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This phase III interventional, randomized, open-label trial investigates the safety and efficacy of a new second-line treatment for advanced or metastatic breast cancer.
Treating advanced or metastatic breast cancer often requires promptly identifying the most effective treatment for each patient. We’re taking part in a study testing a new treatment option potentially with fewer side effects than chemotherapy for patients with a common type of breast cancer. This trial is available at MedStar Washington Hospital Center and MedStar Georgetown University Hospital.
About 70% of all breast cancers are hormone receptor positive (HR+), meaning they contain proteins that cause tumors to grow when they come in contact with the hormones estrogen or progesterone.
On average, about 6-10% of women with breast cancer are first diagnosed with advanced stage 4 disease. Our community members encounter obstacles such as limited access to timely care, lack of insurance, and insufficient education. Therefore, the experts in our cancer institute see higher rates of complex, advanced cancer at diagnosis.
A drug currently called PF-07220060, a new therapeutic developed by the study’s sponsor Pfizer, is being studied to give patients and providers another option. I’m excited about the potential for this medication to serve as an effective second-line treatment, helping more patients steer clear of chemotherapy while also slowing the progression of advanced breast cancer.
Learning more about treatment options.
Our study will enroll about 500 people nationwide who have already had a first-line treatment for HR+/HER2- advanced or metastatic breast cancer and have not had chemotherapy.
Half of the participants will take the PF-07220060 pill twice a day in addition to Fulvestrant, an injected therapy that shuts down cancer’s ability to receive estrogen.
The remaining half of the participants will get either fulvestrant alone, or a combination of two drugs, everolimus and exemestane. The groups will be carefully monitored, and their results will be compared to determine whether PF-07220060 is safe and effective.
Related reading: Advances in Breast Cancer Care Mean More Hope and Survivorship for Patients.
Exploring the potential of treatment with fewer side effects.
For most patients with HR+ metastatic breast cancer, treatment begins with a CDK4/6 inhibitor medication. This class of medicines targets proteins called cyclin-dependent kinases to interrupt cancer cells’ multiplication process.
The three CDK4/6 inhibitors approved for use impact people in diverse ways, with various side effects. All were approved less than ten years ago and have helped slow or stop breast cancer in many patients. While these drugs are well tolerated, they can sometimes cause low levels of white blood cells, called neutropenia, which can make patients more susceptible to infection. Researchers believe CDK6 inhibition is what makes people more likely to develop neutropenia.
These targeted therapies are usually paired with endocrine, or hormone, therapy to slow or stop tumor growth by stopping hormone production or blocking the hormones’ effect on cancer cells.
PF-07220060 is a new drug developed by Pfizer. It is a CDK4 inhibitor that does not inhibit CDK6, so this new drug could have less neutropenia than CDK4/6 inhibitors. That could allow patients to stay on an ideal dose longer. Earlier research suggests that this new drug provides at least 10 times more inhibition of CDK4 while minimizing side effects and limiting tumor growth.
Related reading: New Breast Cancer Research Seeks Community Insights to Facilitate Treatment Engagement.
Innovating for our patients.
Cancer researchers have the same goal: To find new, effective therapies with fewer side effects. Not every treatment works the same way for every patient. One person may metabolize a drug differently from another, and genetics and biology play a role in these differences. Enrolling participants from diverse backgrounds helps our research learn better how well the drugs work and what side effects they might have for different people.
At MedStar Health, clinical trials like this one and our broader collaboration with Georgetown’s Lombardi Comprehensive Cancer Center play an essential role in helping members of our community access cutting-edge treatments.
Our oncologists, surgeons, radiation oncologists, and support specialists work together to provide the best care for our patients, including identifying clinical trials that could benefit them. Studies like this help patients access advanced care.
Disclosure: Dr. Ami Chitalia reports having no personal financial interests related to the study.
