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

NCT02261389 | Active Not Recruiting DMC

• 2 other identifiers: KRONOSPONS-S Italy
• Study Type: interventional
• Target: 1,507
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

breast cancer; follow-up; tumor markers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Predefined critical difference of CEA and CA15-3

  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

  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

  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

  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

Study Arms (2)

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.

Other: Arm B, tumor markers assessment

Interventions

Arm B, tumor markers assessment OTHER

Tumor markers assessment every three months through the study or until disease recurrence

Also known as: CEA, CA15-3, 18FDG-PET

Arm B, tumor markers assessment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany: collaborator
• Azienda ULSS 12 Veneziana: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator

Study Sites (7)

Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone

Brixen, Bolzano, 39042, Italy

Location

Azienda Sanitaria dell'Alto Adige - Ospedale di Merano

Merano, Bolzano, 39012, Italy

Location

ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica

Mirano, Venezia, 30035, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii

Bologna, 40138, Italy

Location

Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano

Bolzano, 39100, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

Location

IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mucin-1

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Mucins; Mucoproteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Tumor-Associated, Carbohydrate; Antigens, Neoplasm; Antigens; Biological Factors; Epitopes; Biomarkers, Tumor; Biomarkers

Study Officials

• Claudio Zamagni, MD

  Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Medical Oncologist

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 10, 2014
• Study Start: September 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

IT (7)