Clinical trial NCT02261389: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
follow-up
tumor markers
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany
name: Azienda ULSS 12 Veneziana
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
First posted: 2014-10-10
Enrollment: 1507
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time interval between date of randomization and date of diagnosis of disease distant recurrence
timeFrame: 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:
measure: Predefined critical difference of CEA and CA15-3
timeFrame: 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: Exploratory analysis in the different subtypes
timeFrame: 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: Imaging diagnostic tests evaluation
timeFrame: 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: Patient quality of life evaluation
timeFrame: 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
Other outcomes:
Locations:
city: Bressanone
country: Italy
facility: Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone
state: Bolzano
city: Merano
country: Italy
facility: Azienda Sanitaria dell'Alto Adige - Ospedale di Merano
state: Bolzano
city: Mirano
country: Italy
facility: ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica
state: Venezia
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
city: Bolzano
country: Italy
facility: Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
city: Reggio Emilia
country: Italy
facility: IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Bologna
name: Claudio Zamagni, MD
role: PRINCIPAL_INVESTIGATOR
References: