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Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Arm B, tumor markers assessment
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, follow-up, tumor markers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone
  • Azienda Sanitaria dell'Alto Adige - Ospedale di Merano
  • ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica
  • Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
  • Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano
  • Azienda Ospedaliero-Universitaria di Ferrara
  • IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm A, usual follow-up practice

Arm B, tumor markers assessment

Arm Description

Imaging studies and serum markers (CEA, CA 15.3, others) performed according to local practice

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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)
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
Patient quality of life evaluation
Secondary objective is to compare the quality of life in the two arms

Full Information

First Posted
September 30, 2014
Last Updated
December 28, 2022
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany, Azienda ULSS 12 Veneziana, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT02261389
Brief Title
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2014 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany, Azienda ULSS 12 Veneziana, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, follow-up, tumor markers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A, usual follow-up practice
Arm Type
No Intervention
Arm Description
Imaging studies and serum markers (CEA, CA 15.3, others) performed according to local practice
Arm Title
Arm B, tumor markers assessment
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Arm B, tumor markers assessment
Other Intervention Name(s)
CEA, CA15-3, 18FDG-PET
Intervention Description
Tumor markers assessment every three months through the study or until disease recurrence
Primary Outcome Measure Information:
Title
Time interval between date of randomization and date of diagnosis of disease distant recurrence
Description
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).
Time Frame
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
Secondary Outcome Measure Information:
Title
Predefined critical difference of CEA and CA15-3
Description
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.
Time Frame
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
Title
Exploratory analysis in the different subtypes
Description
Secondary objective is to perform an exploratory analysis on diagnostic anticipation in the different subtypes (ER and HER2 status)
Time Frame
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
Title
Imaging diagnostic tests evaluation
Description
Secondary objective is to measure how many imaging diagnostic tests will be avoided in the experimental arm compared to the control arm
Time Frame
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
Title
Patient quality of life evaluation
Description
Secondary objective is to compare the quality of life in the two arms
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Zamagni, MD
Organizational Affiliation
Azienda Ospedaliero-Universitaria di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone
City
Bressanone
State/Province
Bolzano
ZIP/Postal Code
39042
Country
Italy
Facility Name
Azienda Sanitaria dell'Alto Adige - Ospedale di Merano
City
Merano
State/Province
Bolzano
ZIP/Postal Code
39012
Country
Italy
Facility Name
ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica
City
Mirano
State/Province
Venezia
ZIP/Postal Code
30035
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET

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