FOURLIGHT-3
Research type
Research Study
Full title
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)
IRAS ID
1011055
Contact name
Alisa Rahilly
Contact email
Sponsor organisation
Pfizer Inc.
ISRCTN Number
Not available
Clinicaltrials.gov Identifier
Research summary
While advancements in treatment, including CDK4/6 inhibitors, have improved outcomes for patients with HR-positive, HER2-negative advanced breast cancer, there is still a need for more effective treatments with fewer side effects (an expected or unexpected reaction to a medicine or treatment). The purpose of this international Pfizer-sponsored study is to learn about the safety and how effective the study medicine (PF-07220060) plus letrozole compared to currently approved CDK4/6 inhibitors in combination with letrozole to treat HR+, HER2- advanced/metastatic breast cancer. The study medicine when combined with hormone therapy is thought to work by slowing down the growth of breast cancer cells with few side effects. This study is seeking female and male participants who: are 18 years of age or older; are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; have advanced or metastatic breast cancer (that has spread beyond the breast to other parts of the body); have not received systemic treatment for advanced or metastatic disease; do not have any medical or mental conditions that may increase the risk of study participation.
Half of the participants will take PF-07220060 with letrozole. The other half will take a currently approved CDK4/6 inhibitor chosen by the investigator with letrozole. All treatment therapies are taken by mouth. Experiences of participants receiving the study medicine plus letrozole will be compared to those who are receiving the CDK4/6 inhibitors plus letrozole. This will help decide if the study medicine combination is more efficacious and tolerable than currently approved treatments.
Participants will be in study treatment until:
- Imaging scans (such as an MRI and/or CT) to monitor tumour growth.
- The study doctor thinks the participant is no longer benefitting from treatment.
- Has side effects that become too severe.
- The participant chooses to stop taking part in this.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0031
Date of REC Opinion
24 Mar 2025
REC opinion
Further Information Favourable Opinion