Study of PF-07248144 and fulvestrant in adults with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who had progression after CDK4/6 inhibitor therapy
This study focuses on advanced/metastatic breast cancer that is hormone receptor-positive and HER2-negative. The study will test a new medication called PF-07248144 used together with fulvestrant in patients whose cancer has grown after previous treatment. This type of breast cancer depends on hormones to grow and has already spread to other parts of the body.
The treatment will involve taking PF-07248144 tablets by mouth along with fulvestrant injections into the muscle. Some patients will receive this combination, while others will receive different standard treatments such as everolimus or exemestane. The purpose is to determine if the combination of PF-07248144 and fulvestrant works better than currently available treatments in stopping the cancer from growing.
The study will last for up to 24 months. During this time, patients will have regular check-ups to monitor their health and see how well the treatment is working. Doctors will use special scans to measure if tumors are shrinking, staying the same size, or growing. They will also keep track of any side effects that patients may experience during the treatment.
1Initial assessment
Your eligibility for the trial will be confirmed through medical examination and review of your breast cancer diagnosis, which must be hormone receptor-positive and HER2-negative
You must be at least 18 years old and have advanced or metastatic breast cancer that cannot be treated with surgery or radiation therapy
Your previous treatments will be reviewed to confirm you have received prior CDK4/6 inhibitor therapy
A tumor tissue sample will be required for analysis
2Treatment assignment
You will be randomly assigned to one of two treatment groups:
Group A: You will receive PF-07248144 tablets taken by mouth plus fulvestrant given as an injection into the muscle
Group B: You will receive the investigator’s choice of therapy
3Treatment period
Your treatment will continue until your disease progresses or you experience unacceptable side effects
Regular assessments will monitor your response to treatment using imaging scans
Blood samples will be collected to measure drug levels in your body
Your health status and any side effects will be monitored throughout the study
4Follow-up period
After completing or stopping treatment, you will continue to be monitored for survival status
The study is expected to continue until January 2027
Your participation may end earlier if your disease progresses or you experience unacceptable side effects
Who Can Join the Study?
Must be at least 18 years old when joining the study
Must have confirmed HR-positive HER2-negative breast cancer that has spread locally or to other parts of the body (metastatic), and cannot be treated with surgery or radiation therapy alone
Must have previously received treatment with CDK4/6 inhibitor (a type of cancer medication) in one of these situations:
Combined with hormone therapy for advanced/metastatic breast cancer, or
As additional treatment with hormone therapy where cancer returned within 12 months after stopping CDK4/6 inhibitor
Must be able to provide a sufficient tumor tissue sample that has been preserved in a special way (FFPE tissue specimen)
Must have cancer that can be measured by scans, or cancer that only affects the bones
Must have good overall physical function, measured by ECOG Performance Status of:
0 (fully active) or
1 (restricted in physically strenuous activity but able to walk and do light work), or
2 (able to walk and care for self) may be considered if other health conditions are satisfactory
Who Cannot Join the Study?
Prior treatment with any CDK4/6 inhibitor (medications that block specific proteins involved in cell growth)
Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
History of other cancer types within the last 3 years, except for adequately treated non-melanoma skin cancer or cervical cancer in situ
Significant heart conditions, including:
Uncontrolled high blood pressure
Unstable heart rhythm problems
Heart attack within the past 6 months
Heart failure with symptoms
Severe liver problems or abnormal liver function tests
Known hypersensitivity (severe allergic reaction) to fulvestrant or any of the study medications
Participation in another clinical trial within 28 days before starting this study
Any serious medical condition that could interfere with study participation
Pregnancy or breastfeeding
Unable or unwilling to use effective contraception during the study period
Any psychological, social, or geographical condition that would prevent regular follow-up visits
PF-07248144 is an investigational medication being studied for treating breast cancer. It’s being tested in combination with other treatments in patients whose cancer has progressed after previous therapy. As this is a new drug in development, it’s currently known by its code name.
Fulvestrant is a hormone therapy medication used to treat breast cancer. It works by blocking the effects of estrogen, which can help slow or stop the growth of certain types of breast cancer cells. It’s commonly used in patients with hormone receptor-positive breast cancer.
Investigator’s Choice of Therapy (ICT) refers to standard treatment options that doctors may choose for their patients based on individual needs. This is not a specific medication but rather represents various established treatment options that may be selected by the treating physician.
Hormone Receptor-Positive HER2-Negative Breast Cancer – A type of breast cancer where cancer cells have receptors for estrogen and/or progesterone hormones but lack excess HER2 protein on their surface. This is the most common form of breast cancer, where tumor growth is driven by female hormones. The cancer begins in the breast tissue and can develop from cells lining the milk ducts or the milk-producing lobules. As it advances to metastatic stage, cancer cells can spread beyond the breast to other parts of the body through lymphatic system or bloodstream. The disease typically develops slowly compared to other breast cancer types.
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