Multicenter Retrospective Observational (Descriptive) Study of Second-line Therapies After Progression to CDK4/6i in Association With Hormone Therapy, in Patients With HR+/HER2- Advanced Breast Cancer (HERMIONE 13)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 29
- 主要终点
- Description of the choices for second line treatment in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in association with hormonal therapy.
研究概览
简要总结
Description of the choices for second line treatment, in the normal clinical practice of the centers adhering to the Hermione Network, in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in association with hormonal therapy.
详细描述
Multicenter retrospective observational study, describing therapeutic choices as second-line treatment in patients with HR + / HER2- advanced breast cancer in a real world setting, in centers adhering to the Hermione Network.
The study involves the analysis of patients with HR + / HER2- advanced breast cancer treated in second line after initial treatment failure with aromatase inhibitor or Fulvestrant + CDK4 / 6i (Palbociclib, Ribociclib or Abemaciclib).
Data will be collected from 150 patients with at least one radiological re-evaluation of disease during 2nd-line treatment from 01 January 2016 until 31 December 2020.
List of collected information: Patients' characteristics (gender, age at diagnosis, menopausal state); Disease definition at diagnosis (stage, tumour histology, hormonal status); Surgery (date of surgery, type of surgical approach); Neo-adjuvant treatment; Adjuvant treatment; Date of first relapse (and time since the end of adjuvant therapy); Locations of metastases, Biopsy of metastases, Hormonal receptor status; First-line treatment, hormonal therapy, Best response, Cause of treatment end; Second-line treatment, Best response (radiological re-evaluation), Toxicity, Cause of treatment end.
Demographics, baseline characteristics (including tumor characteristics) and treatment information will be summarized descriptively. The categorical variables will be presented in the form of frequencies and percentages, while the continuous variables will be presented by mean, standard deviation and minimum and maximum values.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •age> 18 years
- •female sex
- •Performance Status (ECOG) 0-2;
- •hormonal-receptor positive breast cancer (Estrogen and / or Progesterone positive), HER2 negative, with evidence of stage IV / locally advanced inoperable disease
- •Radiologically documented progression in 1st line treatment with Hormonal Therapy (Aromatase inhibitor / Fulvestrant) + CDK4-6i (Palbociclib / Ribociclib / Abemaciclib)
- •Execution of at least one subsequent therapeutic line chosen by the clinician, with at least one radiological re-evaluation during this treatment by 31 December
- •Radiologically measurable or evaluable lesions
- •Written informed consent
排除标准
- •age <18 years
- •previous neoplastic pathology, within 5 years of the last active treatment
- •Previous chemotherapy treatments, with biological or endocrine therapies for advanced disease, different from first-line therapy with OT + CDK4 / 6i
结局指标
主要结局
Description of the choices for second line treatment in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in association with hormonal therapy.
时间窗: Entire study duration, approximately 12 months
Description of the choices for second line treatment, in the normal clinical practice of the centers adhering to the Hermione Network, in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in association with hormonal therapy.
次要结局
- Physician's reasons for treatment choice in real world experience(Entire study duration, approximately 12 months)
- Predictive factors of response(Entire study duration, approximately 12 months)
- progression-free survival(from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months)
- response rate(Entire study duration, approximately 12 months)
- Drug toxicities(Entire study duration, approximately 12 months)
- Survival Post Progression(from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months)
- progression by location (visceral versus non-visceral).(from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months)