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

NCT02760030 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-15266NCI-2016-00146
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (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

  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.

  1 year

Secondary Outcomes (14)

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

  Baseline to up to 12 weeks after removal from study

• Change in comorbidities, as measured by the Charlson comorbidity index

  Baseline to up to 12 weeks after removal from study

• Change in depression, as measured by the Geriatric Depression Scale

  Baseline to up to 12 weeks after removal from study

• Change in functional status, as measured by the ECOG Performance Status Scale

  Baseline to up to 12 weeks after removal from study

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

  Baseline to up to 12 weeks after removal from study

Study Arms (1)

Treatment (fulvestrant, palbociclib)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis; Drug: Palbociclib; Other: Questionnaire Administration; Drug: Aromatase Inhibitors

Interventions

Fulvestrant DRUG

Given IM

Also known as: Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780, ZD9238

Treatment (fulvestrant, palbociclib)

Palbociclib DRUG

Given PO

Also known as: Ibrance, PD-0332991, PD-332991

Treatment (fulvestrant, palbociclib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (fulvestrant, palbociclib)

Questionnaire Administration OTHER

Correlative studies

Treatment (fulvestrant, palbociclib)

Aromatase Inhibitors DRUG

Given PO

Treatment (fulvestrant, palbociclib)

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (3)

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Case Western University

Cleveland, Ohio, 44106, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; palbociclib; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Nicole O Williams, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: May 3, 2016
• Study Start: February 16, 2017
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)