All studies
RecruitingPHASE3INTERVENTIONAL

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

Status
Recruiting
Phase
PHASE3
Sponsor
Pfizer
Enrolment target
400
Start
05 Aug 2025
Estimated completion
04 Nov 2030

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.

  1. Are you 18 years old or older?
  2. Do you have HR-positive, HER2-negative advanced or metastatic breast cancer?
  3. Has your cancer progressed (gotten worse) after a previous treatment called CDK4/6 inhibitor therapy?
  4. Do you have good general health and are able to perform daily activities as usual?
  5. Have you not had more than two previous treatments for advanced cancer?
  6. Are you free from severe kidney, liver, or blood problems?
Answer every question to see your result.

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

Taking part in any medical study has potential benefits and risks. For some people, this study might offer a chance to try a new treatment that isn't yet widely available, which could potentially help manage their cancer. However, the new medicine may also cause side effects that we don't fully understand yet. Your doctors will carefully monitor you for any problems. You will be given more detailed information about possible side effects before you decide if you want to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual care.

Locations (202)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Ironwood Cancer & Research Centers
    Verified postcode
    Chandler, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Gilbert, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Glendale, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Goodyear, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Mesa, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Mesa, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Phoenix, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Scottsdale, United States· Recruiting
  • Ventura County Hematology Oncology Specialists
    Verified postcode
    Camarillo, United States· Not yet recruiting
  • Los Angeles Cancer Network - (Admin Only / Central IDS) - No Patients
    Verified postcode
    Glendale, United States· Not yet recruiting
  • Los Angeles Cancer Network - Good Samaritan
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • Los Angeles Hematology Oncology Medical Group
    Verified postcode
    Los 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?

Register your interest

Share your details and the research team for "A Study to Learn About the Study Medicine Called PF-07248144…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.