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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Arm B, tumor markers assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02261389

PONS-S Italy (Other Identifier)

KRONOS

Details and patient eligibility

About

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.

Enrollment: 1,507 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,507 participants in 2 patient groups

Arm A, usual follow-up practice

No Intervention group

Description:

Imaging studies and serum markers (CEA, CA 15.3, others) performed according to local practice

Arm B, tumor markers assessment

Experimental group

Description:

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.

Treatment:

Other: Arm B, tumor markers assessment