A Retrospective Observational Study of Adult Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib as Extended Adjuvant Therapy in the Context of the European Early Access Program (NEAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 25
- 主要终点
- Description of Age
研究概览
简要总结
The purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in Europe.
详细描述
Eligible patients were selected among those who had received at least one dose of neratinib in the context of the early access program conducted in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP. Patients were followed up until the end of the study observation period/study entry date (05 July 2022). As this study was retrospective, the decision to prescribe neratinib was taken prior to and independent of the proposal to select a patient for this study.
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
- •Patients will be eligible for inclusion if they fulfill all of the following criteria:
- •Age ≥ 18 years at neratinib treatment initiation
- •Having received at least one initial dose of neratinib as an extended adjuvant therapy for the treatment of early-stage HER2+ breast cancer, in the context of the EAP in Europe, and between August 01, 2017 and December 31, 2020
- •Patients (or next of kin/legal representative, if applicable) who provide written informed consent or non-opposition.
排除标准
- 未提供
结局指标
主要结局
Description of Age
时间窗: At baseline
Age will be assessed in years = neratinib initiation date - date of birth
Description of Gender
时间窗: At baseline
Gender will be described in percentage of Male and Female among patients
Description of BMI
时间窗: At baseline
BMI will be assessed in kg/m2
Menopausal Status
时间窗: At baseline
Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea
Comorbidities
时间窗: At baseline
Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity. Comorbidities were including but were not limited to: renal disease, liver disease, gastro-intestinal disorders, cardiovascular conditions, skin and subcutaneous disorders, diabetes (type I or II)
HER2 Overexpression/Amplification Testing
时间窗: At initial diagnosis
HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)
Hormone Receptor Status
时间窗: At initial diagnosis
Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative
Primary Tumor Location
时间窗: At initial diagnosis
Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer
Primary Tumor Histology
时间窗: At initial diagnosis
Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other
Histological Grade
时间窗: At initial diagnosis
Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated
Pathologic Stage (AJCC Classification) of Breast Cancer
时间窗: At initial diagnosis
Higher is the stage worse is the cancer. Stage is defined as: 1A: tumor (T) up to 2 cm + not spread outside the breast; no lymph nodes (LN).1B: Small clusters of cancer cells (CC) (0.2-2 mm) are found in LN, or T in the breast is \< 2 cm and small clusters of CC are found in LN. 2A: No T in the breast, but cancer is in 1-3 axillary LN or in LN near the breastbone or T is 2 cm or smaller + has spread to 1-3 axillary LN or LN near the breastbone, or T is \> 2 cm and \< 5 cm and not spread to LN.2B: T is \> 2 cm and \< 5 cm and has spread to 1-3 axillary LN or LN near the breastbone, or T is \> 5 cm and not spread to the LN. 3A: no T in the breast or the T is any size; cancer is found in 4-9 axillary LN or LN near the breastbone, or T is larger than 5 cm and small clusters of CC found in LN. 3B: T has spread to chest wall or breast skin + may have spread to up to 9 axillary LN. 3C: Cancer has spread to ≥10 axillary LN, LN near the collarbone, or LN near breastbone
次要结局
未报告次要终点