Three-monthly Dynamic Evaluation of CEA and CA 15.3 vs Usual Practice in the Follow-up of Early Breast Cancer Patients: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,507
- 试验地点
- 14
- 主要终点
- Time interval between date of randomization and date of diagnosis of disease distant recurrence
研究概览
简要总结
The main purpose of follow-up in asymptomatic breast cancer patients during and after adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local and distant recurrence compared to the usual follow-up practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years.
- •Histologically confirmed stage I-III epithelial breast cancer.
- •Adequate surgery of breast and axilla:
- •patients must have undergone either a total mastectomy or breast conserving surgery
- •surgical margins of the resected specimen must be histologically free of invasive tumor.
- •Cohort 1: if chemotherapy and/or radiotherapy are indicated the patients must be randomized between 1 month and 2 months from the end of chemotherapy and/or radiotherapy; if only hormonal adjuvant therapy is indicated the patients must be randomized within 3 months from the completion of surgery
- •Cohort 2: patients must be randomized in the trial after 5 years of follow-up without relapse (but within year 6)
- •Signed informed consent obtained prior to any study-specific procedures.
排除标准
- •Histologically confirmed stage 0 epithelial breast cancer (carcinoma in situ).
- •Special histologies with a high or low risk of relapse (i.e. sarcoma and tubular carcinoma)
- •T1a and T1b tumors with all the following characteristics: G1-2 and N0 and RE > 10%, RPg > 10% and HER2 negative and Ki67≤14%
- •Evidence of distant metastases
- •Patients participating to other clinical trials requiring follow-up not equal to standard
- •Previous history of cancer within 5 years from randomization (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above)
结局指标
主要结局
Time interval between date of randomization and date of diagnosis of disease distant recurrence
时间窗: Participants will be followed from date of randomization until the date of first documented disease distant recurrence or date of death from any cause, whichever came first, assessed up to 60 months
Primary objective of the study is to verify if the experimental arm (serial measurement of serum CEA and CA 15.3 with diagnostic imaging procedures - i.e. 18FDG-PET- performed only in case of critical increase of serum markers level) can anticipate the diagnosis of breast cancer loco-regional (except for in-breast recurrence) or distant metastases compared to the control arm (usual follow-up practice).
次要结局
- Predefined critical difference of CEA and CA15-3(Participants will be followed from date of randomization until the date of first documented disease distant recurrence or date of death from any cause, whichever came first, assessed up to 60 months)
- Exploratory analysis in the different subtypes(Participants will be followed from date of randomization until the date of first documented disease distant recurrence or date of death from any cause, whichever came first, assessed up to 60 months)
- Imaging diagnostic tests evaluation(Participants will be followed from date of randomization until the date of first documented disease distant recurrence or date of death from any cause, whichever came first, assessed up to 60 months)
- Patient quality of life evaluation(Participants will be followed from date of randomization until the date of first documented disease distant recurrence or date of death from any cause, whichever came first, assessed up to 60 months)
研究者
Claudio Zamagni MD
MD Medical Oncologist
IRCCS Azienda Ospedaliero-Universitaria di Bologna