PF-07220060 + Letrozole for Breast Cancer (FourLight-3 Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: * HR-positive (breast cancer cells that need estrogen or progesterone to grow) * HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface); * locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body) * who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease. Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Eligibility Criteria

This trial is for adults with HR-positive, HER2-negative breast cancer that's locally advanced or metastatic. They should not have had any prior systemic anti-cancer treatments for their advanced condition.

Inclusion Criteria

My breast cancer is advanced and cannot be removed by surgery or cured with radiation.

My tumor is not HER2 positive.

My tumor is positive for estrogen or progesterone receptors.

I haven't had any drug treatments for my advanced cancer.

Exclusion Criteria

I have or had cancer spread to my brain or spinal cord.

My cancer returned within 12 months after my last CDK4/6 inhibitor treatment.

Participant Groups

The study tests the safety and effectiveness of PF-07220060 combined with letrozole against approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole). Participants are randomly chosen to receive either the new combination or standard treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment2 Interventions

PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth

Group II: Arm BActive Control4 Interventions

Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth