RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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)

Quick Facts

Study Start:2025-01-06
Study Completion:2037-12-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06760637

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
  3. * Documented HER2-negative tumor
  4. * Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
  5. * Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1
  1. * In visceral crisis at risk of immediately life-threatening complications in the short term.
  2. * Current or past history of central nervous system metastases.
  3. * Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
  4. * Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
  5. * Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Summit Cancer Care, PC
Savannah, Georgia, 31405
United States
Ascension Illinois - Evanston Infusion Center
Evanston, Illinois, 60202
United States
Ascension Illinois-Skokie Infusion Center
Skokie, Illinois, 60077
United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
United States
Mercy Medical Center - Baltimore
Baltimore, Maryland, 21202
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-06
Study Completion Date2037-12-26

Study Record Updates

Study Start Date2025-01-06
Study Completion Date2037-12-26

Terms related to this study

Keywords Provided by Researchers

  • Locally advanced or metastatic breast cancer
  • Estrogen receptor positive [ER(+)]
  • Progesterone receptor positive [PR(+)]
  • Hormone receptor positive [HR(+)]
  • Human epidermal growth factor receptor 2 negative [HER2(-)]
  • ER(+)/HER2(-)
  • PR(+)/HER2(-)
  • HR(+)/HER2(-)
  • Advanced Breast Cancer
  • Breast tumor
  • Breast cancer
  • Palbociclib
  • Abemaciclib
  • Ribociclib
  • Partial Response+ (PR+)
  • Metastatic breast cancer
  • Hormone Therapy
  • Hormone positive breast cancer
  • Recurrent breast cancer
  • HR+
  • HER2-negative
  • Relapse
  • Recurrent
  • First line treatment
  • Left Sided Breast Cancer
  • Left-Sided Breast Cancer
  • Right Sided Breast Cancer
  • Right-Sided Breast Cancer
  • Unilateral Breast Cancer
  • Cancer of the breast
  • CDK4i
  • CDK4/6i
  • Bilateral Breast Cancer

Additional Relevant MeSH Terms

  • Breast Cancer