Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
NCT ID: NCT02261389
Last Updated: 2022-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1507 participants
INTERVENTIONAL
2014-09-30
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm A, usual follow-up practice
Imaging studies and serum markers (CEA, CA 15.3, others) performed according to local practice
No interventions assigned to this group
Arm B, tumor markers assessment
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.
Arm B, tumor markers assessment
Tumor markers assessment every three months through the study or until disease recurrence
Interventions
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Arm B, tumor markers assessment
Tumor markers assessment every three months through the study or until disease recurrence
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
FEMALE
No
Sponsors
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PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany
UNKNOWN
Azienda ULSS 12 Veneziana
OTHER
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Claudio Zamagni MD
MD Medical Oncologist
Principal Investigators
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Claudio Zamagni, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Bologna
Locations
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Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone
Brixen, Bolzano, Italy
Azienda Sanitaria dell'Alto Adige - Ospedale di Merano
Merano, Bolzano, Italy
ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica
Mirano, Venezia, Italy
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
Countries
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Other Identifiers
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PONS-S Italy
Identifier Type: OTHER
Identifier Source: secondary_id
KRONOS
Identifier Type: -
Identifier Source: org_study_id