Advanced breast cancer clinical trial NCT07062965

Although there has been much progress in breast cancer therapies, sometimes treatments that once helped can stop working. That’s why more research is needed to help advance potential treatment options that may work better and keep working longer.

The Katsis-1 clinical trial is exploring a targeted treatment called a Kat6 inhibitor to learn if it may work better to slow the growth of cancer cells in people with HR+, HER2- advanced or metastatic breast cancer whose disease has gotten worse after previous treatment or stopped responding to treatment.

Joining a clinical trial is a personal decision. Thank you for taking the time to learn more.

Who may participate

This clinical trial may be an option if you:

Have HR-positive, HER2-negative breast cancer that has spread to other parts of your body
Have received 2 or fewer previous systemic treatments* for your advanced metastatic breast cancer
Previously received treatment with a CDK4/6 inhibitor, such as palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®)

*Systemic cancer therapy targets cancer cells throughout the whole body. Examples include chemotherapy, hormone therapy, and immunotherapy

There are other requirements that the study team will discuss with you.

Condition

HR-positive, HER2-negative locally advanced or metastatic breast cancer

Age

18+ years

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

If you choose to participate, you’ll review and sign a consent document and continue with the screening period. During the screening period, tests (such as a physical exam, tumor imaging, and blood sample collections) will be performed to confirm you meet all the required criteria and if this study is a good fit for you.

If you qualify and choose to participate, you’ll be assigned by chance to receive one of the 2 following combinations: 

The study medicine plus an approved medicine called fulvestrant
One of 2 currently approved treatments (either exemestane or fulvestrant) chosen by the study doctor for your type of breast cancer, plus an approved medicine called everolimus

You’ll continue to receive study treatment until imaging scans show that your cancer is getting worse, the study doctor thinks you’re no longer benefiting from the study treatment, you have side effects that become too severe, or you choose to stop taking part.

Your health and tumor growth will be monitored regularly by a team of breast cancer specialists during the study.

Length of study treatment

Depends on how your cancer responds, how well you tolerate the study treatments, and your personal choice

Number of study visits

About 2x per month, for the first 2 months, then about every 4-weeks

Long-term follow up

You’ll come back to the trial site about a month after your last dose so the study staff can check on your health. The study staff will contact you about every 3 months afterwards to continue to check on your health and disease status.

Tomorrow’s breakthroughs start today with you

Many factors, including genetics, race, age, and ethnicity, can impact how people respond to medication. That is why it is so important that clinical trials include people of all backgrounds. The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.

When you take part in a clinical trial like this one, you’re helping to represent your community and all people who are affected by HR-positive, HER2-negative advanced or metastatic breast cancer.