Major Program
Supportive Care and Symptom Management
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
Alliance for Clinical Trials in Oncology
Status
Active, not recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT03633331
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.
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.
Intervention
Palbociclib, Letrozole, Fulvestrant, Questionnaire Administration, Quality-of-Life Assessment
Condition
Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7
Investigators
Mina Sedrak, MD, MS