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| ID | Type | Description | Link |
|---|---|---|---|
| PONS-S Italy | Other Identifier | S.Orsola-Malpighi Hospital |
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| Name | Class |
|---|---|
| PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany | UNKNOWN |
| Azienda ULSS 12 Veneziana | OTHER |
| Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A, usual follow-up practice | No Intervention | Imaging studies and serum markers (CEA, CA 15.3, others) performed according to local practice | |
| Arm B, tumor markers assessment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm B, tumor markers assessment | Other | Tumor markers assessment every three months through the study or until disease recurrence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time interval between date of randomization and date of diagnosis of disease distant recurrence | 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Predefined critical difference of CEA and CA15-3 | Secondary objective is to evaluate the Positive Predictive Value (PPV) and the Negative Predictive Value (NPV) of CEA and CA15.3 dynamic changes in the diagnosis of breast cancer loco-regional (except for in-breast recurrence) or distant metastases. | 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 |
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Inclusion Criteria:
Male or female ≥18 years.
Histologically confirmed stage I-III epithelial breast cancer.
Adequate surgery of breast and axilla:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Zamagni, MD | Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone | Brixen | Bolzano | 39042 | Italy | ||
| Azienda Sanitaria dell'Alto Adige - Ospedale di Merano |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D018396 | Mucin-1 |
| ID | Term |
|---|---|
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Exploratory analysis in the different subtypes | Secondary objective is to perform an exploratory analysis on diagnostic anticipation in the different subtypes (ER and HER2 status) | 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 | Secondary objective is to measure how many imaging diagnostic tests will be avoided in the experimental arm compared to the control arm | 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 | Secondary objective is to compare the quality of life in the two arms | 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 |
| Merano |
| Bolzano |
| 39012 |
| Italy |
| ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica | Mirano | Venezia | 30035 | Italy |
| Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii | Bologna | 40138 | Italy |
| Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano | Bolzano | 39100 | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | 44124 | Italy |
| IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia | Reggio Emilia | 42123 | Italy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009077 |
| Mucins |
| D009088 | Mucoproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D015295 | Antigens, Tumor-Associated, Carbohydrate |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D000939 | Epitopes |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |