Clinical trials for metastatic breast cancer


When you talk with your healthcare team about treatment for metastatic breast cancer, ask about clinical trials. A clinical trial gives you access to treatments that may be effective but are not yet approved by the FDA.

In most cases, new anti-cancer treatments are used in clinical trials for people with metastatic breast cancer before they are used in people with early-stage disease. Many allow you to join the trial even if you’ve been treated with other cancer treatments in the past.

Now is the right time for clinical trials

Clinical trials are not a last resort. If your providers suggest one, it doesn’t mean they have given up.

Sometimes it’s better to enroll in a study before you start other standard treatments, because some trials only allow people who have not taken certain medicines in the past. Joining a clinical trial before you try other treatments may give you more options over a longer period. But you are still likely to find available clinical trials, even if you have progression of disease over time.

Even if the trial medicine doesn’t work for you, you may still have standard medicines to go back to.

Clinical trials in metastatic breast cancer

In metastatic breast cancer, clinical trials compare standard FDA-approved treatments to new therapies, or they study new therapies. All of today’s standard therapies for stage IV breast cancer were once part of clinical trials.

Many ongoing and future trials in metastatic disease are designed to treat specific subtypes of breast cancer, such as hormone receptor-positive, HER2-positive, and triple-negative. Other studies are testing how treatments already in standard use for other types of cancer work in metastatic breast cancer and seek FDA approval from the results.

In a clinical trial, you will always be treated with medicine when a standard treatment exists. You would not receive just a placebo, an inactive pill, unless there is no standard treatment option available for you. In large clinical trials where there are standard treatments, you would get either:

  • The standard treatment alone
  • The standard treatment plus the treatment under study
  • The standard treatment plus a placebo

Sometimes in smaller clinical trials, you may just receive the treatment under study. The goal is to see whether the study treatment is effective or, in some cases, just to see whether it’s safe.

Taking part in a clinical trial will not make you a “guinea pig” or “lab rat.” The researchers who run clinical trials are working to prove their treatment is effective and safe. They want you to be as well as possible. There are also national laws that protect you during a clinical trial.

How will I get treatment?

When you enroll in a clinical trial, your doctor might be part of the study, so your care will remain in the same place. If not, you will work with a different doctor and might have to travel to another clinic. Before you enroll, you will receive information about where and how you will get treatment. The doctor leading the trial will send updates on your care to your original doctor.

Taking part in a clinical trial is often similar to receiving treatment outside a trial. You will have a medical team, with a doctor responsible for your care. You’ll also be assigned a clinical trial coordinator to answer your questions and address your concerns. In some cases, your trial medicine can be given at your own treatment center, so you can continue to see the care team you already have.

During your treatment in a clinical trial, your team will talk with you regularly about any discomfort or side effects you experience and how you feel overall, as well as watch the progress of the cancer. You can also contact them anytime to report symptoms and talk about how to relieve them.

Sometimes clinical trials cost little for participants, helping you get treatments that are expensive or that aren’t covered by your insurance. In other cases, you may need to pay for parts of treatment that you would have received outside the trial, like routine check-ups. There may also be travel expenses. Talk with the trial nurse about costs and resources for help.

Finding trials

To learn more about clinical trials, talk to your doctors. Because trials usually focus on very specific types of breast cancer, guidelines to enroll are strict and may be based on your prior treatments, type of cancer, age, and other factors.

In addition to general clinical trials resources, you can find clinical trials at Metastatic Trial Search, powered by This is a trial search engine designed specifically for people with stage IV breast cancer. It allows you to search by age, zip code, gender, breast cancer subtype, and even sites of metastasis.


Reviewed and updated: August 31, 2015

Reviewed by: Pallav K. Mehta, MD


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