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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT02261389
• Date of registration: 30/09/2014
• Prospective Registration: No
• Primary sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Public title: Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
• Scientific 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
• Date of first enrolment: September 2014
• Target sample size: 1507
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02261389
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Claudio Zamagni, MD
• Affiliation: Azienda Ospedaliero-Universitaria di Bologna

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Other: Arm B, tumor markers assessment

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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]

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]

Secondary ID(s)

PONS-S Italy

KRONOS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Azienda ULSS 12 Veneziana

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany