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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

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06760637
Protocol IDs
C4391024 (primary)
NCI-2025-01126
2024-512925-95-00
Study Sponsor
Pfizer Inc

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.

Eligibility

  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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.