CTRI/2017/03/008034已完成3 期
A Study of Palbociclib in Combination With Letrozole as Treatment of Post-Menopausal Women With Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer for Whom Letrozole Therapy is Deemed Appropriate
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patient eligibility should be reviewed and documented by an appropriate member of the investigatorâ??s study team before patients are included in the study.
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Women of >=18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease).
- •2. Post-menopausal status defined as per local practice
- •3. ER(+) and/or PgR(+) tumor based on local laboratory results (test as per local practice)
- •4. HER2(-) breast cancer based on local laboratory results (test as per local practice or local guidelines)
- •5. Patients must be appropriate candidates for letrozole therapy. (in the first-line advanced/metastatic disease setting).
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •7. Adequate bone marrow function:
- •Absolute Neutrophil Count (ANC) >=1,500/mm3 (1.5 x 109 /L);
- •Platelets >=100,000/mm3 (100 x 109 /L);
- •Hemoglobin >=9 g/dL (90 g/L).
- •8. Adequate liver function:
- •Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) <=3 x Upper Limit of Normal (ULN) (<=5.0 x ULN if liver metastases present);
- •Alkaline phosphatase <=2.5 x ULN (<=5.0 x ULN if bone or liver metastases present);
- •Total serum bilirubin <=1.5 x ULN (<=3.0 x ULN if Gilbertâ??s disease).
- •9. Adequate renal function:
- •Serum creatinine <=1.5 x ULN or estimated creatinine clearance >= 60 mL/min
- •10. Resolution of all acute toxic effects of prior therapy, including radiotherapy to grade <=1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.
- •11. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •12. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Patients presenting with any of the following will not be included in the study:
- •1. Known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib excipients.
- •2. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 isoenzymes within 7 days prior to study entry
- •3. Prior treatment with any CDK inhibitor.
- •4. Previous participation in a palbociclib trial.
- •5. Participation in other studies involving investigational drug(s) (Phases 1-4) within 2 weeks before the current study begins and/or during study participation.
- •6. QTc >480 msec (based on the mean value from triplicate electrocardiograms [ECGs]; see Appendix 2 of Protocol Amendment 3 dated 31 May 2016 for suggested QTc calculation); history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
- •7. High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months of enrollment.
- •8. Diagnosis of any second malignancy within the last 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- •9. Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigatorâ??s judgment, brain metastases are permitted.
- •10. Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •11. Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study.
研究者
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