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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Fulvestrant (Drug)
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.
干预措施: Laboratory Biomarker Analysis (Other)
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.
干预措施: Palbociclib (Drug)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Aromatase Inhibitors (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)
- Change in functional status, as measured by the Timed Up test(Baseline to up to 12 weeks after removal from study)
- Change in functional status, as measured by the Go Test(Baseline to up to 12 weeks after removal from study)
- Change in functional status, as measured by the Instrumental Activities of Daily Living(Baseline to up to 12 weeks after removal from study)
- Change in nutritional status, as measured by the Mini Nutritional Assessment(Baseline to up to 12 weeks after removal from study)
- Change in social activity and support, as measured by the Medical Outcome Study (MOS)(Baseline to up to 12 weeks after removal from study)
- Change in social activity and support, as measured by Social Activity Limitations Survey.(Baseline to up to 12 weeks after removal from study)
- Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4(Up to 12 weeks after removal from study)
- Progression free survival(Up to 1 year)
- Progression free survival (PFS)(Up to 2 years)
研究者
Nicole Williams
Principal Investigator
Ohio State University Comprehensive Cancer Center