Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer that tests negative for the three molecular components of breast cancer cells: estrogen receptors, progesterone receptors, and human epidermal growth factor protein (HER2). TNBC is more common in women under 40, Black women, or women with a BCRA1 gene mutation.
According to Michael S. Simon, M.D., MPH, medical director of the Cancer Genetic Counseling Program at the Barbara Ann Karmanos Cancer Institute and clinical professor of Hematology and Oncology at Wayne State University School of Medicine, “Patients who have TNBC have more aggressive disease and are more likely to relapse if diagnosed at an early stage. There is also a worse prognosis if the patient is diagnosed at the advanced (stage 4) stage.” However, he says TNBC patients are more likely to respond to chemotherapy and combination chemotherapy and immunotherapy.
Here’s why clinical trials might be a beneficial option for those undergoing or seeking TNBC treatment.
According to the National Cancer Institute, clinical trials are medical studies that test how medical screening, treatment, and prevention methods work in people. Different cancer clinical trials may test drugs, vaccines, radiation, chemotherapy, and treatment combinations.
There are four phases of clinical trials. Phase I tests both the dosage and whether a treatment is actually safe to administer. Phase II tests how the cancer responds to the treatment. Phase III examines how the treatment is doing compared to other existing treatments. Phase IV is a wider distribution and approval of the treatment, along with analysis of the long and short-term side effects.
Clinical trials play a significant role in developing new treatments. Although they come with some risk, trials are highly sought after by people seeking relief from illnesses that don’t yet have a cure or aren’t responding to existing treatment offerings.
“Given that TNBC is especially aggressive and has a higher likelihood of relapse than other breast cancer subtypes, it is especially important to explore new avenues of treatment that would result in better outcomes, including better survival for patients with this type of breast cancer. Clinical trials have been important in advancing more effective combinations of chemotherapy and have shown the efficacy of newer classes of treatment for patients with TNBC, including immunotherapy and antibody drug conjugates,” Dr. Simon offers.
Eligible patients can access new and potentially life-saving treatments that are not yet widely available to the public. According to Memorial Sloan Kettering Cancer Center, clinical trial participants are usually not expected to pay anything more than their insurance already provides. Typically, the research institution pays for research-related costs. Details are shared in an informed consent form required from clinic trial patients.
Despite the obvious risks, clinical trials can prove mutually beneficial. Participants may get life-changing support and medical treatment. In turn, the data gathered from lengthy clinical trials contributes to scientific advancements that help doctors like Simon understand complex and often rare diseases. It can also uncover ethnic and racial differences that can end disparities in care and treatment.
New developments for triple-negative breast cancer research and treatments are happening in medical centers and universities around the world. Some institutions with ongoing clinical trials for TNBC treatments include the Mayo Clinic, the Moffit Cancer Centre, the University of California San Francisco, the University of California San Diego, and the MD Anderson Cancer Center at the University of Texas. The types of trials vary greatly from de-escalating therapy for early-stage patients to molecular disease detection to tumor indications. Each trial outlines its timeframe, unique research premise, and target breast cancer stage.
Clinical trials for different diseases, including TNBC, are ongoing across the country. To find a suitable one, Dr. Simon says to consult with a medical oncologist who is aware of the trials available at their institution and at other local or national institutions. Various national cancer websites, including the American Cancer Society, are also sources of information about clinical trials.
Also, search BlackDoctor.org’s vetted list of clinical trials aimed at Black Americans, including those for triple-negative breast cancer. Clinicaltrials.gov a National Institutes of Health registry, also lists federally- and privately-funded global clinical trials.
The Triple Negative Breast Cancer Foundation also has a clinical trial matching service to narrow down search results, seek targeted support, and connect with study teams. Always consult with a doctor before making any final decisions about volunteering for a clinical trial.
Before volunteering to participate in a clinical trial, there are eligibility criteria and potential risks to consider. Eligibility criteria for clinical trials commonly consider factors like age, sex, and medical condition. It may be cumbersome to navigate the multiple layers of eligibility requirements and any pre-trial food, diet, and lifestyle changes the research may require.
It’s also important to remember that because treatments are still in the trial and testing period, there is no guarantee they are effective. It’s also possible volunteers could experience unexpected and severe side effects.
Discuss the possibilities with your current doctor and weigh the risks versus the rewards.
Clinical trials can offer new hope and treatment options for patients suffering from TNBC. Research findings today can improve treatment outcomes for generations to come. For those considering clinical trials, talk to your doctor first and decide together how a clinical trial could help you treat TNBC.
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