Angels Paying Forward: Clinical Trials And Breast Cancer

Clinical trials are frequently taken for granted by the cancer community–by patients, caregivers, and clinicians alike. Those trials are the backbone of the recommendations we make for cancer treatment. How often do we take a moment to think about the incredible patients and families who participated in those trials, trials which make such a difference in the lives of so many every day?

Those people, my friends, are angels who made so much of our progress possible. We owe them an incredible debt of gratitude for what they did when they “paid forward” with their commitments to advance our knowledge of cancer care by participating in thousands of trials over decades. Without them, we would never have made so many advances in cancer treatment and achieved what success we have had in reducing the burden and suffering from cancer.

Trialjectory is a company focused on engaging cancer patients with clinical trials and helping them through the process of finding trials that have relevance for their care. I am an advisor for Trialjectory and recently participated in a webinar they sponsored on the topic of the empowered patient.  My co-panelist was a young woman, a breast cancer survivor, a nurse, and perhaps one of the most articulate and effective patient voices I have had the opportunity to hear on the topic of cancer care. Her name is Seona Furlong.

My “moment” occurred while Seona was describing her cancer journey, from first finding a mass in her breast to the initial evaluation to treatment and its consequences and to her current condition, which is excellent. She emphasized to the audience that her engagement in her care and with her care team along that path gave her a sense of participation and control over her treatment and her disease, with a message for the online community watching the webinar that they should not be afraid become more active in their care.

Then it struck me: here was this young woman who had come so far in her illness, and I realized that every step of her journey represented years of work through research and clinical trials to get her to this day.

That may not sound like much to you however I lived through much of that effort over the course of my career, which has spanned decades. So I shared with the audience some of the significant advances made possible by clinical trials that now have such a major influence on our care and outcomes for breast cancer.

Let me take a moment to share some of those advances, in no particular order of time or importance:

When I started my oncology practice in 1977, mammography was just coming into its own as a means for the early detection of cancer. Backed by research started in the 1960s, we had gotten to the point where mammograms were generally available, and instead of finding advanced breast cancer at diagnosis through palpating a lump in the breast we were now beginning to find cancers before they were detectable by routine examination when treatment could be more effective.

Then there were the changes in surgery to consider: When I started practice the standard surgical approach to breast cancer was an operation called a modified radical mastectomy with lymph node dissection: a grossly disfiguring operation that required removal of the breast, some chest wall muscles and deep dissection of the lymph nodes. We did not have pre-surgical biopsies, so a woman would be put to sleep and wake up to find out whether she had cancer, and whether or not her breast was still intact. Frankly, it was emotionally draining and barbaric.

Over time, through serial clinical trials, we learned that such surgery wasn’t necessary and that for smaller tumors simply removing the cancer and not the entire breast was sufficient for surgical treatment. Later, we learned about sentinel lymph nodes, reducing the need for lymph node removal for some women. And now we realize that for more women removing the lymph nodes is not helpful in treating breast cancer.

We then learned that we could reduce the chances of breast cancer recurrence using adjuvant, or preventive, therapy after lumpectomy. A number of clinical trials have brought us to the point that we know in some circumstances giving treatment before surgery can in fact destroy all evidence of the tumor for some women, offering them an even better prognosis.

Also beginning in the 1970s we discovered that some tumors had receptors on their cell surface that signaled the cancer cells were more susceptible to hormonal manipulations. Prior to that time, sometimes pre-menopausal women with breast cancer would automatically have their ovaries removed, and post-menopausal women would get high doses of hormones (estrogen, progesterone) if their cancer recurred without any sense whether their tumor was hormone sensitive.

Alternative hormone-related treatments became available starting in the 1970s. Tamoxifen became a standard drug for the treatment of advanced breast cancer in post-menopausal women, followed by aromatase inhibitors and now newer drugs which enhance the hormonal response. We have learned which women need chemotherapy as a preventive treatment after surgery and radiation, and how long they need to receive chemotherapy and hormonal treatments to get the best outcomes and prevent the breast cancer from returning.

We learned that other receptors on the surface of breast cancer cells would respond to then newer drugs focused on those receptor targets. Enter HER2 drugs in the 1990s and early 2000s, with clinical trials showing how very effective those drugs were in reducing recurrence and death for many younger women with more aggressive breast cancer.

Over the years, through research and clinical trials, we have learned which drugs work best for which type of breast cancer. We have learned the best schedule to give those drugs, whether before surgery or after, for how long in what combinations. We have learned how to best use which radiation treatments under which circumstances, and how to tailor the entire treatment “package” for each woman so that she has the best outcome with the least amount of treatment and the most tolerable side effects.

All of this has happened because of clinical trials, and the willingness of patients and their families to participate in those trials over literally decades of clinical research.

The result is that countless lives have been impacted along the way. The rate of deaths from breast cancer has dropped significantly from the early 1990s to the present (although experts are concerned that we may be losing some opportunities for improvement given the problems with access to health care that exist in our nation).

Listening to Seona’s story on that webinar brought home in one moment how all that effort over all those years really has made a difference in the lives of those with cancer. Knowing what to do for someone in their time of need, offering them a path forward based on knowledge and evidence, giving them information they need to understand the choices that must be made—all of that together is a result of many factors, not the least of which is the power of clinical trials. Clinical trials and the people who participate in those trials, thousands of people, many years of research, sometimes successful, sometimes not, always focused on helping to take another step forward to bring us where we are today and hopefully take us to a better place we want to be tomorrow.

The American Cancer Society estimates that in 2022 there will be about 1.9 million people diagnosed with invasive cancers. Best estimates are that about 5% will participate in clinical trials. I suspect that 100% will benefit from some element of knowledge gleaned from a prior clinical trial during their cancer journey.

As clinicians, we learn from every patient we treat. Through clinical trials we can pay back and pay forward those who in the past made their personal contribution to improving our individual care today and pave the way for better understanding of cancer and better treatments for cancer in the future.

I still remember talking with patients and families about participation in clinical trials focused on breast cancer when I started my practice in the latter 1970s. I remember placing patients on trials with new treatments designed to reduce the chances of cancer recurrence. I remember how little we knew then compared to what we know today.

Many if not all those women are no longer with us. They represent but a very, very tiny fraction of those who have participated in breast cancer trials over the following decades. However, I suspect that each one would be grateful knowing that they made a genuine difference in helping women today look forward with more hope and more optimism than would have been the situation otherwise.

May God bless their memories, for they were angels and they were pioneers moving along an uncharted path. They truly made a difference, and in their light we see light for so many every day.