FourLight-1 is a phase 3 clinical trial to learn if a study medicine (known as PF-07220060) combined with fulvestrant can improve outcomes in people with hormone receptor 
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

If your cancer has worsened during or after treatment with CDK4/6 inhibitor-based therapy, you may want to consider participating in the FourLight-1 clinical trial. Participants will have the support of a caring team of healthcare professionals and may also contribute to the discovery of a breakthrough treatment that could help others with advanced breast cancer.

Who may participate

Joining a clinical trial is an important and personal decision. Thank you for taking the time to learn more about the FourLight-1 clinical trial.

This study is enrolling adults with advanced or metastatic HR-positive, HER2-negative breast cancer that has worsened after treatment with one of the following CDK4/6 inhibitors in combination with either letrozole or anastrozole:

  • Palbociclib (IBRANCE®)
  • Ribociclib (KISQALI®)
  • Abemaciclib (Verzenio®) 

Other criteria may apply, which the study team will discuss with you. To see if you may be eligible to participate, click “Get Started” and answer a few questions.

If you don’t meet the requirements for this study, click here to learn more about other Pfizer breast cancer research opportunities.

Condition

HR-positive, HER2-negative advanced or metastatic breast cancer

Age

18+ years

Sex

Female or Male

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the clinical trial.

What to expect

If you choose to participate, you will sign the consent document and continue with the screening period. During the screening period, tests (such as a physical exam, electrocardiogram, imaging scans, and blood sample collections) will be performed to confirm whether you meet all eligibility criteria. 

If you qualify for FourLight-1 and choose to participate, you will be randomly assigned to a treatment group (Group A or Group B).

  • Group A: participants receive the study medicine (PF-07220060) in combination with fulvestrant.
  • Group B: participants receive either fulvestrant alone or everolimus in combination with exemestane. The decision of which treatment option is best suited for each Group B participant will be made by the study doctor, who will then inform the participant of the chosen treatment. 

All participants will receive active medicine. There is no placebo in FourLight-1.

 You will continue to receive study treatment until imaging scans (such as an MRI and/or CT) show that your cancer is getting worse, the study doctor thinks you are no longer benefitting from the study treatment you are receiving in the clinical trial, you have side effects that become too severe, or you choose to stop taking part.

Length of study treatment

Depends on how you tolerate the treatment, how your cancer responds, and your personal choice

Number of study visits

About 1-2 visits per month

Long-term follow up

The study team will continue to monitor your health and disease status over time until the study is complete, which may last several years, or until you withdraw your consent to be contacted

About the study medicine (PF-07220060)

Watch a short video to learn more about FourLight-1 and the study medicine (PF-07220060).

 

Be represented

Where and how we live, work, and play and other biological factors controlled by our genetics can impact our health, risk for disease, and how we may respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. In the US, tumor characteristics (biology) and health outcomes of people affected by advanced or metastatic breast cancer vary greatly by race, ethnicity, age, and socioeconomic differences. 

Advanced and metastatic breast cancer diagnoses among Asian women under age 50 in the US have increased annually since 2018. And although non-Hispanic White women are more likely to be diagnosed with HR-positive, HER2-negative breast cancer, African American and Black women die at higher rates from metastatic breast cancer. 

Our aim is to help reflect the diversity of people to improve the development of novel study medicines, learn how they work for different people, and reduce health disparities among underrepresented populations.

Be represented

Portrait of women eating lunch– Pfizer Clinical Trials
Portrait of women eating lunch– Pfizer Clinical Trials

Frequently asked questions

Where can I find more information about this clinical trial?

Additional details will be provided during the informed consent process.

Is this helpful?
Will I receive active medicine?

Yes. All participants will receive active medicine. There is no placebo in this clinical trial. You will have a 50% chance of receiving the study medicine (PF-07220060) in combination with fulvestrant and a 50% chance of receiving the study doctor’s choice of either fulvestrant alone or everolimus in combination with exemestane.

Is this helpful?
What are the treatments in this clinical trial and how are they given?

The study medicine (PF-07220060)

The study medicine (PF-07220060) is a tablet that is taken by mouth. The tablets should be swallowed whole and taken twice a day, with food, at about the same time every day.

Fulvestrant

Fulvestrant is given as an injection. Fulvestrant will be administered into the buttocks muscle by a healthcare professional during study office visits.

Everolimus and exemestane

Everolimus and exemestane are given as tablets that are taken by mouth once per day. The tablets should be swallowed whole and should be taken at about the same time every day. 

Is this helpful?
How long will I receive treatment in FourLight-1?

You will continue to receive study treatment until imaging scans (such as an MRI and/or CT) show that your cancer is getting worse, the study doctor thinks you are no longer benefitting from the study treatment you are receiving in the clinical trial, you have side effects that become too severe, or you choose to stop taking part.

Is this helpful?
How long do the study visits last?

Study visits will last a few hours. Your study doctor will let you know exactly how long you will need to stay for each visit.

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Do I have to go to the study visits in person? Are tele-health visits an option on this clinical trial?

You will need to attend most study visits in person. This is because the type of evaluations that are part of this clinical trial need to be done in person. If you can’t make a scheduled visit, you should contact the study team as soon as possible to reschedule. Some visits in the follow-up period (once you stop receiving the clinical trial treatment) may be conducted via telephone.

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What happens after I stop receiving treatment in FourLight-1?

If for any reason you are asked to stop the study treatment or you want to stop the study treatment, end of treatment procedures will be performed as soon as possible after your last dose of study treatment. Then you will continue with the follow-up period of the study. During the follow-up period the study team will continue to monitor your health and disease status over time until the study is complete, which may last several years, or until you withdraw your consent to be contacted.

Is this helpful?
Is my participation voluntary?

You are always free to leave a clinical trial at any time and for any reason, without penalty to you. If you decide to leave the clinical trial, please tell the study doctor so that you can end participation in the safest way. The study doctor will explain what other steps may occur. 

 Your decision to stop being in the clinical trial will not affect your regular medical care or any benefits to which you are entitled.

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Will my information be kept private and confidential?

Your privacy and confidentiality are our priority while participating in our clinical trials. Your personal information will be protected in compliance with relevant laws, and in the manner explained in the informed consent document.

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Contact us

To talk with a Nurse Navigator about Pfizer’s breast cancer clinical trials, call the Pfizer clinical trial contact center 1-844-877-2345.

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