Clinical trials are an essential part of advancing breast cancer care, offering patients access to potentially innovative therapies and expanded options for treatment. However, navigating pathways to clinical trial participation is often complex, with challenges ranging from eligibility criteria and diagnostic information to financial and logistical barriers.
For many who are living with breast cancer, clinical trials are often thought of as intimidating or inaccessible. With decisions that are based more on fear than hope, many patients close the door to the option of treatment through clinical trials.1 This is why patient navigators are an essential resource in the breast cancer community, as they offer sound, structural solutions and guidance to many of the unknown challenges of clinical trials.
In this piece, we speak with Marcela Orozco, patient navigator with Susan G. Komen’s Patient Care Center (PCC), about some of the ways patient navigators can take some of the guesswork out of clinical trials, making sure the doors to potentially lifesaving opportunities stay open to those who need them most.
One of the first barriers patients encounter when looking for a clinical trial is understanding the complex but needed eligibility criteria. These criteria vary from study to study and may be based on factors such as type and stage of breast cancer, past treatments for breast cancer, or other medical conditions. “Many patients are newly diagnosed and already overwhelmed by medical terminology, treatment decisions, and emotional stress,” Orozco says. “When clinical trials introduce additional concepts like tumor biomarkers, staging, and prior treatment history, things can quickly become confusing.”
This medical information also can serve as a barrier for those trying to learn more about clinical trials. Patients often don’t know how to sift through these data to determine whether their diagnosis fits a particular trial.
“Clinical trial listings can be highly technical, and patients may struggle to understand which factors—such as hormone receptor status, HER2 status, or previous treatments—determine their eligibility,” Orozco says. “As patient navigators, our role is to translate this complex information into language patients can easily understand.”
Once equipped with the right information, patients can feel more empowered to discuss their eligibility for clinical trials with their care team.
Genetic testing may also play a role in determining whether a person can participate in a clinical trial. And while most people initially associate genetic testing with inherited breast cancer risk, it is also a useful tool for patient navigators to help determine clinical trial eligibility.
“Genetic testing often comes up when reviewing diagnosis and pathology results with patients,” Orozco says. “During these discussions, we explore how testing for inherited mutations could potentially influence treatment options, including clinical trials.”
Clinical trials can also help people who are not diagnosed with breast cancer but carry a hereditary mutation that could put them at higher risk. Many clinical trials focus on lowering breast cancer risk, improving screening, or preventing the disease altogether.
“As patient navigators, our role is to help patients understand the significance of genetic testing and encourage them to discuss outcomes with their care team, when appropriate,” Orozco explains. “Understanding these test results can open doors to trials specifically designed for patients with certain genetic profiles.”
Pathology reports are a fundamental part of a patient’s cancer journey, but they can be difficult to understand. These reports contain detailed information about the tumor type, receptor status, grade, margins, and other diagnostic factors.
Patient navigators help walk patients through these reports in plain language. “We explain key terms, highlight the information most relevant to treatment planning, and help patients understand which elements may affect their eligibility for clinical trials,” Orozco says.
Patient navigators can also help translate the clinical data found in pathology and diagnostic reports. “Many patients are encountering complex medical information for the first time,” Orozco says. “I help them break down this information step by step, so they can understand how it could impact their treatment options.”
Orozco says she and her team often review key elements of an individual’s diagnosis that influence trial eligibility, such as tumor biomarkers, stage, and prior treatments.
“When genetic or biomarker testing results are available, we discuss how those findings might relate to specific clinical trials,” Orozco says. “My goal isn’t to recommend a particular trial—that decision is made by the patient and their medical team—but rather, to ensure patients have the knowledge and confidence to explore their options.”
Educational resources are powerful tools that contain information to help guide treatment options, including clinical trials. “Here at Komen, our patient navigation team provides educational resources that explain what clinical trials are, how they work, and address common myths and facts to help alleviate fears,” Orozco explains. The PCC navigation team also provides guidance on what questions patients should ask when considering participation in a study.
“I often recommend resources like BreastCancerTrials.org, which offers a patient-friendly clinical trial matching service specifically for breast cancer,” Orozco says. “Patients can enter information about their diagnosis, treatment history, and other clinical details to receive personalized trial matches.”
BreastCancerTrials.org also provides clear, easy-to-understand summaries of clinical trials, along with access to clinical trial navigators who can help people explore their options and advise them on how to bring those opportunities to their healthcare team. Komen’s “Clinical Trials” webpage on komen.org also provides additional resources and educational information about clinical trials.
By using trusted educational resources and tools, people can feel more informed and less intimidated by the clinical trial process. Moreover, they are better prepared to discuss clinical trials with their doctors and decide if participation is right for them.
Financial concerns are one of the biggest barriers patients face when considering clinical trials. Many worry about costs related to travel, time off work, lodging far from home, or additional medical expenses associated with participation in a study.
Orozco and her team work closely with patients to identify resources that can help alleviate these burdens. This may include connecting them with financial assistance programs, transportation support, lodging resources, or grants that cover nonmedical costs associated with trial participation.
“Recently, I worked with a patient with metastatic breast cancer who was interested in exploring clinical trial options but was concerned about the financial and travel requirements,” Orozco says. “I provided her with information and resources, and her oncology social worker was able to connect her with a clinical trial opportunity in Texas. The trial program would cover her flight, lodging, and meals during her participation. When she shared the news with me, she said it made her feel like she was ‘going on vacation.’”
Stories like this highlight how crucial it is to connect patients with the right financial resources. When financial and logistical barriers are addressed, patients are free to focus completely on their treatment and empowered to go after opportunities that once felt out of reach.
One of the most important ways patient navigators support patients is by helping them prepare for conversations with their healthcare team. When it comes to clinical trials, many patients feel unsure of what to say or worried about saying the wrong thing. To address these challenges, Orozco says she equips patients with the guidance and confidence they need to have meaningful conversations.
“I encourage patients to come to appointments with questions and provide examples of what they might ask, such as whether clinical trials are available for their diagnosis, what the potential benefits or risks might be, and how participation could impact their treatment plan,” she says.
When patients have the right knowledge and know what questions to ask, everything changes. They’re able to take a more active role in their care and have meaningful conversations with their doctor about whether a clinical trial could be a good fit.
Patient navigators can open new doors to care and empower patients to explore the uncharted and exciting landscape of clinical trials. In the end, it’s about helping patients feel confident in their decisions and in control of their care, every step of the way.
Click here to learn more about our Patient Care Center, or call 1-877 GO KOMEN (1-877-465-6636) or email This email address is being protected from spambots. You need JavaScript enabled to view it. to connect with a trained navigator.
Check out Komen’s Navigation Nation Training Program, which features a clinical trial navigation course designed to equip patient navigators with the skills to guide patients toward clinical trial opportunities.
Komen’s Clinical Trials page features our clinical trial education programs, which include helpful resources and educational information on clinical trials.
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