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

Primary Purpose

Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative, Stage IA Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fulvestrant

Laboratory Biomarker Analysis

Palbociclib

Questionnaire Administration

Aromatase Inhibitors

About this trial

This is an interventional treatment trial for Estrogen Receptor and/or Progesterone Receptor Positive

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

St. Elizabeth HealthcareRecruiting
Case Western UniversityRecruiting
Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (fulvestrant, palbociclib)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Change in cognition, as measured by Blessed Orientation-Memory-Concentration Test

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

Change in depression, as measured by the Geriatric Depression Scale

Change in functional status, as measured by the Karnofsky Performance Status Physician-Reported Scale

Change in functional status, as measured by the History of falls

Change in functional status, as measured by the Timed Up test

Change in functional status, as measured by the Go Test

Change in functional status, as measured by the Instrumental Activities of Daily Living

Change in nutritional status, as measured by the Mini Nutritional Assessment

Change in social activity and support, as measured by the Medical Outcome Study (MOS)

Change in social activity and support, as measured by Social Activity Limitations Survey.

Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4

The proportion of adverse events and the exact binomial confidence interval for the rates will also be calculated.

Progression free survival

Calculated using Kaplan-Meier methods.

Progression free survival (PFS)

Calculated using Kaplan-Meier methods

Full Information

NCT ID

NCT02760030

First Posted

March 29, 2016

Last Updated

May 3, 2023

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02760030

Brief Title

Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 16, 2017 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (fulvestrant, palbociclib)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Fulvestrant

Other Intervention Name(s)

Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780, ZD9238

Intervention Description

Given IM

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Intervention Type

Drug

Intervention Name(s)

Palbociclib

Other Intervention Name(s)

Ibrance, PD-0332991, PD-332991

Intervention Description

Given PO

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Correlative studies

Intervention Type

Drug

Intervention Name(s)

Aromatase Inhibitors

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

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

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.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Change in cognition, as measured by Blessed Orientation-Memory-Concentration Test

Description

Time Frame