Outcomes4Me’s co-founder Maya Said sat down with a member of our medical advisory board, Dr. Sara Tolaney, to answer questions about clinical trials in breast cancer and what patients need to know. Dr. Tolaney is a breast oncologist at Dana-Farber Cancer Institute and the Associate Director of Susan F. Smith Center for Women’s Cancers. She is also the Director of Clinical Trials, Breast Oncology, and Assistant Professor of Medicine at Harvard Medical School.

We have included the entire video above for anyone who missed it and wants to watch it in full.  Here is a recap of the key takeaways from the discussion with Dr. Tolaney:

>> Let’s start off with clinical trials. What are the basics of clinical trials that patients need to know?

There are different types of clinical trials. Therapeutic trials (drug trials) are trying to understand an investigational drug and how it might work. Non-therapeutic trials are investigating something besides an investigational drug – such as how to improve quality of life or reduce the risk of recurrence through diet, nutrition, and exercise. 

There are three phases of clinical trials, known as Phase 1, 2, and 3. 

• Phase 1: This is where new drugs start being tested in people. Phase 1 trials are used to study the drug’s side effects, dosing, and sometimes efficacy of the drug. 
• Phase 2: These trials are looking to determine the efficacy, or how effective the investigational drug is.
• Phase 3: These trials are definitive studies that compare the new drug to standard-of-care drugs that we currently have. Phase 3 trials are looking to see if the new drug is superior in terms of dosing, efficacy, and limiting side effects. 

>> When is the right time to pursue a clinical trial? are clinical trials only for people that have exhausted all other treatment options?

There is a huge misconception about clinical trials – many people think trials are only available if you don’t have any other treatment options. The truth is: The right time to look into clinical trials is ANY time! We have clinical trials for all points in your treatment plan from prevention, to newly-diagnosed, all the way through treatment, recurrence, metastatic disease, and survivorship. 

It is important to consider a clinical trial any time you are making a treatment decision. Always ask “Is there a clinical trial for me?” While it is primarily the physician’s job to find you a clinical trial, you can be proactive and take charge of looking for trials on your own as well. 

You can find breast cancer clinical trials on clinicaltrials.gov and the Outcomes4Me app. There are also many other great resources out there for people to find a clinical trial suitable to them. 

>> What are the most exciting trials happening in breast cancer right now?

One really exciting thing for breast cancer patients is that there have been a ton of recent approvals for different subtypes of breast cancer. New drugs are becoming available to help people which is phenomenal.

Some exciting trial categories for breast cancer right now include:

• Targeted drugs: These drugs target a particular pathway on the tumor that can turn on cancer cells and drive the cancer to grow. One example of a targeted drug that was recently approved is alpelisib (Piqray), which is approved for certain patients with a PIK3CA mutation.
• Antibody-drug conjugates (ADCs): These drugs contain antibodies that attach to drugs with chemical linkers. By combining the antibody with the cytotoxic drug, ADCs allow targeted treatment towards the cancer cells. One example of a newly-approved ADC is Sacituzumab-govitecan (IMMU-132).
• Immunotherapy: Cancer can hide or “turn off” your immune system so that your immune cells can’t target and kill the cancer. Immunotherapy agents try to activate T-cells and allow the immune system to turn back on and kill the cancer. One example of an immunotherapy drug is atezolizumab (Tecentriq). 
• We also have clinical trials looking at novel chemotherapy options for breast cancer patients.

>> how do clinical trials work in terms of financial risks and benefits? will i get any benefit from research procedures like labs and biopsies?

In general, you will not get any financial benefits from joining a clinical trial. Because the investigational drug is being studied, you will receive the drug for free. However, all aspects surrounding the trial that pertain to care you would normally receive is billed to your insurance – this includes doctor visits, labs, and scans. If the trial requires additional procedures that are not considered standard-of-care, like research biopsies, research blood, or extra scans, then the trial will cover this cost. 

You will find out when you consent for a clinical trial about the study schedule and how often you will have visits, labs, and scans. This can help you plan for any financial costs you should expect to cover through your insurance while on the trial. 

Typically, patients will not see a direct clinical benefit from these research procedures. Samples collected like blood and tissue are analyzed in an anonymized way at the end of the trial. While the research may not directly benefit you, you will be contributing to research by helping doctors understand who will benefit from a certain treatment versus who won’t – and this can have a significant impact on future patients.  

>> How is the dose of a drug determined in a clinical trial?

Determining the best dose is tricky and not very straightforward. Its possible that sometimes we overshoot the maximum tolerated dose (MTD) in a trial. Classically, we test the dose of a drug in a “3+3” design. If 3 people get the new drug at a low dose and tolerate it well, 3 new people will take the drug at a higher dose to see if they also handle it well. This continues until we start to see side effects. 

Another way we can determine the best dose is by looking at data from blood and tissue specimens. We can look at the pharmacodynamics of the drug to see what dose hits the drug target at the best level. We often see that drugs can be dose-reduced and still hit its target with equal effectiveness and lower side effects. We struggle with this, but our goal is to ensure the effectiveness of the drug by giving a therapeutic dose while optimizing for side effects and quality of life. 

>>> how are clinical trials changing in response to the covid-19 pandemic?

COVID-19 has had a definite impact on clinical research. Clinical research requires a lot of staffing from doctors, PAs/NPs, nurses, clinical research coordinators, lab staff, pathology staff, regulatory coordinators, and more. It really takes an army. The challenge is providing safety to the staff and also managing the re-deployment of staff to alternate job roles. 

Right now (at DFCI), we are doing safety visits over the phone instead of in clinic, and in some cases, research drugs are being mailed to patients to reduce their exposure to the clinic. Certain parts of trials like research lab specimens are being halted. The pharmaceutical companies have been very good in working with us to ensure that the most important thing – that patients have access to their drugs – is still happening, even if it means that valuable research data is omitted. 

For the most part, trials are remaining open. However, depending on your geographical area and the resources of your hospital/cancer center, enrollment may be paused temporarily. Most places are trying their best to continue enrolling patients whenever possible. 

>> Do you think that there will be any adjustments in the way that clinical trials are conducted after having all of these adjustments during covid-19?

There are a lot of lessons that we have learned from COVID-19, as hard as it has been. I think that we can realize that some of our adjustments have been successful, such as more virtual visits, drugs delivered to patients’ homes, and less unnecessary procedures. 

These changes can have a huge impact on a patient’s quality of life. I hope that we will move towards better clinical trial operations and that maybe there will be a positive shift in trials after all of this. 

If you are looking for more support or questions or a specific type of resource, submit your question using the “ASK” tab in the Outcomes4Me app and our O4ME clinical care team will do their best to help you find an answer.

You can access more on the Outcomes4Me app here.