Entering the World of Clinical Trials

It's been a while, but it's worth the wait.

I had to let myself recover and focus on one day at a time. I am now 6 months post-chemotherapy. For the first time since I started chemotherapy on January 29. 2024, I feel like me. My energy is returning, my brain is firing, and I feel able to put some effort into more than just living. People are noticing I'm more like myself. All of this is positive, but I am still giving myself grace, because recovery isn't linear.

While I've been working on living, I was sent an email from Outcomes4Me about some clinical trials at the University of Pennsylvania. The article "Pioneering strategy may keep breast cancer from coming back" outlines current clinical trials at UPenn which focus on the chance of recurrence when there is a presence of dormant or disseminated tumor cells (DTCs) or "sleeper cells" in bone marrow and proposed treatment by existing medications already on the market. The article states, "'Our research shows that this sleeper phase represents an opportunity to intervene and eradicate the dormant tumor cells before they have the chance to come back as aggressive, metastatic disease,” Chodosh said. “Surprisingly, we’ve found that certain drugs that don’t work against actively growing cancers can be very effective against these sleeper cells. This tells us that the biology of dormant tumor cells is very different from active cancer cells.'"

I am considering participation in the SURMOUNT and ABBY clinical trials. 

In short, the SURMOUNT clinical trial "screens qualified patients for the presence of DTCs in the bone marrow" via a bone marrow aspirate. This occurs most commonly in the hip area of the pelvis and is known to be very painful. If positive for DTCs, the patient is then "offered enrollment into a clinical trial that targets DTCs to prevent recurrence". In this case, that would be ABBY. If negative for DTCs, the patient remains in the SURMOUNT study and a new bone marrow aspirate is taken every 6 months for 3 1/2 years unless it becomes positive. If it becomes positive within the 3 1/2 years, the patient would again, qualify for ABBY.

Example of SURMOUNT Clinical Trial Method

In the ABBY trial, the patient would take a study medication with the hopes of targeting the DTCs. The patient would be taking either abemaciclib (Verzenio) alone, or abemaciclib (Verzenio) with hydroxychloroquine. Once participants enroll in ABBY, they are required to have in-person provider visits every 28-days (+/- 3 days), so basically once per month for 6-12 months. Treatment is for 6 months (or six 28-day cycles). If the patient continues to be DTC positive after the 6-month bone marrow aspirate, they have the option to continue on treatment for 6 additional months.

Now here's the catch, these studies are located in Philadelphia, PA. 

How much is a life worth? If you watch Forensic Files, it can be for as little as $28. But really, what a moral dilemma between the potential to prevent recurrence of my breast cancer and the time and money it will take to get to the clinical trials. I know the potential benefits of participating are not just my own, but for the future of breast care treatments. It took many pioneers before me to be clinical trial participants to ensure I had the correct chemotherapy, radiation, and surgery for best possible results. 

The Facts (with a reminder that my breast cancer was HER2+ and HR+ or triple positive):

• Triple negative (HER2- and HR-) and HER2+ breast cancers have a higher risk of recurrence and often recur within the first few years (within 5 years).
• HR+ breast cancers have a higher risk of late recurrence (after 5 years).
• Of note, there are many other factors that increase (or decrease) the risk of recurrence but the study focuses on the receptor status so we'll keep it simple.
• So far, in the SURMOUNT study, 90% of patients have negative DTCs while 10% have positive DTCs and are referred to a treatment trial, such as ABBY.
• Abemaciclib (Verzenio) has the following side effects:
• Diarrhea
• Nausea
• Risk of Infections
• Low red blood cell counts (anemia)
• Decreased appetite
• Headache
• Hair thinning or hair loss (alopecia)
• Abdominal pain
• Tiredness
• Low white blood cell counts (leukopenia)
• Vomiting
• Low platelet counts (thrombocytopenia)
• Hydroxychloroquine has the following side effects:
• Nausea
• Vomiting
• Stomach cramps
• Diarrhea
• Loss of appetite
• Headache
• Dizziness
• Fatigue
• Irritability
• Hair loss
• Rash
• Itching
• Changes in skin or hair color (including white spots or dark patches)
• Mild muscle weakness. 

So the question therein lies, do I feel these same side effects as chemotherapy now, if I'm positive for DTCs, and add to the future treatment options for breast cancer, or do I wait to see IF I have recurrence and get treatment with likely the same side effects as above IF and when that occurs?

As mentioned by my loved ones, ultimately, the decision is up to me.