C4391025_AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING
This research study is for women who have gone through menopause and have a certain type of breast cancer, called 'hormone receptor-positive, HER2-negative.' This means their cancer growth is affected by hormones and doesn't have too much of a protein called HER2. The study aims to see if adding a new drug, called PF-07220060, to a standard treatment, Letrozole, works better than Letrozole alone. The main goal is to find out if this new combination can help shrink the cancer more effectively before surgery. Researchers will also be checking for any side effects and how well patients tolerate the new drug. It's a 'Phase 2' study, which means it's still in the earlier stages of testing new treatments to understand their effects.
At a glance
What is this study about?
This study is designed for women who have already gone through menopause and have a particular kind of breast cancer. This type is referred to as 'hormone receptor-positive' because its growth is often influenced by hormones in the body, and 'HER2-negative' because it doesn't have an excess of a specific protein called HER2. In this study, doctors are looking at a new drug, called PF-07220060, and how it works when given alongside a more common breast cancer medicine, Letrozole.
The idea is to give these medicines before surgery, a treatment approach sometimes called 'neo-adjuvant therapy'. The main aim is to see how much the cancer shrinks or changes after a short period of treatment. By giving treatment before surgery, doctors can see how the cancer responds to the medications. This study will compare the new combination therapy (PF-07220060 plus Letrozole) against Letrozole alone, to understand if the new drug adds a benefit.
This is a 'Phase 2' study, which means it's an important step in researching new treatments. It's designed to explore if the new drug is safe and effective enough to be studied further in larger trials. The information gathered from this study will help doctors understand more about this specific type of breast cancer and how best to treat it.
Key takeaways
- This study is testing a new drug for specific breast cancer before surgery.
- It's for women who have gone through menopause.
- It aims to see if adding the new drug improves cancer shrinkage.
- Researchers will also collect important safety information.
- Participation involves taking medication and regular medical checks.
- You can stop participating at any time.
Who may be eligible?
This study is looking for women who have gone through menopause. You need to be at least 18 years old to take part.
You must have been diagnosed with a specific type of breast cancer. This is called 'hormone receptor-positive' and 'HER2-negative' breast cancer. Your doctor will be able to confirm if your cancer fits this description.
The researchers will have other detailed rules about who can join to make sure the study is safe and that they can get clear results. Your specialist doctor will discuss all the specific criteria with you to see if this study could be an option.
- I am a woman who has gone through menopause.
- I am 18 years old or older.
- I have been diagnosed with hormone receptor-positive, HER2-negative breast cancer.
- My doctor has confirmed I meet all other specific study requirements.
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive either the new drug (PF-07220060) alongside Letrozole, or Letrozole on its own. It's an 'open-label' study, which means you and your doctor will know which treatment you are receiving. Before starting, and at certain points during the study, you'll have specific tests, including blood tests and possibly a small tissue sample (biopsy) taken from your breast.
The main focus of checking how the treatment is working will be around two weeks (Day 14) after you start. Researchers will look at how the cancer cells are changing. During the study, you will have regular clinic visits to monitor your health, check for any side effects, and ensure you're tolerating the medication well. The total duration of your participation in the study medication phase is relatively short, as the treatment is given before surgery, but there might be follow-up appointments.
Potential risks and benefits
Locations (8)
- —Italy
- —Spain
- —France
- —Slovakia
- —Germany
- —Sweden
- —Poland
- —Belgium
Common questions
What does 'hormone receptor-positive, HER2-negative' mean?
This describes a specific type of breast cancer where the cancer cells grow in response to hormones, and they do not have high levels of a protein called HER2.
What is Letrozole?
Letrozole is a standard medicine often used to treat hormone-sensitive breast cancer in women who have gone through menopause.
What does 'neo-adjuvant' mean?
It means the treatment is given before surgery, to try and shrink the cancer first.
Will I know if I'm getting the new drug or just Letrozole?
Yes, this is an 'open-label' study, so you and your study doctor will know which treatment you are receiving.
What is a 'Phase 2' study?
Phase 2 studies are early-stage trials that aim to see if a new treatment is safe and shows enough promise to be studied further in larger groups of people.
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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