A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
This study is looking at a new medicine called PF-07248144, taken as a tablet, alongside an existing treatment, fulvestrant, given as injections. It's for people in the UK with advanced breast cancer that is positive for hormone receptors (HR-positive) and negative for a protein called HER2 (HER2-negative). This type of breast cancer grows with hormones like oestrogen. The study is for those whose cancer has worsened after prior treatment, particularly a type called CDK4/6 inhibitor therapy. Researchers want to compare the new combination to standard treatments like everolimus and exemestane, to understand if PF-07248144 plus fulvestrant is safe and works well to treat the cancer.
At a glance
What is this study about?
This study is exploring a new tablet medicine, PF-07248144, to treat a specific type of breast cancer. It's for people whose HR-positive, HER2-negative advanced or metastatic breast cancer has continued to grow even after they've had other treatments. HR-positive means the cancer cells are driven by hormones, and HER2-negative means they don't have a lot of a protein called HER2.
Advanced cancer usually means the cancer is unlikely to be cured, while metastatic means the cancer has spread from where it started to other parts of the body. The new medicine will be given alongside an existing treatment called fulvestrant. The main goal is to find out if this combination is safe and if it can help stop the cancer from growing.
Researchers will compare the experiences of people receiving the new combination with those who receive standard treatments that are already used for this type of breast cancer, like everolimus and exemestane. This comparison is important to understand if the new treatment is a good option for future patient care.
Key takeaways
- Tests a new tablet medicine (PF-07248144) alongside an existing injection (fulvestrant).
- For HR-positive, HER2-negative advanced breast cancer that has progressed after previous treatment.
- Compares the new combination to standard treatments like everolimus and exemestane.
- Aims to check safety and effectiveness of the new treatment.
- Participation involves regular clinic visits for injections and monitoring.
Who may be eligible?
This study is looking for adults aged 18 and over who have been diagnosed with HR-positive, HER2-negative breast cancer that has grown or spread and can't be removed by surgery or treated with radiotherapy to cure it.
To join, your breast cancer must have worsened after you've already had a specific type of hormone therapy called CDK4/6 inhibitor therapy. You might still be able to join if you've had other hormone treatments or if you've had certain gene changes treated. Your general health and how well you can perform daily activities will also be considered.
Some reasons you might not be able to join include having certain detectable changes in your tumour cells (like PIK3CA/AKT1/PTEN), having had more than two previous treatments for advanced cancer, or if you've had chemotherapy for advanced cancer. You also wouldn't be able to join if you have serious kidney, liver, or blood problems, or any other health condition that might make participating in the study risky.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have HR-positive, HER2-negative advanced or metastatic breast cancer?
- Has your cancer progressed (gotten worse) after a previous treatment called CDK4/6 inhibitor therapy?
- Do you have good general health and are able to perform daily activities as usual?
- Have you not had more than two previous treatments for advanced cancer?
- Are you free from severe kidney, liver, or blood problems?
What does participation involve?
If you join this study, you will either receive the new medicine PF-07248144 with fulvestrant, or a standard treatment (everolimus with either exemestane or fulvestrant). PF-07248144, everolimus, and exemestane are all tablets you would take at home every day. Fulvestrant is given as two injections into your buttocks during clinic visits.
Medicines are taken in 28-day cycles. You'll have regular visits to the study clinic for injections, check-ups, and to see how you're responding to the treatment. These visits will involve various assessments, which might include blood tests, scans, and physical examinations. The total duration of your participation in the study, including follow-up, will be explained by the study team.
Potential risks and benefits
Locations (202)
- Ironwood Cancer & Research CentersVerified postcodeChandler, United States· Recruiting
- Ironwood Cancer & Research CentersVerified postcodeGilbert, United States· Recruiting
- Ironwood Cancer & Research CentersVerified postcodeGlendale, United States· Recruiting
- Ironwood Cancer & Research CentersVerified postcodeGoodyear, United States· Recruiting
- Ironwood Cancer & Research CentersVerified postcodeMesa, United States· Recruiting
- Ironwood Cancer & Research CentersVerified postcodeMesa, United States· Recruiting
- Ironwood Cancer & Research CentersVerified postcodePhoenix, United States· Recruiting
- Ironwood Cancer & Research CentersVerified postcodeScottsdale, United States· Recruiting
- Ventura County Hematology Oncology SpecialistsVerified postcodeCamarillo, United States· Not yet recruiting
- Los Angeles Cancer Network - (Admin Only / Central IDS) - No PatientsVerified postcodeGlendale, United States· Not yet recruiting
- Los Angeles Cancer Network - Good SamaritanVerified postcodeLos Angeles, United States· Not yet recruiting
- Los Angeles Hematology Oncology Medical GroupVerified postcodeLos Angeles, United States· Not yet recruiting
Common questions
What does HR-positive, HER2-negative mean?
It describes your cancer cells. HR-positive means hormones like oestrogen can make the cancer grow. HER2-negative means the cancer cells don't have a lot of a specific protein called HER2.
What is 'advanced or metastatic breast cancer'?
Advanced means the cancer is unlikely to be cured. Metastatic means the cancer has spread from your breast to other parts of your body.
What is a CDK4/6 inhibitor therapy?
It's a type of medicine that targets specific proteins to help stop cancer cells from growing. This study is for people whose cancer has grown even after this kind of treatment.
Will I definitely get the new medicine?
No, half of the people in the study will receive the new medicine combination, and the other half will receive standard treatments already used for this type of cancer.
How often will I need to go to the hospital?
You'll have regular visits to the study clinic for injections (if part of your treatment) and check-ups, including blood tests and scans, typically in 28-day cycles of treatment.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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