OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes
NCT Number: NCT06476119
Acronym: OPTImaL
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Stage I|Triple Negative Breast Cancer (TNBC)
Interventions: DRUG: Adjuvant chemotherapy|OTHER: No adjuvant chemotherapy
Sponsor: The Netherlands Cancer Institute
Collaborators: Maarten van de Weijden Foundation|AVL Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 490
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2034-09-15
Locations: Zuyderland Medisch Centrum, Sittard-Geleen, Limburg, 6162 BG, Netherlands|Medical spectrum Twente, Enschede, Overijssel, 7500 KA, Netherlands|Noordwest Ziekenhuisgroep, Alkmaar, Netherlands|Flevoziekenhuis, Almere, Netherlands|Meander Medisch Centrum, Amersfoort, Netherlands|Antoni van Leeuwenhoek, Amsterdam, 1066 CX, Netherlands|Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, Netherlands|Rijnstate, Arnhem, Netherlands|Amphia ziekenhuis, Breda, Netherlands|Haaglanden Medisch Centrum, Den Haag, Netherlands|Deventer Ziekenhuis, Deventer, Netherlands|Ziekenhuis Gelderse Vallei, Ede, Netherlands|Catharina Ziekenhuis, Eindhoven, Netherlands|Jeroen Bosch ziekenhuis, Eindhoven, Netherlands|St. Jansdal, Harderwijk, Netherlands|Ziekenhuisgroep Twente, Hengelo, Netherlands|Tergooi ziekenhuizen, Hilversum, Netherlands|Spaarne Gasthuis, Hoofddorp, Netherlands|Dijklander ziekenhuis, Hoorn, Netherlands|MCL, Leeuwarden, 8934 AD, Netherlands|LUMC, Leiden, Netherlands|MUMC, Maastricht, Netherlands|St. Antonius ziekenhuis, Nieuwegein, Netherlands|Radboud UMC, NIjmegen, 6225GA, Netherlands|Erasmus Medical Center Cancer Institute, Rotterdam, 3015CE, Netherlands|Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands|VieCuri Medisch Centrum voor Noord-Limburg, Venlo, Netherlands|Isala, Zwolle, Netherlands

Summary:
The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment. In addition, the investigation looks at whether the omission of chemotherapy ensures a better quality of life. Participants decide, in consultation with their treating physician, whether they choose to be treated with adjuvant chemotherapy or not.

Primary Outcome Measures: Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population, Number of patients with distant recurrence or death in per-protocol population of the optimisation cohort, up to 96 months after inclusion of the last patient
Secondary Outcome Measures: Disease recurrence Free Interval (DRFI) - optimalisation cohort intention to treat population, Number of patients with distant recurrence or death in intention to treat population of the optimisation cohort, up to 96 months after inclusion of the last patient|Disease recurrence Free Interval (DRFI) - control cohort, Number of patients with distant recurrence or death in control cohort, up to 96 months after inclusion of the last patient|Invasive disease-free survival (IDFS) - optimalisation cohort per-protocol population, Number of patients with breast tumor recurrence or death in the per-protocol population of the optimisation cohort, up to 96 months after inclusion of the last patient|Invasive disease-free survival (IDFS) - optimalisation cohort intention-to-treat population, Number of patients with breast tumor recurrence or death in the the intention-to-treat population of the optimisation cohort, up to 96 months after inclusion of the last patient|Invasive disease-free survival (IDFS) - control cohort, Number of patients with breast tumor recurrence or death in the control cohort, up to 96 months after inclusion of the last patient|disease recurrence free survival (DRFS) - optimalisation cohort per-protocol population, time between inclusion and first distant recurrence or death from any cause in the per-protocol population of the optimisation cohort, up to 96 months after inclusion of the last patient|disease recurrence free survival (DRFS) - optimalisation cohort the intention-to-treat population, time between inclusion and first distant recurrence or death from any cause in the intention-to-treat population of the optimisation cohort population of the optimisation cohort, up to 96 months after inclusion of the last patient|disease recurrence free survival (DRFS) - control cohort, time between inclusion and first distant recurrence or death from any cause in the control cohort, up to 96 months after inclusion of the last patient|Recurrence-free survival (RFS) - optimalisation cohort per-protocol population, 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 optimisation cohort;, up to 96 months after inclusion of the last patient|Recurrence-free survival (RFS) - optimalisation cohort the intention-to-treat population, time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the the intention-to-treat population of the optimisation cohort;, up to 96 months after inclusion of the last patient|Recurrence-free survival (RFS) - control cohort, time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the control cohort;, up to 96 months after inclusion of the last patient|Overal Survival (OS) - optimalisation cohort per-protocol population, time between inclusion and death from any cause in the per-protocol population of the optimisation cohort;, up to 96 months after inclusion of the last patient|Overal Survival (OS) - optimalisation cohort intention-to-treat population, time between inclusion and death from any cause in the the intention-to-treat population of the optimisation cohort;, up to 96 months after inclusion of the last patient|Overal Survival (OS) - control cohort, time between inclusion and death from any cause in the control cohort;, up to 96 months after inclusion of the last patient|Health related Quality of Life (HRQoL) - (European Organisation on Research and Treatment of Cancer) EORTC questionnaire QLQ-C30, Difference in QoL assessed with the EORTC QLQ-C30 questionnaires between the optimisation and the control group. A higher score indicates a higher symptom burden., up to 2 years after inclusion|Health related Quality of Life (HRQoL) - (European Organisation on Research and Treatment of Cancer) EORTC questionnaire QLQ-BR45, Difference in QoL assessed with the EORTC QLQ-BR45 questionnaires between the optimisation and the control group. A higher score indicates a higher symptom burden., up to 2 years after inclusion|Fear of recurrence, Assessed with questionnaires to determine the difference in optimisation and control group, up to 2 years after inclusion|Worries about health, Assessed with questionnaires to determine the difference in optimisation and control group. A higher score indicates a higher symptom burden., up to 2 years after inclusion|Cost effectiveness measured by quality-adjusted-life years (QALYs), Measured per Quality-Adjusted Life Years (QALYs), up to 2 years after inclusion|Cost effectiveness measured per incremental cost-effectiveness ratio (ICER), Measured per incremental cost-effectiveness ratio (ICER), up to 2 years after inclusion