Breast cancer trials tend to be a difficult topic to understand and talk about. Some people still believe that breast cancer trials are a last resort for treatment, which actually isn’t true (more on that later). Here’s everything you need to know about these trials, and how to participate in one if you feel it is right for you.
What are clinical breast cancer trials?
Doctors and scientists are constantly exploring innovative ways to treat breast cancer patients. This includes the use of clinical trials. These involve volunteers to make scientific discoveries. Clinical trials are used to treat breast cancer of all forms and stages. These studies look at new medications, different treatment combinations, new approaches to radiation therapy or surgery, and new treatment strategies. The volunteers who participate in clinical trials can be some of the first to get a treatment before it is available to the public.
However, there are some risks with a clinical trial. This includes possible side effects and the chance that the new treatment may not work. As with all things, there are pros and cons to trials. So patients are encouraged to talk with their healthcare team about any study they may be a part of.
Joining a Clinical Trial
If you are on board with joining a clinical trial, there are a few steps that you’ll have to take before you can officially be a part of one. If you’re eligible, your doctor or specialist may offer you the opportunity to participate in a clinical trial. You can also ask about a trial you’d want to participate in or if there are any others that would be acceptable for you.
Every clinical trial has specific rules about who can participate. For example, the clinical trial may request information on:
- Your specific age or gender
- Your medical tests and medicines you’re currently taking
- Any other health problems you may have
- Your cancer type and stage
- Any other treatments you’ve had in the past
- How long it’s been since your last treatment
It can be disappointing if you don’t qualify for a particular trial but don’t give up hope if this is something you want. There are many trials available.
What if you’re not chosen?
Not everyone who applies to a clinical trial is chosen to participate. You may be turned down because you don’t meet certain criteria, or you’re not in the right age range or a specific gender. However, if you’re not chosen for a clinical trial, that’s okay. You’ll be recommended back to your specialist and given the option to apply to trials in the future.
What if you’re accepted?
If you’re accepted into a trial, your next step would be “informed consent”. The purpose of informed consent is to ensure that you understand the clinical trial’s protocol. The doctor or research nurse will go over the informed consent form with you, including the purpose, plan, risks, and benefits of the clinical research.
This is an excellent opportunity to ask questions. Bring a family member or friend to assist you in asking questions and writing down replies. If you choose to participate in the clinical trial, you will be required to complete an informed consent form. The doctor will sign the paperwork as well and give you a copy for your records.
Your informed consent form will include treatment plans (like who is eligible and the reason for the trial), risks and benefits, tests, potential costs, and any potential conflicts of interest. You’ll also get information about your privacy protection and who to call if you have questions.
The process of your informed consent doesn’t end when you sign the informed consent form. If new dangers or adverse effects of the treatment are discovered during the trial, your doctor must notify you. You can also ask any questions you may have throughout the trial.
Making A Decision
Take your time making your decision. You may take the informed consent form home with you to review before signing it if you choose.
People choose to engage in clinical trials for a variety of reasons. A clinical trial may be the greatest choice for some people. Because no normal treatment is flawless, patients are frequently willing to risk the additional uncertainty of a clinical trial in the hope of a better outcome. However, keep in mind that insurance coverage and clinical trial fees vary by location and program. Some of the costs associated with participation in a clinical study are paid in some programs, and in others, it’s not. It’s critical to consult with the research team and your insurance carrier to determine whether and how your treatment in a clinical study will be reimbursed.
Clinical Trial Phases
Now, let’s discuss the clinical trial phases themselves, and what they would mean for you as a participant.
Phase I
Phase I clinical trials provide the cornerstone for developing new cancer treatments and determining if a new treatment is safe in humans.
This trial’s purpose is to determine whether the treatment is safe, the best manner to administer the drug (by mouth or vein), and potential signals that the cancer responds to the new treatment.
This phase typically consists of 15 to 50 patients divided into small groups known as cohorts. The new medication is administered to the first cohort. Doctors then assess the patient’s medication levels. If the initial cohort does not have any serious adverse effects, the next cohort is given a greater dose of the same medicine. With each successive cohort, the dose is increased. This happens until the doctors determine the ideal amount for future trials. Doctors assess each patient with each increasing dose to see if they respond to the medication. If the doctors determine that the medicine is safe, it will be explored in a Phase II trial.
Phase II
Phase II of a clinical trial is used to test if the new treatment works in one specific type of cancer. These trials typically enroll less than 100 individuals. Even though the primary goal is to determine whether the medication is effective, doctors continue to constantly monitor patients’ side effects. If the new medication proves effective, doctors may move to Phase III.
Phase III
Hundreds to thousands of patients are enrolled in phase III trials, the most popular phase. Every patient in a Phase III clinical study has a possibility of being assigned to one of the following groups:
- The control group receiving the standard treatment (or a placebo)
- The study group receiving the new treatment that is being investigated
A computer determines which patients are in the control and study groups. Patients can be assigned to either group. The patient and doctor do not make the decision. This aids in the prevention of bias in clinical trials. Patients in single-blind studies have no idea whether they are in the control or study group, but the doctor does. In a double-blind study, neither the patients nor the doctors know who is in which group.
When a placebo is given, it is combined with the best standard treatment available. This allows doctors to compare routine treatment to the new medicine on its own. If no standard treatment is available, the placebo may be administered alone; however, this is uncommon in cancer trials.
The FDA evaluates the clinical trial results following the Phase III trial to ensure that the medication is safe and effective for individuals to use. The FDA decides whether the medicine should be approved so that it’s available to all patients.
Phase IV
Phase IV trials are the last part of a clinical trial, but these are usually employed to find out about any potential long-term side effects. In Phase IV, doctors will study the treatments that the FDA has already approved.
Clinical Trial Placebos
Placebos are inactive and harmless compounds that are designed to resemble the actual treatment used in the research trial. Placebos allow researchers to learn whether the therapy being tested works better or worse than standard treatment. Many studies have multiple time periods where either the placebo or the genuine drug is used. To avoid bias, the patient and, in certain cases, the staff are not told when or what the changes are. If a placebo is used in a study, you will always be notified in the consent form before agreeing to participate. And as a note, a placebo doesn’t mean you aren’t being treated at all, it simply means you are most likely not getting the new drug, but the standard drug.
How a Trial Can Affect You
If you’ve decided to be a participant in breast cancer trials, it’s important to understand the potential benefits and risks.
There are numerous potential advantages to participating in clinical research. Some of these include assisting scientists in better understanding your disease or condition in order to advance treatments, taking a more active role in your health, learning more about your condition, potential support groups and resources, and receiving a potential new disease treatment before it is widely available.
But of course, there are potential risks as well. This includes tests that pose a risk to participants, longer medical appointments, and potential hospital stays. Those who receive the experimental treatment may experience discomfort or adverse effects, it may not work as well as the normal treatment, or it may not work at all. Of course, if at any time you experience this and need to voice your concerns, you can do so.
Are clinical breast cancer trials a last resort?
Unfortunately, a frequent misconception exists that clinical trials are only used as a last choice for patients after all other forms of treatment have failed. However, participating in cancer care research can benefit patients at any stage of treatment and even potentially enhance care for future patients.
Yes, it’s important to note that some trials for some patients may be a last resort. But, there are also many trials that are used to provide better treatment, learn more about a condition, or provide a better quality of life for those with breast cancer.
Financial Resources for Clinical Trials
Depending on the clinical trial that you are a part of, you may get paid to participate. Or you may get coverage via your insurance or have to pay out of pocket. It’s important to ask the research team what potential costs would be and what’s covered before you start the trial.
There are many patient support resources that you may qualify for when attending a trial. And, if you need help with living expenses, travel expenses, or paying for lodging, there are many grants and programs available for that as well.
A clinical trial may also pay you for your participation. If they do, they may record pay of $600 or more to the IRS and issue you a “Form 1099-Other Income” at the end of the year. Please be advised that, under US law, the US Treasury may garnish any or all of your pay if you owe the federal government money. In this case, the US Treasury will tell you personally.
Breast Cancer Trials Wrap-Up
As you can see, there is a lot that comes with participating in breast cancer trials. However, with the right information and some advocacy, you can participate in one easier and be able to know more about your rights as a patient.