Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
NCT ID: NCT02760030
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2017-02-16
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (fulvestrant, palbociclib)
Patients receive fulvestrant IM on days 1 and 15. Patients also receive palbociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Fulvestrant
Given IM
Laboratory Biomarker Analysis
Correlative studies
Palbociclib
Given PO
Questionnaire Administration
Correlative studies
Aromatase Inhibitors
Given PO
Interventions
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Fulvestrant
Given IM
Laboratory Biomarker Analysis
Correlative studies
Palbociclib
Given PO
Questionnaire Administration
Correlative studies
Aromatase Inhibitors
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be vulnerable or frail by Balducci Criteria or the patient is refusing breast surgery; vulnerable patients are defined as those with dependence in some instrumental activities of daily living, well controlled co-morbidities, and early symptoms of geriatric syndrome; frail patients are defined as those with three or more co-morbidities, dependence in one or more activities of daily living, or a clinically significant geriatric syndrome; geriatric syndromes include: dementia, delirium, incontinence (fecal and/or urinary), osteoporosis or spontaneous fractures, polypharmacy, visual/hearing impairment, sarcopenia and neglect or abuse
* The patient's refusal to proceed with curative breast surgery has to be documented by the surgeon's and medical oncologist's note
* Absolute neutrophil count (ANC) \> 1000/uL
* Platelets \> 75,000/L
* Serum creatinine 1.5 X institutional upper limit of normal (ULN)
* Total bilirubin \< 1.5 X ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 2.5 ULN
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Evidence of distant metastases
* Psychiatric illness, which would prevent the patient from giving informed consent
* Patients receiving strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)
65 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Nicole Williams
Principal Investigator
Principal Investigators
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Nicole O Williams, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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St. Elizabeth Healthcare
Edgewood, Kentucky, United States
Case Western University
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2016-00146
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-15266
Identifier Type: -
Identifier Source: org_study_id