Clinical Trials in Italy / NCT02261389
Active, not recruiting
Not applicable
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
NCT02261389 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Breast Cancer
Investigational drug(s) / intervention(s)
Arm B, tumor markers assessment
Arm B, tumor markers assessment: Tumor markers assessment every three months through the study or until disease recurrence
Study summary
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.
Eligibility
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)
Primary outcome measure(s)
- Time interval between date of randomization and date of diagnosis of disease distant recurrence — 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).
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone | Brixen | Bolzano | |
| Azienda Sanitaria dell'Alto Adige - Ospedale di Merano | Merano | Bolzano | |
| ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica | Mirano | Venezia | |
| Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii | Bologna | Italy | |
| Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano | Bolzano | Italy | |
| Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | Italy | |
| IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia | Reggio Emilia | Italy |
More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy
Other trials for the same condition
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)
Active, not recruiting
The OPBC-07/microNAC Study
Active, not recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study
Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT)
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02261389 on ClinicalTrials.gov ↗ ← All trials in Italy