A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.
This research study is looking at two new medications, vepdegestrant and PF-07220060, for people with advanced or metastatic breast cancer. This means the cancer has spread from the breast to other parts of the body and hasn't responded well to previous treatments. The main goal is to find out if taking these two medicines together is safe and if they can help treat this type of cancer. The study will also see how the body handles these medicines. Participants will take both medicines by mouth at home and have regular check-ups at the clinic. The study will continue until the cancer no longer responds or if side effects become too strong. This is an important step to find better ways to treat breast cancer.
At a glance
What is this study about?
This study, called C4891026, is an important research project looking into new ways to treat advanced breast cancer. When breast cancer is described as 'advanced' or 'metastatic', it means it has spread from where it started in the breast to other parts of the body. Unfortunately, for some people, their cancer stops responding to usual treatments. This study is for people in that situation.
The researchers are particularly interested in breast cancer that is 'estrogen receptor positive' (ER+). This type of cancer often grows because of the hormone oestrogen. The study will test two new medicines, vepdegestrant and PF-07220060, taken together. The aim is to see if this combination can be a safe and effective treatment when other medicines haven't worked or stopped working. Both medicines are taken by mouth, which can be more convenient for patients.
This study is being conducted in two parts, called Phase 1b and Phase 2. In Phase 1b, the main focus is on the safety of the new medicines and how they are handled by the body. In Phase 2, if the medicines seem safe, the study will look more closely at how well they work against cancer. By taking part, you would be helping doctors and scientists learn more about advanced breast cancer and potentially find new, more effective treatments for others in the future.
Key takeaways
- Tests new medicines for advanced breast cancer that has spread.
- For 'estrogen receptor positive' (ER+) cancer that's no longer responding to previous treatments.
- Medicines are taken by mouth at home.
- Regular clinic visits (about once a month) for monitoring.
- Aims to find out if the new treatment is safe and effective.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would need to have breast cancer that has been diagnosed by medical tests. Your cancer must have spread to other parts of the body and cannot be completely removed by surgery. It also needs to be sensitive to hormone therapy, meaning it's 'estrogen receptor positive', and should no longer be responding to your previous treatments.
You would also need to be at least 18 years old. Importantly, if you've had previous treatments, there are specific rules about how many types of treatment you've received before. Your general health and how well you can carry out daily activities will also be checked by the study doctors.
There are also reasons why you might not be able to join. For example, if your cancer is causing a life-threatening emergency, or if you have certain heart problems. If you have active brain tumours or other types of cancer diagnosed recently, you might not be able to participate. Also, if you can't properly absorb medicines, or are taking certain other medications or herbal supplements, it might affect your ability to join.
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.
- Do I have advanced or metastatic breast cancer?
- Is my breast cancer 'estrogen receptor positive' (ER+)?
- Is my current breast cancer no longer responding to previous treatments?
- Am I at least 18 years old?
- Do I have any serious heart problems or active brain tumours?
What does participation involve?
If you decide to take part in this study, you would take both study medicines, vepdegestrant and PF-07220060, by mouth at home. You would continue taking them until your cancer starts to grow again, or if you experience side effects that are too uncomfortable or serious.
You will have regular check-ups at the study clinic, typically about once every four weeks. During these visits, the medical team will monitor your health, check for any side effects, and see how the treatment is affecting your cancer. They will also carry out various tests, which might include blood tests, scans, and physical examinations. The total duration of your participation will depend on how you respond to the treatment and your tolerance to any side effects.
Potential risks and benefits
Locations (58)
- Highlands OncologyVerified postcodeFayetteville, United States
- Highlands OncologyVerified postcodeRogers, United States
- Highlands Oncology GroupVerified postcodeSpringdale, United States
- Hoag Health Center IrvineVerified postcodeIrvine, United States
- Hoag Hospital IrvineVerified postcodeIrvine, United States
- Hoag Memorial Hospital PresbyterianVerified postcodeNewport Beach, United States
- Stanford Cancer CenterVerified postcodePalo Alto, United States
- Stanford Cancer Institute - Clinical Trials OfficeVerified postcodePalo Alto, United States
- Stanford Women's Cancer CenterVerified postcodePalo Alto, United States
- UCSF Medical Center at Mission BayVerified postcodeSan Francisco, United States
- UCHealth Poudre Valley HospitalVerified postcodeFort Collins, United States
- UCHealth HarmonyVerified postcodeFort Collins, United States
Common questions
What type of breast cancer is this study for?
This study is for advanced or metastatic breast cancer that is 'estrogen receptor positive' (ER+) and has stopped responding to previous treatments.
How will I take the study medicines?
Both medicines, vepdegestrant and PF-07220060, will be taken by mouth at home.
How often will I need to visit the clinic?
You will have clinic visits about once every four weeks to monitor your health and the treatment's effects.
What happens if the medicines don't work for me?
You would stop taking the study medicines if your cancer starts to grow again or if side effects become too severe.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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