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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nicole Williams, Ohio State University Comprehensive Cancer Center

Brief Summary:
This phase II clinical trial studies how well fulvestrant and palbociclib works in treating older patients with breast cancer that responds to hormone treatment (hormone responsive) that cannot be removed by surgery. Estrogen can cause the growth of estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for hormone responsive breast cancer.

Condition or disease Intervention/treatment Phase
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

Detailed 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-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.


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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Fulvestrant
Given IM
Other Names:
  • Faslodex
  • Faslodex(ICI 182,780)
  • ICI 182,780
  • ICI 182780
  • ZD9238

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Palbociclib
Given PO
Other Names:
  • Ibrance
  • PD-0332991
  • PD-332991

Other: Questionnaire Administration
Correlative studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Progression free survival [ Time Frame: Up to 1 year ]
    Calculated using Kaplan-Meier methods.

  14. Progression free survival (PFS) [ Time Frame: Up to 2 years ]
    Calculated using Kaplan-Meier methods



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu

Locations
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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         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nicole Williams, MD Ohio State University Comprehensive Cancer Center

Additional Information:
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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
Additional relevant MeSH terms:
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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