Seven Things People With Metastatic Breast Cancer Want You to Know About Joining a Clinical Trial

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by Jen Uscher 

By joining a clinical trial, you can potentially get access to a new, experimental treatment for metastatic breast cancer that isn’t otherwise available. You might even be among the first people to benefit from a drug that is more effective or has fewer side effects than standard treatments. 

But the uncertainty about how a clinical trial will turn out can make it hard to decide if you want to participate. You may be concerned that the experimental treatment has unknown side effects or carries other risks, and wondering if you’ll be able to handle the more frequent visits to the doctor and extra medical tests that trials typically require. 

As with any other treatment decision, you and your doctor need to weigh the possible benefits of enrolling in a clinical trial against the risks. It may also help to talk with other people with metastatic disease who joined clinical trials about their experiences. 

We asked members of the Community at Breastcancer.org who have participated in clinical trials for metastatic breast cancer to share the things they think are most useful to know before you enroll. Here are their insights: 

1. In some clinical trials, you could wind up receiving a standard FDA-approved treatment for metastatic breast cancer plus a placebo (sugar pill). 

If the trial that you join is a randomized, placebo-controlled trial for metastatic breast cancer, you’ll be randomly assigned to either a test group receiving an experimental medication or a control group receiving the treatment that is the current standard of care plus a placebo. This helps the researchers determine whether the new medication is safer and/or more effective than the standard treatment. 

In a double-blinded trial, neither the researchers nor the participants know who is getting the experimental medication and who is getting the standard treatment plus a placebo. Double-blinding helps prevent the researchers and participants from having expectations about what will happen and possibly biasing the results. 

You’ll always be able to find out before you enroll in a trial if there’s a possibility that you could receive a placebo (and if you won’t be able to learn whether or not you received the placebo). 

For example, when Breastcancer.org Community member Gramen decided to enroll in HER2CLIMB, a randomized, double-blinded clinical trial, she knew from the beginning that she could either wind up receiving Herceptin (chemical name: trastuzumab), Xeloda (chemical name: capecitabine), and the investigational medication tucatinib (ONT-380) or Xeloda, Herceptin, and a placebo. 

After 3 months, she had to drop out of the trial because she was having bad side effects and disease progression. 

“The biggest downside for me was that I wasn’t able to find out if I was given tucatinib or a placebo. I can’t base my future treatment decisions on that knowledge,” she says. “But I knew going into it that I wouldn’t be able to find that out.” 

2. You might find that you appreciate the increased medical attention and the close monitoring of side effects during a clinical trial. 

Typically, clinical trial participants are in more frequent contact with their medical team and can more easily get advice or other assistance. 

“I liked that during the trial, I had a direct line to the protocol nurses,” says Community member Denny123. “I could call them anytime during business hours. If I had a problem — like I developed a rash — I could talk with them about it right away.” 

Gramen found it helpful to have a trial coordinator as her main point of contact. The coordinator handled some tasks that patients often have to manage on their own when they’re not in a clinical trial.  

“She answered my questions, set up my appointments, and coordinated the delivery of my medications,” Gramen says. “My job was just to deal with the side effects and make it to the appointments. When you’re not in a trial, a lot of the scheduling and coordinating falls on you.” 

Gramen also liked that she had to fill out a diary to keep track of her treatment and side effects during the trial. 

“Each day, I recorded when I took the pills and the side effects I had,” she says. “It was helpful to see the patterns. I may keep a diary like that now that I’m starting a new chemo treatment (not as part of a clinical trial).” 

3. It’s best to learn as much as possible in advance about the schedule of the trial and any costs that might be involved. 

When you join a clinical trial, you agree to follow a specific schedule of visits to the clinic or hospital, medical tests and/or other procedures, and a schedule for taking medication. 

Community member Pajim recommends that you ask questions about the schedule of a clinical trial before you enroll so you know what to expect.  

“You may need to consider: am I prepared to go to the medical center for appointments every week for the first month and then every 2 weeks after that? If you have any trips out of town planned during the time the trial would be going on, you need to ask about how to handle that,” she says. 

Additionally, she suggests that you make sure you clearly understand what costs will be covered by the trial. Don’t assume that the trial will cover all the costs of your treatment, other medical care, travel, or other expenses during the study. 

“I didn’t ask the trial coordinators and my insurance company enough questions in advance about the costs,” she says. “I had a CT scan during the trial and I thought the costs for that would be covered by the trial. But it turned out that it was billed to my insurance as part of my ‘routine care’ and I was charged a co-pay. That bugged me.” 

4. During the screening process or during the trial itself, speak up if you’re concerned about some aspect of your care. 

Some people may find that some aspect of their care is not handled the way they expect during the screening process for a trial or during the trial itself. This happened to Gramen, who recommends you share your concerns and advocate for yourself when participating in a clinical trial. 

“There was a period of 7 or 8 weeks in which I stopped taking any cancer treatments while I completed the various things I needed to do as part of the screening process for the clinical trial, including getting a biopsy,” she says. “My doctor and I had been hoping the screening process would just take 2 or 3 weeks and that I wouldn’t have to stop treatment for such a long period. If I were to do it again, I would be more vocal and would try to push the trial coordinators to get the screening process over with faster. I can’t afford such a long waiting period with no treatment.” 

5. Remember that you can drop out (or “withdraw consent”) at any time.  

It’s important to keep in mind that you can opt out of a clinical trial at any time because you’re having bad side effects or the trial isn’t working out for you for any other reason. “You’re not locked in,” says Denny123. “In my case, I knew when I was having some severe reactions to a trial drug that I could have stopped taking it earlier than I did.” 

6. The experimental treatment you receive during a clinical trial could make a big difference in your health. 

The hope in joining a clinical trial is that an experimental drug will work well for you. While that isn’t always the case, many people do have success stories. 

Since she was diagnosed with stage IV de novo breast cancer in 2002, Denny123 has participated in two clinical trials, both of which she says were “miracles” for her. 

The first one was in 2004. 

“At the time, I had liver metastases — my liver was filled with tumors and the biggest one was the size of a baseball,” she says. “I enrolled in a trial in which I received Herceptin (chemical name: trastuzumab) and the chemotherapy drug Gemzar (chemical name: gemcitabine).” 

After receiving this treatment, she says her cancer went into remission and she had no evidence of disease for 7 years. 

“I felt like that trial saved my life.” 

In 2011, she then developed metastases in the lymph nodes in her chest, and in 2018, she enrolled in a second clinical trial of an experimental drug called poziotinib. 

“I wound up taking it for only 8 days because the side effects were so severe,” she says. “I had blisters on my lower face and scalp, oral thrush, severe mouth sores, and hair loss. My blood pressure tanked. I had to quit the trial early. The protocol called for taking the drug for 21 days. But apparently those 8 days of heck cleared my tumors. CT scans have showed that I’m in remission. Now I’m taking Xeloda and Herceptin to help keep me in remission. I would do that trial again even though it was nasty.” 

7. You may not regret participating in a clinical trial even if it doesn’t work out the way you hope. 

Experimental drugs won’t work for everyone, but you may find something positive to take away from the experience even if the treatment doesn’t work for you. 

Gramen, for example, ended up having disease progression during the clinical trial she enrolled in, but she says she learned from the experience and would consider participating in another. 

“It didn’t work out for me. But I still think clinical trials are a good option to potentially get access to a treatment that you couldn’t otherwise access,” she says. “I also liked that my first trial was a learning experience. I feel that I have to consider participating in other clinical trials in the future.” 

Similarly, Pajim says that she would join another clinical trial even though the two trials she enrolled in didn’t work out for her. 

“Even though I had adverse events that caused me to have to quit two clinical trials early on, I think clinical trials are great and I will enroll in one again,” she says. “There’s no way to know what will happen when you start, and it’s worth taking your chances.” 

Additionally, Pajim says she found it rewarding to participate in a clinical trial. 

“It makes me feel good to know that I’m helping the scientific process,” she says. “When you participate in a clinical trial, you’re helping the next generation of patients coming after you, and that’s really important.”  

To find out if there’s a clinical trial that’s right for your unique situation, talk with your doctor. You can also search for clinical trials by using the Metastatic Breast Cancer Trial Search tool or visiting ClinicalTrials.gov

For more information on the benefits and risks of clinical trials, how clinical trials are conducted, and what you should know before deciding to participate in one, visit Breastcancer.org’s Clinical Trials section.


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