Clinical Trials /

Fulvestrant or Aromatase Inhibitor and Palbociclib in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery

NCT02760030

Description:

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.

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02760030

Trial Eligibility

Document

Title

  • Brief Title: Fulvestrant or Aromatase Inhibitor and Palbociclib in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
  • Official Title: Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant or an Aromatase Inhibitor 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

Clinical Trial IDs

  • ORG STUDY ID: OSU-15266
  • SECONDARY ID: NCI-2016-00146
  • SECONDARY ID: P30CA016058
  • NCT ID: NCT02760030

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

Interventions

DrugSynonymsArms
FulvestrantFaslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780, ZD9238Treatment (fulvestrant, palbociclib)
PalbociclibIbrance, PD-0332991, PD-332991Treatment (fulvestrant, palbociclib)
Aromatase InhibitorsTreatment (fulvestrant, palbociclib)

Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment (fulvestrant, palbociclib)ExperimentalPatients 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
  • Palbociclib
  • Aromatase Inhibitors

Eligibility 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)
Maximum Eligible Age:N/A
Minimum Eligible Age:70 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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

Measure:Change in cognition, as measured by Blessed Orientation-Memory-Concentration Test
Time Frame:Baseline to up to 12 weeks after removal from study
Safety Issue:
Description: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.
Measure:Change in comorbidities, as measured by the Charlson comorbidity index
Time Frame:Baseline to up to 12 weeks after removal from study
Safety Issue:
Description: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.
Measure:Change in depression, as measured by the Geriatric Depression Scale
Time Frame:Baseline to up to 12 weeks after removal from study
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure:Change in functional status, as measured by the History of falls
Time Frame:Baseline to up to 12 weeks after removal from study
Safety Issue:
Description: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.
Measure:Change in functional status, as measured by the Timed Up test
Time Frame:Baseline to up to 12 weeks after removal from study
Safety Issue:
Description: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.
Measure:Change in functional status, as measured by the Go Test
Time Frame:Baseline to up to 12 weeks after removal from study
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure:Change in nutritional status, as measured by the Mini Nutritional Assessment
Time Frame:Baseline to up to 12 weeks after removal from study
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description:The proportion of adverse events and the exact binomial confidence interval for the rates will also be calculated.
Measure:Progression free survival
Time Frame:Up to 1 year
Safety Issue:
Description:Calculated using Kaplan-Meier methods.
Measure:Progression free survival (PFS)
Time Frame:Up to 2 years
Safety Issue:
Description:Calculated using Kaplan-Meier methods

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ohio State University Comprehensive Cancer Center

Last Updated

December 20, 2019