Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region Like Saudi Arabia, UAE and Other GCC Countries: A Retrospective Study (Treasure Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 258
- 试验地点
- 11
- 主要终点
- Number of participants with dose changes associated with palbociclib use
研究概览
简要总结
retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2- metastatic/locally advanced breast cancer (BC)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old.
- •HR+/HER2- BC diagnosis with confirmed metastatic/locally advanced disease.
- •Patient initiated on palbociclib (regardless the line of therapy) within the period between 01st January 2015 and 01st March
- •Minimum of six months of follow up data since palbociclib initiation.
- •Received palbociclib plus aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s).
排除标准
- •Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC.
- •Patients who were initiated on palbociclib after 01st March 2019.
研究组 & 干预措施
palbociclib plus fulvestrant
Adult metastatic breast cancer patients who initiated Palbociclib + fulvestrant. Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019.
Aligned with Locally Approved Indication
干预措施: Palbociclib plus fulvestrant (Drug)
Palbociclib plus an aromatase inhibitor
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor.
Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019.
Aligned with Locally Approved Indication
干预措施: Palbociclib plus an aromatase inhibitor (Drug)
结局指标
主要结局
Number of participants with dose changes associated with palbociclib use
时间窗: From 01 January 2015 to 30 September 2019
Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.
Demographical Characteristics of Participants: Biomarker status
时间窗: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Biomarker status - (estrogen receptor \[ER\], progesterone receptor \[PR\], HER-2 neu, Ki67, Germline BRCA \[gBRCA\] testing).
Number of participants to discontinue treatment associated with palbociclib use
时间窗: From 01 January 2015 to 30 September 2019
Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.
Number of participant receiving supportive therapies while receiving palbociclib combination treatment
时间窗: From 01 January 2015 to 30 September 2019
Supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis while receiving palbociclib combination treatments. Duration of treatments.
Proportion of patients who are progression free at multiple intervals
时间窗: From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 57 months
Proportion of progression free survival/time to progression (at intervals per standard of care) (eg. 12, 18 months).
Proportion of patients alive 1 and 2 years post palbociclib combination initiation depending on availability of follow-up data (if available)
时间窗: From 01 January 2015 to 30 September 2019
Clinical Characteristics of Participants: Description of diagnosis
时间窗: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Description of diagnosis - staging, node status, menopause status, diagnosis for which palbociclib combination was prescribed, sites of metastases, de novo vs. recurrent disease.
Number of patients receiving adjuvant therapies
时间窗: Upon diagnosis of BC (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) (if available)
Objective response rate (ORR)
时间窗: From date of index treatment up to 57 months
Proportion of objective response rate (at intervals per standard of care).
Demographical Characteristics of Participants
时间窗: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Number of participants receiving treatment for advanced/metastatic BC before and after palbociclib combination use
时间窗: Upon diagnosis of metastatic/locally advanced HR+/HER2 BC for a maximum of 4 years approximately (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Treatments and supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis. Duration of treatments. Reasons for regimen changes. Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible reasons for change in treatment. Line of treatment.
次要结局
未报告次要终点