NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Although there have been significant advancements in breast cancer therapy, there’s still a need to develop treatment options with fewer side effects that result in a better quality of life for people living with breast cancer.
The goal of the FourLight-3 clinical trial is to help us learn which study treatment combinations may work better to slow down the growth of cancer cells, shrink tumors, and prolong the time without the disease getting worse with fewer side effects.
This clinical trial might be an option if you have been diagnosed with HR-positive, HER2-negative locally advanced or metastatic breast cancer and have not received any prior systemic cancer therapy* for your locally advanced or metastatic disease.
*Systemic cancer therapy is any type of treatment that targets cancer cells throughout the whole body, like chemotherapy, hormone therapy, and immunotherapy.
Other criteria may apply, which the study team will discuss with you.
Condition
HR-positive, HER2-negative locally advanced or metastatic breast cancer
Age
18+ years
Sex
Male or Female
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 study.
If you choose to participate, you will sign a consent document and continue with the screening period. During the screening period, tests (such as a physical exam, tumor imaging, and blood sample collections) will be performed to confirm whether you meet all eligibility criteria.
If you qualify for FourLight-3 and choose to participate, you will be randomly assigned to received one of the two following combinations:
*Letrozole is an approved medication commonly used worldwide for the treatment of breast cancer
You will continue to receive study treatment until imaging scans show that your cancer is getting worse, the study doctor thinks you are no longer benefitting from the study treatment, you have side effects that become too severe, or you choose to stop taking part.
Your health and tumor growth will be regularly monitored by an experienced team of healthcare providers throughout the study.
Length of study treatment
Depends on how your cancer responds, how well you tolerate the study treatments, and your personal choice
Number of study visits
About 2x per month, for the first 2 months, then about every 4-weeks
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
The study medicine PF-07220060 is a CDK/4 inhibitor based-therapy thought to work by blocking specific growth signals within breast cancer cells, preventing the cells from growing. The study medicine, when combined with letrozole, may work as a “brake” to slow down the growth of cancer cells.
Many factors, including genetics, race, and ethnicity, can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
When you participate in a clinical trial, you’re paving the way for both the community you represent, and all people affected by breast cancer.
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) plus letrozole and a 50% chance of receiving the study doctor’s choice of treatment plus letrozole. No one (including you, your personal doctor, or the study team) can choose the group you will be in.
One group will have the study medicine PF-07220060 in combination with letrozole (approved for the treatment of breast cancer)
You will continue to receive study treatment until imaging scans show that your cancer is getting worse, the study doctor thinks you are no longer benefiting from the study treatment, you have side effects that become too severe, or you choose to stop taking part in the study.
Most visits may be up to 1 hour, while a couple may be 2-3 hours, depending on required assessments. Your study doctor will let you know exactly how long you will need to stay for each visit.
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.
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.
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.
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.
