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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-07220060 — DRUG
  CDK4 inhibitor
• letrozole — DRUG
  endocrine therapy
• abemaciclib — DRUG
  CDK4/6 inhibitor
• palbociclib — DRUG
  CDK4/6 inhibitor
• ribociclib — DRUG
  CDK4/6 inhibitor

Study Details

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.

Key Dates

Start date

Jan 6, 2025

Status verified

May 2026

Primary completion

Jan 2, 2029

Completion

Dec 29, 2037

Study Design

Enrollment

1,035 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth
• Active Comparator: Arm B
  Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth

Primary Outcome Measure

Progression Free Survival (PFS) by BICR [ Time Frame: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years) ]

Locations (218)

Find similar trials in Birmingham, AL

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