NCT01814865撤回2 期
Pre-operative Assessment of the Anti-Proliferative Effects and Genomic Alterations of 2 Weeks of Abiraterone Acetate Compared to 2 Weeks of an Aromatase Inhibitor in Post-menopausal Hormone Receptor Positive Operable Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Differences in genomic expression and biological activity
研究概览
简要总结
This study is being offered to patients who are post-menopausal, have breast cancer with a positive estrogen and/or progesterone hormone receptor test and are currently awaiting surgery for breast cancer.
The purpose of this study is to determine whether abiraterone acetate has different hormonal and genomic effects than non-steroidal aromatase inhibitors in the treatment of post-menopausal hormonal receptor positive primary operable breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman greater than or equal to 18 years of age and postmenopausal determined by one of the following:
- •bilateral surgical oophorectomy
- •age greater than or equal 60 years
- •age <60 years, with amenorrhea greater than or equal 24 months and follicle-stimulating hormone and luteinizing hormone concentrations within postmenopausal range
- •Subjects with ER+ (Allred 3-8), HER2 - primary operable T1-T3 breast cancer with a primary tumor size of ≥ 1.5 cm on physical examination or imaging studies
- •Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 1
- •Criterion modified per amendment 7.1 Clinical laboratory values during Screening:
- •hemoglobin greater than or equal 10.0 g/dL
- •neutrophils greater than or equal 1.5 x 109/L
- •platelets greater than or equal100 x 109/L
- •total bilirubin less than or equal to 1.5x upper limit of normal (ULN) - except for a known diagnosis of Gilbert's syndrome
- •alanine (ALT) and aspartate (AST) aminotransferase less than or equal to 1.5xULN
- •alkaline phosphatase less than or equal to 1.5xULN
- •serum creatinine <1.5xULN or creatinine clearance greater than or equal 45 mL/min
- •serum potassium greater than or equal 3.5 mM
- •serum albumin greater than or equal 3.0 g/dL
- •INR (or PT) and partial thromboplastin time (PTT) within normal limits
- •Systolic blood pressure <180 mm Hg and diastolic blood pressure <100 mm Hg [Note: Hypertension controlled by antihypertensive therapy is permitted].
- •Willing and able to adhere to prohibitions and restrictions specified in this protocol
- •Signs an informed consent document within 4 weeks before randomization indicating she understands the purpose of and procedures required for the study and is willing to participate in the study
排除标准
- •Prior treatment with ketoconazole, aminoglutethimide or a CYP17 inhibitor. [Note: Prior treatment with ketoconazole for ≤7 days is permitted and topical formulations of ketoconazole are permitted]
- •Anticancer immunotherapy, investigational agent, anticancer radiotherapy or anticancer endocrine therapy within 12 weeks before randomization
- •Use of hormone replacement therapy within the past 4 weeks
- •Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection
- •Clinical or biochemical evidence of hyper-aldosteronism or hypopituitarism
- •Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments
- •Major thoracic or abdominal surgery or significant traumatic injury with 4 weeks before randomization [Note: Patients with planned surgical procedures to be conducted under local anesthesia are not excluded from the study (e.g. intravascular device insertion)]
- •Gastrointestinal disorder interfering with study drug absorption
- •Positive serology for hepatitis B surface antigen or hepatitis C antibody
- •Active or symptomatic viral hepatitis or chronic liver disease
- •History of clinically significant heart disease, ie, myocardial infarction or arterial thrombotic event within 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease
- •Known allergies, hypersensitivity, or intolerance to abiraterone acetate, prednisone, or their excipients
- •Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the planned first dose of study drug or is currently enrolled in an investigational study
研究组 & 干预措施
Abiraterone Acetate + Prednisone
Experimental
Abiraterone 1000mg PO OD + Prednisone 5mg PO OD x 2 weeks
干预措施: Abiraterone Acetate (Drug)
Abiraterone Acetate + Prednisone
Experimental
Abiraterone 1000mg PO OD + Prednisone 5mg PO OD x 2 weeks
干预措施: Prednisone (Drug)
Aromatase Inhibitor
Active Comparator
Anastrozole 1mg PO OD x 2 weeks
干预措施: Aromatase Inhibitor (Drug)
结局指标
主要结局
Differences in genomic expression and biological activity
时间窗: 2 weeks (baseline and day 14)
To determine the differences in genomic expression changes with 2 weeks of abiraterone acetate plus prednisone relative to changes with 2 weeks of an aromatase inhibitor as a means to assess for potential differences in biological activity between abiraterone acetate and aromatase inhibitors in breast cancer
次要结局
- Change in proliferation(2 weeks (baseline and day 14))
- Resulting adverse events of two weeks of abiraterone acetate(2 weeks (baseline and day 14))
- Changes in plasma hormone levels(2 weeks (baseline and day 14))
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Assessing Treatment Response in Breast Cancer With Functional ImagingBreast CancerNCT02688257Institute of Cancer Research, United Kingdom53
Unknown
3 期
Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast CancerBreast CancerNCT02097459Peking Union Medical College Hospital600
已完成
不适用
A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With ChemotherapyBreast CancerNCT00644683Lynn Henry28
终止
2 期
Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBICancer of BreastNCT02375048Istituto Clinico Humanitas179
尚未招募
不适用
Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World StudyHormone-receptor-positive Breast CancerPremenopausal Breast CancerBreast Cancer Patients at Intermediate to High RiskOvarian Function Suppression Combined With Aromatase Inhibitor or Tamoxifen or TorimefenNCT05801705Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University700