Fulvestrant or Aromatase Inhibitor and Palbociclib in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Estrogen Receptor and/or Progesterone Receptor Positive
- HER2/Neu Negative
- Stage IA Breast Cancer
- Stage IB Breast Cancer
- Stage IIA Breast Cancer
- Stage IIB Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 70 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine treatment failure-free survival (TFFS) rate at one year of combination therapy with pure estrogen antagonist, fulvestrant and cyclin-dependent kinase (CDK) inhibitor, palbociclib as primary endocrine therapy in patients 70 years or older with newly diagnosed non-m...
PRIMARY OBJECTIVES: I. To determine treatment failure-free survival (TFFS) rate at one year of combination therapy with pure estrogen antagonist, fulvestrant and cyclin-dependent kinase (CDK) inhibitor, palbociclib as primary endocrine therapy in patients 70 years or older with newly diagnosed non-metastatic hormone receptor positive, human epidermal growth factor receptor 2 (HER-2) negative breast cancer. SECONDARY OBJECTIVES: I. To determine 1- and 2-year progression free survival. II. To determine safety and toxicity of this combination in the population of patients 70 years or older. III. To determine whether longitudinal changes in geriatric assessment measures correlate with tolerability of this regimen. OUTLINE: Patients receive fulvestrant intramuscularly (IM) on days 1 and 15. Patients also receive palbociclib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 12 weeks.
Tracking Information
- NCT #
- NCT02760030
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Nicole Williams, MD Ohio State University Comprehensive Cancer Center
Get Well Soon