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

The Ohio State University

Status and phase: Enrolling; Phase 2

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; HER2/Neu Negative; Estrogen Receptor and/or Progesterone Receptor Positive; Stage IIB Breast Cancer; Stage IIA Breast Cancer; Stage IIIC Breast Cancer; Stage IA Breast Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02760030

OSU-15266

NCI-2016-00146 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Treatment (fulvestrant, palbociclib)

Experimental group

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.

Treatment:

Drug: Aromatase Inhibitors

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Drug: Fulvestrant

Drug: Palbociclib