Breast CancerNCT02261389
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
A study testing Arm B, tumor markers assessment in people with Breast Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 7 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Arm B, tumor markers assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,507 participants
- Where
- 7 sitesItaly
- Study dates
- Sep 2014to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna, 40138
Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano
Bolzano, 39100
Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone
Brixen, Bolzano, 39042
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, 44124
Azienda Sanitaria dell'Alto Adige - Ospedale di Merano
Merano, Bolzano, 39012
ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica
Mirano, Venezia, 30035
IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia
Reggio Emilia, 42123
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- Arm B, tumor markers assessment
- Keywords
- breast cancer, follow-up, tumor markers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm B, tumor markers assessmentOther
Also called CEA, CA15-3, 18FDG-PET
Tumor markers assessment every three months through the study or until disease recurrence
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Arm B, tumor markers assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (4)
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.
Measured: 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
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)
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,507 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany, Azienda ULSS 12 Veneziana, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Responsible party
- Principal investigator, Claudio Zamagni MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Claudio Zamagni, MD, Principal investigator, Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261389
- Sponsor's protocol ID
- KRONOS
- Other IDs
- PONS-S Italy
- Status last verified
- Dec 2022
- First submitted
- 30 Sep 2014
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02261389
- Acronym / sponsor ID
- KRONOS
- Conditions
- Breast Cancer
- Keywords
- breast cancer, follow-up, tumor markers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,507 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany, Azienda ULSS 12 Veneziana, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Study start
- Sep 2014 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Arm B, tumor markers assessmentSerum 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm B, tumor markers assessmentAlso: CEA, CA15-3, 18FDG-PETTumor markers assessment every three months through the study or until disease recurrence | Other | Arm B, tumor markers assessment |
Primary outcome
Time interval between date of randomization and date of diagnosis of disease distant recurrence
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
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).
4 secondary outcomes
Predefined critical difference of CEA and CA15-3
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
Exploratory analysis in the different subtypes
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
Imaging diagnostic tests evaluation
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
Patient quality of life evaluation
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Zamagni, MD principal investigator
Azienda Ospedaliero-Universitaria di Bologna
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm B, tumor markers assessment in people with Breast Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval between date of randomization and date of diagnosis of disease distant recurrence (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.