Fulvestrant and Palbociclib in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
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ClinicalTrials.gov Identifier: NCT02760030 |
Recruitment Status :
Recruiting
First Posted : May 3, 2016
Last Update Posted : September 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: Fulvestrant Other: Laboratory Biomarker Analysis Drug: Palbociclib Other: Questionnaire Administration | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 37 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor Or Operable Tumor But Cannot Undergo Surgery Due to Frailty Or Who Refuse Surgery |
Study Start Date : | May 2016 |
Estimated Primary Completion Date : | July 2020 |

Arm | Intervention/treatment |
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Experimental: 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.
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Drug: Fulvestrant
Given IM
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Palbociclib Given PO
Other Names:
Other: Questionnaire Administration Correlative studies |
- Treatment failure-free survival (TFFS) defined as the proportion of study subjects who remain on treatment from the 1st day of therapy to one year [ Time Frame: 1 year ]The proportion of subjects who do not experience treatment failure at one year will be calculated along with the exact binomial confidence interval for the rate.
- Change in cognition, as measured by Blessed Orientation-Memory-Concentration Test [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in comorbidities, as measured by the Charlson comorbidity index [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in depression, as measured by the Geriatric Depression Scale [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in functional status, as measured by the Karnofsky Performance Status Physician-Reported Scale [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in functional status, as measured by the History of falls [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in functional status, as measured by the Timed Up test [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in functional status, as measured by the Go Test [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in functional status, as measured by the Instrumental Activities of Daily Living [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in nutritional status, as measured by the Mini Nutritional Assessment [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in social activity and support, as measured by the Medical Outcome Study (MOS) [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Change in social activity and support, as measured by Social Activity Limitations Survey. [ Time Frame: Baseline to up to 12 weeks after removal from study ]Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
- Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 12 weeks after removal from study ]The proportion of adverse events and the exact binomial confidence interval for the rates will also be calculated.
- Progression free survival [ Time Frame: Up to 1 year ]Calculated using Kaplan-Meier methods.
- Progression free survival (PFS) [ Time Frame: Up to 2 years ]Calculated using Kaplan-Meier methods

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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newly diagnosed invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER2 negative breast cancer; ER-and/or PR-positive breast cancer is defined by > 10% staining by immunohistochemistry
- 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:
- Prior aromatase inhibitor therapy
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760030
Contact: Ohio State University Comprehensive Cancer Center | 1-800-293-5066 | Jamesline@osumc.edu |
United States, Ohio | |
Ohio State University Comprehensive Cancer Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Megan Laibach Thomason 614-366-0115 Megan.Laibachthompson@osumc.edu | |
Principal Investigator: Nicole Williams |
Principal Investigator: | Nicole Williams, MD | Ohio State University Comprehensive Cancer Center |
Additional Information:
Responsible Party: | Nicole Williams, Principal Investigator, Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT02760030 History of Changes |
Other Study ID Numbers: |
OSU-15266 NCI-2016-00146 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) P30CA016058 ( U.S. NIH Grant/Contract ) |
First Posted: | May 3, 2016 Key Record Dates |
Last Update Posted: | September 23, 2016 |
Last Verified: | September 2016 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Palbociclib Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |