the right questions, and the resources to explore those questions. And then we have to measure what matters to judge success.

PATIENT ADVOCATES AND RESEARCHERS COLLABORATIONS

NBCC has spent the last two years exploring how to do this on a small scale with what we call Artemis Projects. These are a series of collaborations among patient advocates and researchers from diverse perspectives. The purpose of the collaborations is to develop strategies, research plans and timelines for answering key breast cancer questions. Patient advocates are there to make sure efforts are always focused on the end result.

The first of our Artemis Projects was launched in 2011, bringing together a group of advocates and scientists to take a strategic, systematic yet broad approach to the development of a breast cancer preventive vaccine within five years. We bring together a group of close to 40 each year to assess progress and to readjust plans. We also hold smaller meetings to bring together experts to bear on particular issues as needed, and have an online community for the project to keep things moving in between meetings.

SEED GRANTS TARGET VACCINATION RESEARCH AND MORE

As most of you know, we don’t typically fund research directly. But through the generous support of National Philanthropic Trust (NPT), NBCC has awarded two seed grants as part of this project, one to Dr. Paul Spellman and Dr. Joe Gray of Oregon Health and Science University to identify possible vaccine targets using existing and developing human genomic data within different breast cancer subtypes.

And a second seed grant was awarded to Dr. Paul Ewald at the University of Louisville, and Dr. Vladimir Belyi of The Cancer Institute of NJ to look at infectious agents and breast cancer. Bioinformatic tools will be used to take a systematic approach to intersect the genomes of known viruses and a broad array of cellular pathogens to identify their presence and prevalence in breast cancer genomes relative to normal breast tissue. Initial data from both of these seed grants will be presented at the next annual meeting in March.

MORE METASTATIC RESEARCH

We will also be kicking off a second Artemis Project on Metastasis in June to focus on tumor dormancy.

As with the Artemis Project on the Preventive Vaccine, our goal is to bring together investigators with diverse perspectives to brainstorm and develop innovative strategies for accelerating progress.

EYES ON THE PRIZE

In summary, I think we do have the will and the resources to come together on asking the right questions. We have heard from others this morning about new initiatives focused on prevention and metastasis. I see positive steps being taken to prove that pharma analysis wrong. If we can keep the end result in mind, where we want to be when all of those 13 year olds are 21 year old adults and beyond, I feel hopeful we can change the course. I look forward to the rest of the meeting for further discussion on how we are going to get there. Thank you.

Editor’s note: Shirley Mertz will represent the Metastatic Breast Cancer Network at the Tumor Dormancy Summit in June.

Why I Volunteer (I’m not metastatic)

I do not have metastatic breast cancer (MBC).  In March 2010 at age 62 I was diagnosed with early stage breast cancer.  A routine mammogram showed what appeared to be DCIS in my right breast.  After further diagnostic tests and consultations with three different surgeons, I had a right mastectomy and opted for a prophylactic left mastectomy. Upon tissue analysis of my cancerous right breast, my diagnosis was revised to invasive breast cancer, Stage 1. My oncologist tells me that based on my diagnostic tests, tissue analysis and treatment choice, I have less than a 2% risk of recurrence.  I currently take no medication and have oncology visits every 6 months.

So, in the absence of having metastases, why would I have an interest in volunteering with MBCN?  That was Joani’s question to me after mentioning that I was the first volunteer with whom she spoke who did not have metastases and who wanted to volunteer with MBCN.  I must admit that I was rather surprised to hear that because I learned, through the links of MBCN, that as many as 30% of all women diagnosed with early breast cancer will develop metastatic cancer.  One needs only to read the biographies of two MBCN Board Members, Ginny Knackmuhs and Shirley Mertz, to see that DCIS, Stage 0, reported by some in the medical community as 100% curable, is not excluded.  No one diagnosed with early stage breast cancer is safe from MBC.  So, it is for very personal reasons that I would like to contribute my time to this organization to help create a greater awareness of MBC and hopefully generate an interest for more funding to study the complexities of metastatic cancer.

Most importantly, I want to offer my support to the amazing women whose stories I have read on the MBCN website in both the ‘Your Stories’ section and the ‘Board of Directors’ section. The courage and strength of these women and all women and men living with MBC is truly inspirational to me. For those  having metastases, every day is filled with the worries of diagnostic procedures and outcomes, treatment choices, the effects of the emotional rollercoaster, and the successful management  of everyday family life. These are difficult challenges faced by individuals every minute of every day.

Although I don’t have MBC, I still feel a kinship with the women and men of MBCN as I feel a kinship with all individuals having breast cancer. I have often said that those of us who have breast cancer are lifetime members of a very special, unique ‘club’ where the camaraderie is unparalleled, yet no one wants to join. The strength of this bond is very visible throughout the history of MBCN and it is my honor to volunteer my time for this organization.

Elaine Botsford

I don’t like the word SURVIVOR

I don’t like the word SURVIVOR; matter of fact, I have a deep aversion to it.

Why is this word used to define those of us with stage IV breast cancer? Why is it even used to describe people who have been treated for earlier stage bc?

When I think of the word, I think of concentration camp survivors or survivors of other persecutions.  These people lived through unspeakable horrors, escaped death and continued to move forward. I haven’t earned this word and, frankly, it just doesn’t fit.

I am not a survivor of bc.  To put it bluntly, unless the proverbial bus hits me, I will die of bc.  Yeah, yeah, yeah, cancer is an internal masochist and like you all, I need to treat it as the enemy in order to live but I am still LIVING.  Survivor implies completion and finality.

I also wonder if the rampant use of the word survivor has lulled all involved in bc – patients, researchers, doctors, pharma companies and bc organizations into a false sense of complacency.  If we are all survivors then why do we need to do more?  What justification is there to fund more research and to push for more treatments?  I want the public at large, to see me as I am – a woman trying to control a deadly disease as long as possible.  I am living until I am dying.

What do you think?

Joani