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I was diagnosed 7 years ago on June 6, 2013 with Inflammatory Breast Cancer. This is a very rare form of Breast Cancer. With given an only 20% chance to live, I sought out the best options. My breast surgical oncologist offered me a chance to save my life………………. participation in a new breast cancer clinical trial. What did I have to lose??

QUESTIONS TO ASK YOUR DOCTOR??

These are some of the questions you may want to ask your doctor about a trial you are interested in or that your doctor has recommended:

The Breast Cancer Trial
• What do you know about this trial?
• Do you have other patients who have enrolled in this trial?
• What would my treatment be if I didn’t enter the trial?

The Trial’s Risk and Benefits
• What type of side effects might I experience?
• Are there treatments to alleviate side effects?
• Are there any potential long-term risks?
• How will the trial and its possible side effects affect my daily life?
• What are the benefits of participating in a clinical trial?

The Trial’s Participation Requirements and Care
• What tests, procedures, and treatments will I have during the trial?
• Will I still see you – my own doctor – on a regular basis?
• Who will monitor my care and safety?
• Can I discontinue the trial at anytime?
• If I discontinue the trial will I still receive the same standard of care?

My Personal Thoughts on Participating in a Breast Cancer Clinical Trial

• My treatment plan was individualized (standard of care plus clinical trial drug).
• I could stop my breast cancer trial at any time and still receive the standard of care.
• I was helping physicians identify new cures for Breast Cancer.

Source: National Cancer Institute

With only 5% of the population participating in a clinical trial, you are not only enhancing your own treatment and improving survivorship but you are helping physicians identify new cures for Cancer. Also, you will get to an opportunity to experience the value of personalized medicine through the benefits of an individualized treatment plan.

What’s It Like to Be in a Clinical Trial?

Here is what you need to look for:

Informed consent or informed permission
• The people running the clinical trial must get your written, informed consent before you take part in any way.
• In the informed consent process, the researchers (doctors or nurses) will explain the details of the study to you and answer your questions and concerns.

You will then be given a written consent form to sign. Here is what should be include:
• The reason for the study.
• Who is eligible to take part in the study.
• What’s known about the new type of treatment.
• The possible risks and benefits of the new treatment.
• Other treatments that may be an option for you.
• The design of the study (whether it’s randomized, double blinded, etc.)
• How many and what types of tests and doctor’s visits are involved.
• Who must pay for the costs of the clinical trial.
• A statement about how your identity will be protected.
• A statement about the voluntary nature of the study and your right to leave the study at any time.
• Contact information in case you have questions at any time before and during the study.
• Before you sign the consent form, ask questions.
• Be sure someone from the research team goes over the form with you.
• Finally, don’t feel rushed into making a decision.

Taking part in the study
• Once you’ve signed the consent form, you’ll be ready to take part in the study
• You’ll probably need to have blood tests and/or imaging tests done before you start treatment.
• A full medical history is taken and a physical exam is usually done. These are needed before you start the study to be sure that you meet the eligibility criteria and to help ensure your safety.
• You may have tests done more often to find out how well the treatment is going and to look at how you’re doing. • You’ll likely get more attention as a study participant than you would otherwise.
• The doctors and nurses may examine you more often and will want to know if you’re having any side effects (called adverse events) while being treated.

What if I want to leave the study early?

You will be told many times before you enter the study that taking part in the study is always voluntary. This is an important point. You may quit taking part in the study at any time and for any number of reasons:

• You complete treatment on the study
• The treatment doesn’t seem to be working for you
• You have serious side effects while in the study
• You decide to leave the study

Clinical Trials exist for patients at any step of their cancer journey; trials are a part of the continuum of care. None of the advances in breast cancer could have happened without patients volunteering to be in trials. Source:

National Cancer Institute

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