Development of a New Remote Monitoring Model for Patients With HR+HER2- Breast Cancer in Treatment With CDK4/6 Inhibitors and Hormone Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Concordance between the results of the questionnaire and the clinical examination of the patients.
研究概览
简要总结
This study aims to develop and prospectively validate a questionnaire to select patients with breast cancer who need to access to hospital for clinical visit during treatment with CDK4/6i, to improve patients' quality of life and reduce burden of hospital accesses.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age ≥18 years old
- •Histologically or cytologically documented diagnosis of HR+, HER2-negative breast cancer based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent. HR+ tumor is defined as ER and/or PgR expression in greater than 1% of tumor cells. HER2-negative breast cancer is defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory).
- •Currently on treatment and have received ≥ 2 months of CDK4/6i + hormone therapy as their initial endocrine based treatment for their metastatic disease in concordance with local CDK4/6i label or treatment guideline.
- •No evidence of clinical or radiological disease progression per investigator assessment.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
排除标准
- •History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
- •Patient has a concurrent invasive malignancy and /or is concurrently using other anti-neoplastic therapy.
结局指标
主要结局
Concordance between the results of the questionnaire and the clinical examination of the patients.
时间窗: 12 months
This study will validate a questionnaire to select patients who need to access to hospital for clinical visit during treatment with CDK4/6i + hormone therapy for advanced breast cancer. Concordance between the results of the questionnaire (3 flags) and the clinical examination of the patients will be evaluated.
次要结局
未报告次要终点
研究者
Paris Ida
Head of Unit
Fondazione Policlinico Universitario Agostino Gemelli IRCCS