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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02261389
• Other study ID #: KRONOS
• Secondary ID: PONS-S Italy
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2030

Study information

• Verified date: December 2022
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1507
• Est. completion date: December 2030
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Arm B, tumor markers assessment
Tumor markers assessment every three months through the study or until disease recurrence

Locations

Country	Name	City	State
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 Sanitaria dell'Alto Adige - Ospedale di Bressanone	Bressanone	Bolzano
Italy	Azienda Ospedaliero-Universitaria di Ferrara	Ferrara
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	IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia	Reggio Emilia

Sponsors (4)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna	Azienda ULSS 12 Veneziana, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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