What happens when you join a breast cancer clinical trial?

Breast cancer clinical trials often test new ways to prevent, diagnose, and treat the disease. Medical experts in the field say clinical trials are one of the main reasons breast cancer has improved over the past 30 years.

During breast cancer treatment, you may be offered a clinical trial. So, if you’re thinking about doing a breast cancer clinical trial, how would you feel?

First, do your research. The results of clinical trials determine whether or not potential new treatments will become standard care for breast cancer. Some treatments originally used for metastatic breast cancer may even cross over to be tested and used to treat early-stage breast cancer or other types of cancer. It is also possible that drugs previously approved for other types of cancer may be tested in the future for the treatment of metastatic breast cancer.

A few considerations.

  • Side effect: The risks of a potential new treatment may not be fully understood, so there may be unexpected side effects. Although testing minimizes risks, side effects of new treatments are often not fully revealed until long-term testing and follow-up. However, when additional side effects or safety information becomes known, that information is provided to physicians and is regularly updated as new information becomes available.
  • Travel time and costAlthough trials are available nationwide, there is no guarantee that appropriate trials will be available in your area or at your original oncologist. However, trial participants typically receive their care in the same places where standard treatments are administered: clinics or doctors’ offices. If travel to a separate site is required, some trial organizers may provide transportation or reimburse participants for the cost of travel.
  • Healthcare costs. The cost of the potential new treatment will usually be covered by the study itself, and many health insurers will cover the standard of care given in the study, just as they will for current breast cancer treatments. However, it’s important to check with the study team and your insurer to make sure there won’t be any unexpected costs for joining the study (such as out-of-network fees).

Each clinical trial is led by a principal investigator (called the principal investigator or PI), who works with a team of other scientists and health professionals. The way a research team designs and conducts a clinical trial can vary based on the goals of the study and other factors.

If you have been asked to take part in a trial, your doctor or research nurse will discuss what exactly is involved with you. You will be given written information with all the details of the proceedings. This should include information about the type of test, potential benefits and risks, and the need for additional tests or hospital appointments. All participant information is kept confidential.

Participants will be observed regularly and their case data will be carefully recorded and reviewed and compared with other trial participants. You may have additional visits between treatments to make sure there are no unexpected side effects.

There are many safeguards in place to ensure the well-being of clinical trial participants. These guarantees cannot guarantee that you will not have complications, but they are meant to reduce the risk as much as possible. Clinical trials are overseen by an investigative review board (IRB) to protect the rights and well-being of trial participants.

If at any time during the study you or your doctor feel that it is in your best interest to stop participating in the trial, you will be free to do so. And it will in no way affect your ability to heal in the future.

Remember, like all aspects of cancer treatment, the decision to join a clinical trial is a personal one. Even if you decide not to join a clinical trial now, that doesn’t mean you can’t join later if you’re eligible. For information on specific breast cancer studies, visit Gilead’s clinical trials website.

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