It’s good to participate in breast cancer clinical trials if patients can locate an appropriate trial for their specific breast cancer (BC) subtype and/or molecular make-up. However, let’s first discuss how to find clinical trials most effectively.
Enhancing Recruitment for Breast Cancer Clinical Trials
One of the biggest challenges in successfully completing clinical trials is recruiting a sufficient number of participants. A robust clinical trial design must estimate the number (i.e., sample size) of patients necessary to detect treatment differences among the trial arms. Otherwise, the sample size is “underpowered”—i.e., it’s not sufficient to answer the study’s research question.
Unfortunately, having certain health conditions and being a clinical trial participant may be stigmatized due to certain cultural or generational beliefs or false assumptions. Such a sense of stigma, including among some with BC, may cause certain patients to be hesitant about joining a study. In some cases, it may even keep them from seeking medical attention, causing serious, potentially life-threatening delays in diagnosis and treatment.
So, why is it good to participate in breast cancer clinical trials? Because cures begin with clinical trials. All treatments available today that treat cancer or lead to remission were approved by the Food and Drug Administration based on clinical trial results. Who do we have to thank for these life-saving treatments? The cancer patients who wanted to play a role in finding tomorrow’s cures. They have given us all a remarkable gift by choosing to join clinical trials.
Decreasing Perceived Health-Related Stigma
Perceived health-related Stigma (PHS), or negative connotations associated with certain diagnoses, is common with many diseases, including BC. Many patients face changes in body image and may develop anxiety, depression, poor sleep quality, decreased quality of life (QoL), and/or a tendency to avoid seeking medical care.
All members of a BC patient’s healthcare team should be aware of PHS and its potential impact on patient interactions with medical care. They should:
- Proactively discuss the specific BC subtype diagnosed, recommended treatment regimen(s) and potential side effects, and the normal range of emotions that patients may feel due to their diagnosis and its treatments
- Discuss the availability of peer mentor programs, where newly diagnosed patients may speak with BC survivors online or face-to-face support groups or with other supportive opportunities
- Encourage patients to participate in clinical trials to accelerate potentially life-saving or QoL-enhancing treatments
Cures Start with Clinical Trials: Hope and Success
“‘Hope’ is the thing with feathers that perches in the soul—and sings the tunes without the words—and never stops at all.” —Emily Dickinson
Patients and their healthcare teams can work together to replace stigma with hope and recognize that clinical trials continually result in approved treatments, leading to the remission of many BCs. Due to early diagnosis and treatment, studies have shown that the mortality rate in women with BC continues to decline. Although there is not yet a cure for metastatic BC (MBC), research shows that an increasing number of MBC patients are living many years after their initial diagnosis. It’s crucial to highlight stories of hope, where participating in practice-changing clinical trials has accelerated treatments and dramatically lowered mortality rates. Here is one of the most important success stories.
Trastuzumab and HER2+ Breast Cancer
The HER2 gene normally instructs cells to form receptors on their surfaces that send signals regulating the division and growth of healthy cells. However, rather than the average 20,000 HER2 receptors on normal cells, about 15% to 20% of BCs may have up to 2 million HER2 receptors, causing cancerous cells to grow dangerously out of control. The result is HER2+ BC, an extremely aggressive cancer associated with poorer outcomes and higher mortality than other BC subtypes. Yet the introduction of the targeted therapy trastuzumab (Herceptin®) was truly paradigm changing, resulting in a new standard of care for both late-stage and early-stage HER2+ BC.
In 2005, Dr. Edith Perez of the Mayo Clinic College of Medicine attended the American Society of Clinical Oncology (ASCO) Annual Meeting with tens of thousands of fellow cancer specialists. Dr. Perez presented data on trastuzumab, which had already been approved to treat metastatic HER2+ BC in combination with paclitaxel chemotherapy to extend the lives of patients. The next crucial step was determining whether such treatment could delay the spread of HER2+ BC or prevent it from recurring.
As she walked into the conference hall, Dr. Perez described seeing fellow investigators, collaborators, and patients who participated in the trial. There was an electric sense of anticipation as she announced the results, stating, “Adding Herceptin to the chemotherapy regiment reduced the risk of breast cancer coming back by half compared with women who received chemotherapy alone.” She also described potentially serious risks, including heart failure, while emphasizing that the safety profile was consistent with those seen in earlier Herceptin MBC clinical trials.
The large audience was silent at first, as they realized that they hadn’t seen such an advance in BC treatment in nearly thirty years. In the next moment, everyone leaped to their feet and burst into spontaneous applause, with everyone hugging and showing strong emotions. Dr. George Sledge, Jr., a future ASCO President, emphasized that they’d just witnessed the beginning of a new era for BC care, concluding, “Biology has spoken, and we should listen.”
Dr. Dennis Slamon and colleagues championed the development of trastuzumab for more than ten years, conducting the laboratory and clinical research ultimately leading to this first anti-HER2 targeted therapy. In speaking about the group of fifteen women who participated in the first trial, Dr. Slamon referred to them as colleagues, noting, “That whole group left an amazing impression on me. They’d played a critical role in this major part of history, this grand experiment about whether this targeted therapy would work. Everybody talks about targeted therapy today. But back then, there was no such thing.”
That’s just one powerful example of why our motto is, “Cures start with clinical trials.”
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