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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Study participants will be randomly assigned into 1 of 2 groups in parallel for the entire duration of the study. The experimental arm will receive PF-07220060 and letrozole (Arm A) while the comparator arm with receive the study doctors choice of CDK4/6i and letrozole (Arm B).
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth
  • Drug: PF-07220060
    CDK4 inhibitor
  • Drug: letrozole
    endocrine therapy
Active Comparator
Arm B 		Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth
  • Drug: letrozole
    endocrine therapy
  • Drug: abemaciclib
    CDK4/6 inhibitor
  • Drug: palbociclib
    CDK4/6 inhibitor
  • Drug: ribociclib
    CDK4/6 inhibitor

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.