Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

Summary

This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

Timeline

Start

2018-08-15

Primary completion

2020-09-08

Completion

2026-02-27

Publications

• Sedrak MS, Lee MK, Ji J, Satele DV, Freedman RA, Poorvu PD, O'Connor T, Williams GR, Hopkins JO, Muss HB, Cohen HJ, Partridge AH, Carey LA, Chow SL, Subbiah N, Le-Rademacher J, Jatoi A. Palbociclib in adults aged 70 years and older with advanced breast cancer: A phase 2 multicenter trial (Alliance A171601). J Geriatr Oncol. 2024 Jul;15(6):101813. doi: 10.1016/j.jgo.2024.101813. Epub 2024 Jun 8.

Drugs

Indications