Clinical trial · Interventional
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm B, tumor markers assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm A, usual follow-up practice
- description
- Imaging studies and serum markers (CEA, CA 15.3, others) performed according to local practice
- type
- EXPERIMENTAL
- label
- Arm B, tumor markers assessment
- description
- Serum CEA and CA 15.3 performed every 3 months. No imaging studies allowed in asymptomatic patients: imaging studies (18 FDG-PET) performed only in case of critical increase of CEA and /or CA 15.3 serum levels (+100% for CEA and +75% for CA15.3), even if in the normal range.
- interventionNames
- Other: Arm B, tumor markers assessment
Primary outcomes (1)
- measure
- Time interval between date of randomization and date of diagnosis of disease distant recurrence
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ≥18 years. * Histologically confirmed stage I-III epithelial breast cancer. * Adequate surgery of breast and axilla: 1. patients must have undergone either a total mastectomy or breast conserving surgery 2. 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. Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available