Status:
ACTIVE_NOT_RECRUITING
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany
Azienda ULSS 12 Veneziana
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2030
Estimated Enrollment :
1507 Patients enrolled
Trial Details
Trial ID
NCT02261389
Start Date
September 1 2014
End Date
December 1 2030
Last Update
December 29 2022
Active Locations (7)
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1
Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone
Brixen, Bolzano, Italy, 39042
2
Azienda Sanitaria dell'Alto Adige - Ospedale di Merano
Merano, Bolzano, Italy, 39012
3
ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica
Mirano, Venezia, Italy, 30035
4
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna, Italy, 40138