STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POSTMENOPAUSAL 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
- 发起方
- Pfizer
- 入组人数
- 131
- 试验地点
- 24
- 主要终点
- Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin American countries before it becomes commercially available to patients with HR positive/HER2-negative ABC who are appropriate candidates for letrozole therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 主要目的
- Treatment
- 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
- •Adult women with proven diagnosis of advanced adenocarcinoma of the breast (locoregional recurrent or metastatic disease).
- •Women who are not of childbearing potential.
- •ER-positive and/or Progesterone receptor (PgR)-positive tumor based on local laboratory results (test as per local practice).
- •HER2-negative breast cancer based on local laboratory results (test as per local practice or local guidelines).
- •Patients must be appropriate candidates for letrozole therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Adequate bone marrow function.
- •Adequate liver function
- •Adequate renal function.
排除标准
- •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 clinical study.
- •Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.
- •QTc >480 msec; 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 prior to enrollment.
- •Diagnosis of any second invasive malignancy within the last 3 years prior to enrollment. Note: patients with adequately treated basal cell or squamous cell skin cancer, a history of intraepithelial neoplasia or in situ disease (eg, carcinoma in situ of the cervix or melanoma in situ) may enter.
- •Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, brain metastases are permitted.
- •Other severe acute or chronic medical or psychiatric conditions.
- •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.
研究组 & 干预措施
Palbociclib + Letrozole
palbociclib and letrozole combination
干预措施: Palbociclib (Drug)
Palbociclib + Letrozole
palbociclib and letrozole combination
干预措施: Letrozole (Drug)
结局指标
主要结局
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs)
时间窗: 3 years
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Number of Participants With Palbociclib-related TEAEs
时间窗: 3 years
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Palbociclib-related TEAEs were determined by the investigator.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: 3 years
An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. Palbociclib-related SAEs were determined by the investigator.
次要结局
- Number of Participants With Death(3 years)
- The Objective Response Rate (ORR)(3 years)