Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer (CLEAR-B)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Comparison of iDFS
研究概览
简要总结
This is a non-interventional retrospective cohort study of premenopausal patients with HR+/HER2- breast cancer who are treated in the adjuvant setting with either Tamoxifen, Tamoxifen + Ovarial Function Suppression or Aromatase inhibitor + Ovarial Function Suppression.
详细描述
The treatment landscape concerning the adjuvant endocrine therapy in premenopausal patients with early-stage hormone receptor positive (HRpos) breast cancer is quite heterogeneous and therapy recommendations can vary. Tamoxifen (TAM) is a common treatment option that does not require OFS, but research suggests that adding OFS to tamoxifen may improve outcomes. Aromatase inhibitors (AI) are another option, but they can only be used with OFS for premenopausal patients. Studies have shown that AI + OFS improves disease-free survival compared to TAM + OFS, but it may lead to additional side effects such as osteopenia and bone fractures.
The CLEAR-B study aims to provide a detailed description of the therapy landscape in this therapeutic setting, including recurrence rates and overall survival with AI compared to TAM, as well as a comparison of the chosen therapies within prognostic subgroups.
CLEAR-B is a retrospective cohort study, collecting data of premenopausal patients who were diagnosed with early-stage breast cancer between January 2016 and June 2019 in a certified breast cancer center. These patients had an intermediate or high risk of cancer recurrence, as defined by (neo)adjuvant chemotherapy, and/or pT≥2cm at the timepoint of definitive surgery and/or at least one positive lymph node at the time of definite surgery (pN+).
The primary objective is to compare the invasive disease-free survival (iDFS) of patients who were treated with AI + OFS vs. those who were treated with TAM ± OFS. Additionally, the study will compare distant disease-free survival (DDFS) and overall survival (OS) between the two groups and perform subgroup analyses according to risk stratification (stage II and III). This study will be conducted at around 75 certified breast cancer centers and will enroll up to 3000 patients.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with a first primary diagnosis of hormone receptor-positive, HER2- negative unilateral early breast cancer for whom an endocrine treatment is indicated
- •Patients must be at least 18 years of age but not older than 60
- •Premenopausal defined as all statements must be true
- •No oophorectomy before the diagnosis of breast cancer
- •Women with uterus: Regular, physiological menses at the timepoint of therapy decision for anti-endocrine treatment in the absence of contraceptives and hormonal treatment
- •Women without uterus and remaining ovaries: premenopausal hormone levels must be documented at the time of therapy decision for anti-endocrine treatment
- •Patients with an intermediate or high-risk early-stage breast cancer defined as: At least one of the following must be fulfilled
- •(Neo)adjuvant chemotherapy
- •pT≥2cm at the timepoint of definitive surgery
- •at least one positive lymph node at the time of definite surgery (pN+)
- •Patient must be previously registered in and must have been documented as part of the certification process for a certified breast cancer center according to the Deutsche Krebsgesellschaft/Deutsche Gesellschaft für Senologie
- •Breast Cancer must have been diagnosed between Jan 2016 and Jun 2019
排除标准
- •Patients with a low recurrence risk (see inclusion criteria for definition)
- •Locally advanced breast cancer or distant metastases at diagnosis
- •Male biological sex
- •Patients not treated in a certified breast cancer center
- •Treatment with CDK4/6Previous diagnosis of invasive breast cancer or in situ breast cancer
- •Concurrent invasive malignancy
- •Bilateral breast cancer at the timepoint of diagnosis
- •Previous diagnosis of invasive breast cancer or in situ breast cancer is not allowed
结局指标
主要结局
Comparison of iDFS
时间窗: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
In case non-inferiority is confirmed, the superiority of Cohort AI+OFS over Cohort TAM will be tested with regard to iDFS. iDFS will be assessed as time to event. Events for iDFS include: Invasive Ipsilateral Breast Tumor Recurrence (IBTR), Local/Regional Invasive Recurrence, Distant Recurrence, Death from BC, Death from Non-BC Cause, Death From unknown cause, Invasive Contralateral BC, Second Primary Invasive Cancer (non-breast)
iDFS
时间窗: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
The primary study aim is to show that aromatase inhibitor (AI) based treatments (AI arm) are not inferior to treatments based on tamoxifen (tamoxifen arm) in terms of invasive diseasefree survival (iDFS). iDFS will be assessed as time to event. Events for iDFS include: Invasive Ipsilateral Breast Tumor Recurrence (IBTR), Local/Regional Invasive Recurrence, Distant Recurrence, Death from BC, Death from Non-BC Cause, Death From unknown cause, Invasive Contralateral BC, Second Primary Invasive Cancer (non-breast)
次要结局
- Comparison of OS(First start of adjuvant endocrine therapy until date of death up to 5 years)
- Risk Factors(Baseline until onset of disease progression or death up to 5 years)
- Comparison of DDFS(First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years)
- Comparison of iDFS in Cohort TAM(First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years)
- Comparison of iDFS (TAM+OFS and AI+OFS)(First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years)
- Comparison of DDFS (TAM+OFS and AI+OFS)(First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years)
- Comparison of DDFS (TAM-OFS and AI+OFS)(First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years)
- Comparison of OS in Cohort TAM(First start of adjuvant endocrine therapy until date of death up to 5 years)
- Comparison of OS (TAM-OFS and AI+OFS)(First start of adjuvant endocrine therapy until date of death up to 5 years)
- NATALEE Comparison(Baseline until onset of disease progression or death up to 5 years)
- Comparison of DDFS in Cohort TAM(First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years)
- Comparison of iDFS (TAM-OFS and AI+OFS)(First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years)
- Influence of disease stage(Baseline until onset of disease progression or death up to 5 years)
- Comparison of OS (TAM+OFS and AI+OFS)(First start of adjuvant endocrine therapy until date of death up to 5 years)