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

a study on Breast Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends around

Description

Summary

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)

Keywords

Breast Cancer, 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, 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, Breast Neoplasms, Recurrence, Unilateral Breast Neoplasms, Letrozole

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • San Vicente Surgical Center accepting new patients
    Los Angeles 5368361 California 5332921 90025 United States
  • Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location) accepting new patients
    Beverly Hills 5328041 California 5332921 90211 United States
  • Cedars-Sinai Cancer Beverly Hills accepting new patients
    Beverly Hills 5328041 California 5332921 90211 United States
  • Cedars-Sinai Cancer at Cedars-Sinai Medical Center (drug treatment and dispensing location) accepting new patients
    Los Angeles 5368361 California 5332921 90048 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles 5368361 California 5332921 90048 United States
  • Breast Health Services Building accepting new patients
    West Hollywood 5408076 California 5332921 90048 United States
  • Keck Hospital of USC accepting new patients
    Los Angeles 5368361 California 5332921 90033 United States
  • Los Angeles General Medical Center accepting new patients
    Los Angeles 5368361 California 5332921 90033 United States
  • Norris Healthcare Center 3 (HC3) accepting new patients
    Los Angeles 5368361 California 5332921 90033 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles 5368361 California 5332921 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
Sign up for this study
ID
NCT06760637
Phase
Phase 3 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 1020 study participants
Last Updated
Contact us about this trial