Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

Description

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.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

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.

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)

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Savannah

Summit Cancer Care, PC, Savannah, Georgia, United States, 31405

Evanston

Ascension Illinois - Evanston Infusion Center, Evanston, Illinois, United States, 60202

Skokie

Ascension Illinois-Skokie Infusion Center, Skokie, Illinois, United States, 60077

Skokie

Orchard Healthcare Research Inc., Skokie, Illinois, United States, 60077

Baltimore

Mercy Medical Center - Baltimore, Baltimore, Maryland, United States, 21202

Bozeman

Bozeman Health Deaconess Hospital, Bozeman, Montana, United States, 59715

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
  • * Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
  • * Documented HER2-negative tumor
  • * Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
  • * Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1
  • * In visceral crisis at risk of immediately life-threatening complications in the short term.
  • * Current or past history of central nervous system metastases.
  • * Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
  • * Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
  • * Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2037-12-26