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Active, Not Recruiting

NCT Number: NCT02261389

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone, Brixen, Bolzano, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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)

Treatment and study plan

Arm B, tumor markers assessment

Other

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

Other names: CEA, CA15-3, 18FDG-PET

Primary outcomes

  1. 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

    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).

Secondary outcomes

  1. 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 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.

  2. 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

    Secondary objective is to perform an exploratory analysis on diagnostic anticipation in the different subtypes (ER and HER2 status)

  3. 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

    Secondary objective is to measure how many imaging diagnostic tests will be avoided in the experimental arm compared to the control arm

  4. 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

    Secondary objective is to compare the quality of life in the two arms

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Collaborators

  • Azienda ULSS 12 Veneziana
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2026
Study completion
2030
First posted
Oct 10, 2014
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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