Clinical trials are a vital part of the development of treatment in all cancers, including breast cancer, where clinical trials over the years have resulted in new drugs that prolong life and prevent cancer from spreading. Clinical trials are studies of new medications or treatments in humans before they are approved for widespread use.

As co-director of the Women’s Cancer Developmental Therapeutic Program at the University of Colorado Cancer Center, Jennifer Diamond, MD, helps oversee the introduction of new drugs for patients with breast and gynecological cancers. She also co-leads the Phase One, Expansion, and Molecular Studies (POEMS) research group, which is focused on early-phase clinical trials of new cancer drugs in patients with advanced cancer, including metastatic breast cancer.

We asked Diamond about how clinical trials work in breast cancer and why they’re important. 


How do breast cancer clinical trials typically start at the CU Cancer Center?

The majority of our breast cancer clinical trials are sponsored by a pharmaceutical company. A company has a drug it’s developing for a particular type of cancer, and they’ll invite us to participate in the study. We also have what are called investigator-initiated clinical trials, which are trials that begin in our laboratories. And then based on our research, we’ve designed a study and opened it here at the cancer center.

Are participants in breast cancer clinical trials patients who are already receiving treatment from us, or do patients seek us out specifically for the trials?

It’s different depending on what phase of study it is. The earliest phase of clinical trials are phase 1 clinical trials, which are designed to evaluate brand-new cancer drugs in patients with advanced cancer who have already received the standard available treatments and they’re not working well enough. These patients are often referred in from other oncology clinics in Colorado, and even from neighboring states, to look for a new option. Phase 2 and phase 3 clinical trials are designed to test the efficacy of a new cancer therapy. Many times, the new drug will be added to standard therapy, or we will do a randomized study where half of the patients get our usual standard of care and half of the patients will get that standard of care plus something new. Those later-phase studies might enroll patients who are newly diagnosed with cancer or maybe have just had a recurrence.

How much surveillance do participants typically require?

The main thing patients have to do if they’re participating in a clinical trial is come to the clinic more often. There could be extra visits where we’re monitoring for side effects of the medicine; there could be extra things like echocardiograms or other tests to make sure the heart function is normal. In general, we see patients once a week when they’re on phase 1 clinical trials. It’s less frequent for phase 2 and phase 3.

What have you seen clinical trials do for people? Are they potentially a game-changer for people with breast cancer?

If we look at breast cancer overall, there’s been a huge investment in clinical trials. A lot of that is due to patient advocacy and requests for money to be put into breast cancer research. Because of the sheer volume of clinical trials that have been conducted in breast cancer, we have many more active therapies compared to some other cancers. One direct impact of clinical trials is expanding treatment options for everybody with breast cancer.

The goal of clinical trials is to continue to develop more effective therapies, and as part of that, there’s always the hope that, “This therapy is going to work better than the last therapy, and it’s going to improve my prognosis or impact my quality of life.” The hope associated with clinical trials is really important, especially for late-stage patients. It can really be disheartening if their oncologist says there are no more treatment options. They may come to see us for a second opinion, and if we can offer them a clinical trial of something outside of the box, it provides a lot of hope.

Have the medications gotten better over the years as breast cancer researchers have learned more from other clinical trials?

Absolutely. We’re getting so much smarter in drug development. We’re learning more about people’s individual breast cancers—what markers might be on the surface of the cells, what mutations might be found inside of the cells—and we can match them to a targeted therapy that makes more sense than using a standard chemotherapy that is going to kill cells regardless of their subtype. There have been advances in targeted therapies for cancer, including breast cancer, and we are even starting to learn how to identify patients who are most likely to respond even in the earliest clinical trials.

When should someone start a breast cancer clinical trial?

Clinical trials can be considered at any point along a patient’s journey with breast cancer. A clinical trial might be appropriate as the first line of therapy or as a later-line therapy. Patients who are enrolled in clinical trials can often have a better prognosis, because they’re getting extra monitoring of their cancer. They’re being treated at the cutting edge, if you will. Clinical trials are generally designed to make sure we’re keeping up with all the science.

Do patients at the CU Cancer Center have more access to clinical trials than they might if they were at a community-based clinic?

The CU Cancer Center is the only National Cancer Institute (NCI)-designated Comprehensive Cancer Center in the state, allowing us to have access to many research studies that other clinics do not. Of the CU Cancer Center locations, the Anschutz Medical Campus has the most clinical trials available in breast cancer. But we also open some of our studies at our satellite centers, including Highlands Ranch, Lone Tree, and Cherry Creek. We’re working toward increasing access for patients treated at those locations and across the whole system of our clinical partner UCHealth, including Fort Collins and Colorado Springs.

Is there a specific focus area for our breast cancer clinical trials?

We have clinical trials for all types of breast cancer. We have a number of trials for triple-negative breast cancer, because it’s a breast cancer that still has fewer treatment options than many others. We also have active studies in HER2-positive cancers and brain metastasis.

How important is it to have diversity in our clinical trials?

It’s a huge focus at the CU Cancer Center, and it’s a huge focus nationally. The NCI has made it a priority to make sure we’re enrolling diverse patients into clinical trials. The reason this is so important is that we want to be confident that the results of these clinical trials will be applicable to the whole population, not just to certain parts of the population in the United States or across the world. It’s very important that we evaluate new drugs in populations of patients that match our catchment area (the state of Colorado). It’s also important for health equity—we want to make sure all patients have access to these treatments, regardless of race, ethnicity, and resources.

What is the best way for patients to find out if they are eligible for a breast cancer clinical trial?

It’s important that patients ask their providers if there are clinical trials they would be a candidate for. They should understand that sometimes there aren’t. Sometimes we may have a new standard of care therapy that was just approved, and that’s really the right thing for them. Along a cancer journey, there are times when a clinical trial is appropriate, and there are times when the standard of care therapy is the best option. It’s something that needs to be assessed over time.

What should patients know before they begin a clinical trial?

Patients should feel free to ask questions and make sure they really understand the purpose of the study — what the treatment is going to look like, what side effects they might experience — to make sure they’re comfortable. It should be a decision the patient and the provider are both comfortable with.  

Learn more about current breast cancer clinical trials at the CU Cancer Center and see if you qualify by visiting the clinical trials website.


This article was originally published October 10, 2023, by the University of Colorado Cancer Center. It is republished with permission.