A new generation CDK4 inhibitor study for people with HR+ HER2- breast cancer
Key Takeaways
- There is a need for more effective and better-tolerated treatments for people with HR+ HER2- metastatic breast cancer.
- HR+ HER2- breast cancer can become resistant to certain treatments.
- A phase III clinical trial currently enrolling patients at Providence Cancer Institute is evaluating a new medication called PF-07220060.
- This therapy could mark a shift in first-line breast cancer treatment options.
In the past couple decades, there have been significant improvements in breast cancer care and survival. Still, the need for a more effective and better-tolerated treatment for people with hormone receptor (HR)+ HER2- metastatic breast cancer persists. This type of cancer can be difficult to treat because it can become resistant to certain types of treatments.
A phase III clinical trial for people with HR+ HER2- breast cancer aims to address the challenge. The global study is currently enrolling participants at Providence Cancer Institute of Oregon. The trial is part of a broader push to develop targeted therapies that not only extend survival, but also improve patients’ quality of life, especially as metastatic breast cancer becomes a long-term condition for many people.
Study for HR+ HER2- breast cancer explained
While many patients with HR+ HER2- breast cancer respond well to initial endocrine therapy, it’s more challenging to treat cancer that has advanced or spread in the body (metastasized). Over time, tumors can develop resistance to standard treatments like CDK4/6 inhibitors, making it easier for cancer to metastasize.
But emerging CDK inhibitors are better able to target the molecular drivers that create resistance. The study at Providence Cancer Institute is looking at whether a new medication called PF-07220060 plus letrozole, works better and is better tolerated than CDK4/6i (investigator’s choice: palbociclib, ribociclib or abemaciclib) plus letrozole.
Unlike current CDK4/6 therapies, PF-07220060 is a highly selective CDK4 inhibitor. Early studies have shown it may be better at targeting cancer growth pathways. Letrozole is an aromatase inhibitor that lowers estrogen levels, which in turn can help slow or stop cancer cells from growing and spreading.
Why this study matters
For people with newly diagnosed metastatic HR+ HER2- breast cancer, choosing the right first-line therapy is critical. Most people start on a CDK4/6 inhibitor, but side effects like fatigue, low blood count and gastrointestinal issues can cause treatment delays or discontinuation. If PF-07220060 can reduce most side effects while also improving effectiveness, it could mark a shift in first-line treatment options.
Two-arm study design
The study is enrolling adults age 18 or older with confirmed HR+ HER2- advanced or metastatic breast cancer who have not received prior treatment.
Study participants will be randomly assigned to one of two groups. One group will receive PF-07220060 and letrozole (Arm A); the other group will receive the investigator's choice of treatment plus letrozole (Arm B). The study team will monitor each participant during regular visits.
Do you want to learn more about this study?
Providence Cancer Institute is offering this study at several sites in Oregon. The principal investigator is Alison Conlin, M.D., MPH, medical director, Providence Breast Cancer Medical Program and High-Risk Breast Cancer Clinic, Providence Cancer Institute.
To refer a patient:
- Call 503-215-1979
- Send an-email----