Clinical trials are an important step in finding new treatments for metastatic breast cancer. They can also help doctors identify the most effective treatments with the fewest side effects. 

Before joining a clinical trial, you need to be found eligible for that trial. Eligibility for metastatic breast cancer trials may be based on your stage of cancer, your type of breast cancer (e.g., HER2-positive), other treatments you have already tried, your age, or other factors. 

Before considering whether or not to participate in a metastatic breast cancer clinical trial, ask the researchers conducting the trial – and your doctors – the following questions so you know what to expect.

1. What is the purpose of this clinical trial? What is the drug or treatment being studied?

Some clinical trials are testing a new drug. Others may be focusing on a new drug combination or new use of an already approved drug.

With already approved drugs, certain potential side effects or contraindications may already be known. The new clinical trial may be exploring if that drug has other applications in treating metastatic breast cancer.

2. What phase is this trial?

There are four phases or steps of clinical trials. 

• Phase 1: This is usually the first clinical trial involving people. The drug is tested in a very small group, usually 15 to 30 subjects, who are closely monitored. The goal of this phase is to make sure the drug is safe, not if it is effective against breast cancer.  

• Phase 2: These trials are usually larger with slightly more people. Phase 2 trials look more closely at drug effectiveness. 

• Phase 3: Clinical trials in this phase focus on whether the new drug or drug regimen is more effective than other treatments for breast cancer. Phase 3 trials typically enroll more than 100 people and often last longer than phase 1 or 2 trials.

• Phase 4: A phase 4 clinical trial tests drugs that have already been approved by the FDA. The drug or drug regimen is tracked in hundreds or thousands of people to monitor long-term effectiveness and side effects. Phase 4 trials are less common than clinical trials in other phases. 

3. What types of tests, screenings, or medical visits will I need to have during the clinical trial? How often will I need to have them?

Participants in clinical trials are closely monitored by doctors and researchers. 

You may need regular laboratory tests (such as blood or urine), medical scans (CT scans, MRIs, etc.), or regular check-ins with healthcare professionals. This may involve an ongoing time commitment, potential travel to appointment or test sites, and other factors you will want to consider.

4. Has this treatment been tested before? If so, what were the results of those trials?

Depending on the phase of the trial, there may already be results available that can help inform your decision about whether to join the trial. For example, many side effects in a drug in a phase 4 clinical trial should already be known.

However, if clinical trials are being conducted at multiple test sites or are in early phases, results may not be available or finalized.

5. Are there any potential side effects that have already been determined? What side effects might I experience?

Earlier trials may have already shown an association of a drug with certain side effects. 

If the drug has previously been approved for a different use, potential side effects, their severity, and incidence rate may be known.

If you do experience side effects, you can find information in the Inspire Advanced Breast Cancer community. Many members have tips on how to manage drug-specific side effects. 

From the community: “I have just started a clinical trial based on immunotherapy. I feel weak and depleted. Doctor was concerned with thyroid function because of borderline levels last blood test. I'm losing weight weekly. My mood has been negatively affected. Does anyone have any feedback ,experience with this form of therapy Any encouragement would be helpful.” - Inspire member

6. How long will this clinical trial last? Under what circumstances might I leave the trial early?

Clinical trials often last for years. Be sure to find out how long a specific trial is scheduled to last. 

Also, some patients may not continue with the trial for the duration. Ask if side effects, tolerance to the drug, a change in medical condition, or other factors may affect whether a patient leaves the trial early.

7. How will being in this clinical trial affect my current standard of treatment? Will I have to stop my current treatment, or will this new treatment be in addition to my current treatment?

For many patients, this question is top of mind. Most of the time, participating in a clinical trial does not mean you won’t receive any other metastatic breast cancer treatment besides the drug being tested. 

Medical researchers are required to provide patients with a standard of care – also called “best practice” – treatment for their cancer. 

Placebos (sometimes called “sugar pills”) are not usually used in cancer clinical trials when a cancer patient would be at risk. So even if you’re in the control group, you will still receive standard treatment for metastatic breast cancer.

8. Are the costs of the clinical trial covered? What additional costs should I expect? Are those costs covered by my insurance or paid out of pocket by me?

Often, many of the costs of a clinical trial are paid for by the study. However, other costs may be expected to be covered by insurance. 

Find out before enrolling what costs the clinical trial will cover. Also ask about any unexpected out-of-pocket costs that may arise, such as parking or personal care supplies that may be needed.

9. How will this clinical trial affect my daily life?

A clinical trial can affect daily routines in different ways. 

For one, more frequent doctor visits or medical tests take time. You may also be advised to keep track of your everyday habits or any side effects you experience. 

If a drug has known interactions, you may be advised to discontinue with certain other supplements or medications, or not consume certain foods. 

From the community: “…I am on GDC-0077 plus Femara. Others are on different combinations. Some are on GDC-0077 plus Femara and Ibrance. I did not qualify for the three drugs because I had failed Ibrance. My blood sugar goes sky high if I eat any carbs. I am on three diabetic drugs. I lost 65 lbs. I have a lot of fatigue. I did not get mouth sores until cycle 13. Diarrhea is not bad. Being on the study has been difficult. I feel like I have aged ten years. I had a partial response which means my liver tumors shrunk but they did not disappear. My bone mets were stable. After cycle 15 I will have an MRI for the liver, and a CT scan for abdomen, chest...I will have an MRI of the spine to see what is going on there. It is so difficult waiting for these results. I have been lucky that this drug has worked for this long.” - Inspire member

10. How do I know if I’ve received the new treatment or if I’m in the control group?

Participants in a drug clinical trial are assigned to different treatment groups. 

One (or more) groups receive the new drug or drug regimen. A different group doesn’t get the new drug; instead, they receive the “standard of care” treatment (the treatment commonly used for metastatic breast cancer). 

Most of the time, clinical trial participants won’t know which group they’re in during the trial.

11. If the treatment works for me, can I continue to get it after the trial ends?

The doctors or organization conducting the clinical trial are not obligated to continue offering a treatment after the trial ends; however, access to the treatment may be possible. 

It’s best to find out what kind of continuing treatment is available before participating in the trial. 

For more information about clinical trials for metastatic breast cancer, visit ClinicalTrials.gov.

Sources

• What Are the Different Stages of Clinical Trials? BreastCancer.org. November 2015. 

• What Are the Phases of Clinical Trials? American Cancer Society. February 2017.

• NIH Clinical Research Trials and You: The Basics. National Institutes of Health. October 2017.

• Clinical Trials. National Comprehensive Cancer Network. 

• Clinical Trials for People with Metastatic Breast Cancer. Susan G. Komen. May 2020.

• Clinical Trials Information for Patients and Caregivers. National Cancer Institute.

Disclaimer

Member comments are lightly edited for length and to remove identifying information but are otherwise reproduced as they appear in the community as part of public posts.

This content is for general informational purposes only and does not necessarily reflect the views and opinions of any organization or individual. The content should not be used as a substitute for professional medical advice, diagnosis, or treatment. Please consult your healthcare provider about any questions you may have regarding a medical condition.