Prospective, Non-interventional, Non-controlled Multicenter Observational Study to Evaluate Aspects of Pharmaceutical Care and the Treatment of Postmenopausal Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer Treated With Everolimus and Exemestane.
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Medication adherence
研究概览
简要总结
A prospective, non-interventional, non-controlled multicenter observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with everolimus and exemestane.
The main objective of the study is to evaluate medication adherence in postmenopausal, hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a combination of everolimus and exemestane. Additionally, other aspects of the pharmacotherapy, with focus on the patient perspective, will be investigated:
- Patient satisfaction with treatment information
- Patient satisfaction with treatment
- Health-related quality of life
- Treatment efficacy
- Treatment-related toxicity
- Patient follow-up by the oncologic team/general practitioner and or specialized home nurses
This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women, 18 years or older
- •Signed written informed consent
- •Patient can be contacted by phone and/or e-mail
- •HR+, HER2- advanced or metastatic breast cancer
- •Recurrence or progression following a non-steroidal aromatase inhibitor
- •Able to swallow and retain oral medication
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
排除标准
- •Patients who are not able to understand Dutch or French
- •Symptomatic visceral metastatic disease
- •Patients who have taken an investigational drug within 28 days or 5 half-lives, whichever is shorter, prior to recruitment
- •Current use of a prohibited medication as described in the SPC
- •Any serious or unstable pre-existing medical conditions, psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedure
- •Hypersensitivity to the active substances or to any of the excipients
结局指标
主要结局
Medication adherence
时间窗: one year
At the first visit patients will receive their anti-cancer medication by the hospital in two separate pill boxes which electronically record openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in these chips will be read in the hospital pharmacy each time the patient gets new capsules. This information is strictly confidential and can only be consulted by the research team at the KULeuven.
次要结局
- Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)(one year)
- Morisky Medication Adherence Scale (MMAS)(one year)
- Cancer Therapy Satisfaction Questionnaire (CTSQ)(one year)
- Functional Assessment of Cancer Therapy - for patients with breast cancer (FACT-B)(one year)
- Tumor status evaluation(one year)
- Performance status of the patient(one year)
- Toxicity of treatment(one year)