CTRI/2017/03/008034已完成Phase 3 4
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
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 12
- 主要终点
- Percentage of patients with treatment-emergent adverse events (AEs) or serious adverse events (SAEs)
研究概览
简要总结
This is an open-label, single arm, multinational, multicenter clinical trial. Post-menopausal women with HR-Positive and HER2-Negative Advanced Breast Cancer will be enrolled. Patients will have histologically or cytologically proven diagnosis of adenocarcinoma of the breast (locoregionally recurrent or metastatic disease) and will be candidates to receive letrozole as their best therapeutic option. Patients will continue to receive treatment with palbociclib and letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. Patients who permanently discontinue palbociclib or letrozole for any reason will be off study. Approximately 100 patients will be enrolled in this study from India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient eligibility should be reviewed and documented by an appropriate member of the investigator’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:
- •Women of ≥18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease).
- •Post-menopausal status defined as per local practice
- •ER(+) and/or PgR(+) tumor based on local laboratory results (test as per local practice)
- •HER2(-) breast cancer based on local laboratory results (test as per local practice or local guidelines)
- •Patients must be appropriate candidates for letrozole therapy.
- •(in the first-line advanced/metastatic disease setting).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •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).
- •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 Gilbert’s disease).
- •Adequate renal function: • Serum creatinine ≤1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min
- •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.
- •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:
- •Known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib excipients.
- •Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 isoenzymes within 7 days prior to study entry
- •Prior treatment with any CDK inhibitor.
- •Previous participation in a palbociclib trial.
- •Participation in other studies involving investigational drug(s) (Phases 1-4) within 2 weeks before the current study begins and/or during study participation.
- •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.
- •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.
- •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.
- •Active uncontrolled or symptomatic brain metastases.
- •Previously treated and clinically stable, as per Investigator’s judgment, brain metastases are permitted.
- •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.
- •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.
结局指标
主要结局
Percentage of patients with treatment-emergent adverse events (AEs) or serious adverse events (SAEs)
时间窗: Baseline up to 28 days after last dose of study treatment
次要结局
- Change from Baseline in Dimension Health State EuroQol (EQ-5D) Score(Baseline, Day 1 of each cycle up to 3 years)
- Objective Response(Baseline and per routine clinical practice to time of last dose of study treatment, up to 24 months)
研究者
研究点 (12)
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