You have many options to consider for clinical trials
Tips: Make your search broad first by entering in the first search box advanced breast cancer, breast cancer metastasis, metastatic breast cancer, stage IV breast cancer. If you want a more specific search return, you can add types of MBC such as TNBC, Her2+ or positive, Her2- or negative, ER PR + …etc.)
You may want to consider traveling to a clinical trial site. Sometimes the clinical trial can provide a stipend for travel or resources for lodging during your treatment.
Two programs are available for you to explore if you are out of treatment options: Right to Try and Compassionate Use. Metavivor patient advocates worked very hard to pass the Federal Right To Try act in 2017 and 2018. In 2018, the Federal Right To Try Act was signed into law. It isn’t widely used because most patients are not aware of it.
Right-to-try laws are U.S. state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA).
This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments.
Patients should first consult with their physician and that their physicians consult with the sponsor of the investigational drug or biological product. The sponsor is in the best position to provide information about whether the drug or biological product meets the criteria to be considered an eligible investigational drug for use under the Right to Try Act.
Sometimes clinical trial enrollment is not possible for those living with metastatic breast cancer. Patients may therefore seek access to investigational medicines outside of a clinical trial.
Sometimes called “expanded access”, compassionate use is a potential way for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. This is a potential solution when patients run out of treatment options but do not have access to a clinical trial.
Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem.
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
There are four phases of clinical trials:
Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.
Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
Discuss the possibility of a clinical trial with your doctor. ClinicalTrials.gov has information on clinical trials from 50 states and 209 countries. You can search on Metastatic or Advanced Breast Cancer and see all trials or you can be more specific about your subtype or the organs where your breast cancer has metastasized. We feel this search tool is the best because it gives you options for current trials and also allows you to review results of trials that are complete.
