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

Phase 3RecruitingNCT06760637

Pfizer1,020 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,020

Conditions

Breast Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Progression Free Survival (PFS) by BICR

Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first

Time frame: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)

Secondary Outcomes

Overall Survival (OS)

Time from the date of randomization to the date of death due to any cause

Time frame: From the date of randomization until death due to any cause (up to approximately 13 years).

Progression Free Survival (PFS) by Investigator

Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first

Time frame: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)

OR by BICR and by investigator

Time from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first

Time frame: From randomization to progression or death whichever occurs first (up to approximately 4 years)

Duration of Response (DoR) by BICR and by investigator

Time from the date of CR or PR to the first documentation of objective progressive disease, or death due to any cause, whichever occurs first

Time frame: From the date of CR or PR until objective progressive disease, or death (up to approximately 4 years)

Incidence of treatment emergent treatment related adverse events (AE)

Incidence and severity of AEs graded according to the NCI CTCAE v5.0

Time frame: Duration of the study approximately up to 13 years.

Incidence of treatment emergent treatment related serious adverse events

Incidence and severity of AEs graded according to NCI CTCAE v5.0

Time frame: Duration of the study approximately up to 13 years.

Estimated mean change from baseline in EORTC QLQ C30