Registry for Long-term Follow-up of Safety and Efficacy Parameters of GBG Study Participants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 26
- 主要终点
- Invasive disease-free survival (iDFS)
研究概览
简要总结
The ETERNITY study is an international, multicenter, observational study that aims to follow up patients who have participated in a GBG trial for early breast cancer, even after the study has officially ended, in order to collect long-term data on survival, late or delayed adverse events, in addition to information related to pregnancy, fertility and other parameters impacting quality of life.
详细描述
This is a prospective and retrospective, international, multicenter, non-interventional, observational study for collection of long-term safety and efficacy parameters of former GBG study participants of prospective clinical trials on early breast cancer.
Patients with prospective data collection will be informed about the registry by the treating physician at the study site. After written informed consent (which may already be included in the main and/or biomaterial informed consent form of the respective clinical study) for data and biomaterial collection, the registration form will be filled out completely within the GBG electronic data capture system (MEDCODES®). Inclusion and registration can take place after informed consent of the patient. However, documentation of follow-up should start after the regular end of study or with the start of the follow-up period, as defined in the respective study protocol.
A correlation of the follow-up registry database with the respective study databases is possible via the patient identification number of the participant. Consequently, the long-term effects of the study therapy can be calculated per therapy group, and the effectiveness can be correlated with possible late-onset toxicities.
Post-study long-term outcome follow-up will be assessed according to local/national guidelines for standard follow-up examinations and post-treatment surveillance. Data should be documented at least once a year in the registry.
Relapse and safety assessment will be performed, and survival status will be collected in all registered patients. Here, the investigator may conduct evaluations or assessments within regular follow-up visits. However, telephone contact or contact in writing with the patient or treating physician or relatives in case of death is also acceptable. Imaging tests (e.g., mammography and/or staging workup) are recommended according to local/national guidelines for follow-up and in case of symptoms suspicious for locoregional or distant relapse.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Participation and treatment in a GBG clinical trial for early breast cancer.
- •Prospective registration: Written informed consent according to local regulatory requirements prior to data and biomaterial collection.
排除标准
- •Participation and treatment in a non-GBG clinical trial for early breast cancer.
- •Patients with advanced or metastatic breast cancer who have participated and received treatment in a GBG clinical trial.
结局指标
主要结局
Invasive disease-free survival (iDFS)
时间窗: 10 years
Time period between randomization and first event (ipsi- or contralateral invasive in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast))
Distant disease-free survival (DDFS)
时间窗: 10 years
Time period between randomization and diagnosis of any distant recurrence of disease, any second primary invasive cancer (non-breast) or death due to any cause, whichever occurs first
Overall survival (OS)
时间窗: 10 years
Time period between randomization and death of any cause
Disease-free survival (DFS)
时间窗: 10 years
Time period between randomization and first event (ipsi- or contralateral (non-) in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast))
Locoregional recurrence-free survival (LRRFS)
时间窗: 10 years
Time period between randomization and diagnosis of any loco-regional (ipsilateral breast (invasive or DCIS), local/regional lymph nodes) recurrence of disease, any invasive contralateral breast cancer or death due to any cause, whichever occurs first
Other primary outcome measures
时间窗: 10 years
Other study-specific long-term survival endpoints may be defined in the respective study protocol or statistical analysis plan (SAP)
次要结局
- Pregnancies(10 years)
- Anti-cancer therapies(10 years)
- Impact of study treatment on Quality of Life (QoL)(10 years)
- Long-term toxicity(10 years)