Metastatic breast cancer (mBC), or stage IV breast cancer, occurs when cancerous cells have spread beyond the breast and nearby lymph to other body parts. Once the cancer has spread to other organs, treatment can become very challenging.
Because mBC quickly spreads to other areas of the body, it can be considered an aggressive type of breast cancer. “Patients with metastatic breast cancer will need to receive personalized treatment for the rest of their lives,” says Tingting Tan, MD, PhD, a medical oncologist and hematologist specializing in breast cancer at City of Hope.
Because there’s no cure for metastatic breast cancer, ongoing clinical trials are crucial for creating more effective treatment options. Dr. Tan says that people with mBC may need to switch treatments when drug resistance occurs or when the cancer progresses.
Clinical trials for metastatic breast cancer aid researchers and medical teams in improving outcomes, managing symptoms, and increasing life expectancy.
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What are Clinical Trials?
Clinical trials are research studies that test new medical interventions on people with various medical conditions, such as metastatic breast cancer.
Here are the four phases of a clinical trial, which include:
- Phase I: Researchers assess the safety and optimal dosage of a treatment. This phase is typically conducted with a small group of patients (20 to 80), most of whom have metastatic breast cancer.
- Phase II: During this phase, researchers consider the treatment’s effectiveness and continue assessing safety. This phase can include 100 to 300 research participants.
- Phase III: Researchers seek to yield significant conclusions backed by data that address side effects, confirm efficacy, and compare to existing mBC treatments. At this point in the trials, there are 1,000 to 3,000 participants.
- Phase IV: By this stage, the U.S. Food and Drug Administration (FDA) has approved the drug for public use. Researchers are now gathering additional data about a treatment’s risks, benefits, and optimal use for the general population.
“Clinical trials are key to the development of innovative therapies, such as targeted drugs, to fight a wide range of cancers and other diseases and moving them toward FDA approval,” Dr. Tan says.
Benefits of Participating in a Clinical Trial
Participating in a clinical trial for metastatic breast cancer can have many benefits, including access to new treatment options, contribution to scientific research, and comprehensive and attentive medical care.
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“For patients with metastatic breast cancer, clinical trials can bring life-changing and potentially even life-saving benefits, particularly for patients whose current treatment has stopped working and need new options,” Dr. Tan says.
Here are the benefits of joining clinical trials for metastatic breast cancer:
- Access to new treatment options: By participating in new immunotherapy, chemotherapy, and other target therapies still in clinical trials, you may find renewed hope in your fight and a treatment that best suits your health needs.
- Contributing to cancer research: Your participation can help advance medical knowledge and cancer research. Contributions from clinical trials can lead to significant breakthroughs that help patients and improve survival rates.
- Quality health care: By enrolling in a clinical trial, you’ll have a dedicated health care team that closely supervises you. As the medical and research continue their cancer research, they will continuously monitor your health and provide more medical attention than you would otherwise receive.
Types of Clinical Trials for Metastatic Breast Cancer
Two treatments involved in clinical trials for metastatic breast cancer are targeted therapy and immunotherapy.
Targeted therapies involve drugs targeting specific proteins in cancer growth and progression. Clinical trials involving targeted therapies typically test drugs that can intercept these proteins to stop the spread of cancer. Immunotherapy uses the body’s immune system to attack cancer cells. Immunotherapy trials for metastatic breast cancer may test drugs like checkpoint inhibitors (pembrolizumab).
Trials are also being conducted to test chemotherapy combinations with newer targeted therapies to assess their effects on tumor reduction and patient survival rates.
Numerous institutes, including Memorial Sloan Kettering Cancer Center and the National Institutes of Health, are currently conducting trials for immunotherapies and targeted therapies.
Finding a Clinical Trial
If you want to participate in a clinical trial, Dr. Tan recommends speaking with your oncologist first.
You can also go online to find clinical trials near you. Resources for metastatic breast cancer trials include the following:
- ClinicalTrials.gov
- BreastCancerTrials.org’s Metastatic Breast Cancer Trial Search
- National Cancer Institute (NCI)
- Karmanos Cancer Institute
- BlackDoctor.org’s Clinical Trial Resource Center for Black Americans
Be sure to discuss your options with your healthcare provider to determine if participating in a clinical trial for metastatic breast cancer is the right treatment option for you.
Considerations for Participation
Every clinical trial is governed by various guidelines. “Guidelines cover the type of disease, age, medical history, current medical condition, and other factors of potential participants,” Dr. Tan explains. “You have to meet the criteria of a clinical trial before you can enroll in it.”
Please be aware that joining a clinical trial can involve risks and a significant time commitment. Speak with your healthcare provider about any potential risks and concerns you may have about participating in cancer research.
Final Thoughts
Clinical trials remain vital to treating metastatic breast cancer and all cancers. These trials facilitate medical breakthroughs that help manage symptoms and increase disease survival rates. Cancer research continues to rely on participants’ willingness to be at the forefront of testing new therapies.
Your decision to participate in a clinical trial is not just a courageous step in your fight—it is a selfless decision that can contribute to the fight against metastatic breast cancer.
