EUCTR2011-000621-80-FR进行中（未招募）1 期
Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 297
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Woman >=18 years of age and postmenopausal determined by one of the following:
- •bilateral, surgical oophorectomy
- •age >=60 years
- •age <60 years, with amenorrhea >=24 months and follicle-stimulating hormone and luteinizing hormone concentrations within postmenopausal range
- •2. ER+, Her2 - metastatic breast cancer, confirmed within 7 days before randomization with FFPE tissue from either primary or metastatic breast cancer site, that recurred during or within 6 months of discontinuing anastrozole or letrozole therapy in adjuvant or metastatic setting; subjects with disease confined only to bone may be included.
- •3. Disease must have been sensitive to anastrozole or letrozole therapy prior to disease progression. Sensitivity to anastrozole or letrozole is defined as either stable disease or better for >=6 months in the metastatic setting or relapse free for >=2 years in the adjuvant setting.
- •4. No more than two prior lines of therapy in the metastatic setting, of which no more than one was chemotherapy [Note: Simultaneous combination treatment is considered one line of therapy.]
- •5. Eastern Cooperative Oncology Group (ECOG) performance status score of <=1
- •6. Clinical laboratory values during Screening:
- •hemoglobin >=10.0 g/dL
- •neutrophils >=1.5 x 10^9/L
- •platelets >=100 x 10^9/L
- •total bilirubin <=1.5 x upper limit of normal (ULN)
- •alanine (ALT) and aspartate (AST) aminotransferase <=2.5xULN
- •alkaline phosphatase <=6xULN unless bone metastases with no liver disorder
- •serum creatinine <1.5xULN or creatinine clearance >=50 mL/min
- •serum potassium >=3.5 mM
- •serum albumin >=3.0 g/dL
- •prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits [Exception: PT and international normalized ratio (INR) will be abnormally prolonged in subjects taking warfarin.]
- •7. Systolic blood pressure <160 mm Hg and diastolic blood pressure <95 mm Hg [Note: Hypertension controlled by antihypertensive therapy is permitted].
- •8. Cardiac ejection fraction >=50% measured by MUGA or ECHO done within 4 weeks before randomization
- •9. If receiving a bisphosphonate or denosumab, dose must have been stable for at least 2 doses before randomization.
- •10. Willing and able to adhere to prohibitions and restrictions specified in this protocol
- •11. 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
- •12. Signs the informed consent document within 4 weeks before randomization for pharmacogenomics research indicating willingness to participate in the pharmacogenomic component of the study, where local regulations permit. [Note: Refusal to give consent for this component does not exclude a subject from participation in this clinical study.]
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor
- •2. Anticancer immunotherapy or investigational agent within 4 weeks before randomization, or anticancer radiotherapy (except palliative) or anticancer endocrine therapy within 2 weeks before randomization [Note: Potential subjects must not have taken anastrozole, letrozole, fulvestrant, or any chemotherapy for at least 2 weeks (bevacizumab for at least 3 weeks) before study entry.]
- •3. Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection
- •4. Clinical or biochemical evidence of hyperaldosteronism or hypopituitarism
- •5. 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
- •6. Major thoracic or abdominal surgery or significant traumatic injury with 4 weeks before randomization or plans surgery during study participation or within 4 weeks after the last dose of study drug [Note: Patients with planned surgical procedures to be conducted under local anesthesia are not excluded from the study.]
- •7. Persistent >=Grade 2 toxicity from any cause [Note: Chemotherapy-induced alopecia and Grade 2 peripheral neuropathy are allowed.]
- •8. Symptomatic central nervous system disease or leptomeningeal disease
- •9. Gastrointestinal disorder interfering with study drug absorption
- •10. Active or uncontrolled autoimmune disease that may require corticosteroid therapy
- •11. Active or symptomatic viral hepatitis or chronic liver disease
- •12. 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
- •13. Known allergies, hypersensitivity, or intolerance to abiraterone acetate, exemestane, prednisone, or their excipients
- •14. Contraindications to the use of exemestane or prednisone per local prescribing information
- •15. 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
研究者
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