breast cancer stage I breast cancer
Conditions
Interventions
None listed
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Female or male patients; • >= 18 years; • Written informed consent; • TNBC (defined as: invasive carcinoma; ER/PR expression 0-9%; HER2 negative [0, 1+ or 2+ on immunohistochemistry, without HER2 amplification on in-situ hybridization]) on the diagnostic biopsy and/or the surgical specimen; • Pathological stage I TNBC (according to the TNM staging 8th edition) • No evidence of nodal or distant metastases (cN0M0) on pre- and/or postoperative imaging examinations • sTIL score of >=50% for patients >=40 years at the time of TNBC diagnosis and >=75% for patients
Exclusion criteria
Exclusion criteria: • Prior disease history of invasive and/or non-invasive breast cancer, or ongoing treatment for invasive and/or non-invasive breast cancer; • Multifocal, multicentric or bilateral breast cancer at the time of screening; • Administration of neoadjuvant systemic therapy; • Presence of lymphovascular invasion (LVI) on the diagnostic biopsy and/or the surgical specimen; • Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DRFI, defined per Standardized Definitions for Efficacy End Points (STEEP) criteria as the time between inclusion and distant recurrence or death from breast cancer in the per-protocol population of the optimisation cohort | — |
Secondary
| Measure | Time frame |
|---|---|
| • Invasive disease-free survival (IDFS), defined per STEEP as the time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, death from any cause, invasive contralateral breast cancer or second primary invasive non-breast cancer in the per-protocol population of the optimisation cohort; • DRFS, defined per STEEP as the time between inclusion and first distant recurrence or death from any cause in per-protocol population of the optimisation cohort; • Recurrence-free survival (RFS), defined per STEEP as the time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the per-protocol population of the cohort; • OS, defined per STEEP as the time between inclusion and death from any cause in the per-protocol population of the optimisation cohort; • DRFI, IDFS, DRFS, RFS and OS in the intention-to-treat population of the optimisation cohort; • DRFI, IDFS, DRFS, RFS and OS in the control cohort; • HRQoL, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and EORTC QLQ-BR45 questionnaires, at baseline, 6 months, 1 year and 2 years after inclusion in the optimisation and control cohort; • Fear of recurrence and worries about health, assessed with the Health Distress (6 questions) and Health Awareness (2 questions) scales of the EORTC QLQ-SURV100 at baseline, 6 months, 1 year and 2 years after inclusion in the optimisation and control cohort (29); • Cost-effectiveness, measured as costs per Quality-Adjusted Life Years (QALYs) and incremental cost-effectiveness ratio (ICER) in the optimisation and control cohort. | — |
Countries
Belgium, Brazil, Germany, Ireland, Italy, Netherlands, Norway, Sweden
Contacts
Public ContactTW Volker
Nederlands Kanker Instituut
Outcome results
None listed