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.
Female or male patients;
>=18 years;
Written informed consent;
TNBC (defined as: invasive carcinoma; ER/PR expression 0-9%; Human Epidermal Growth Factor Receptor 2 [HER2] negative [0, 1+ or 2+ on immunohistochemistry, without HER2 amplification on in-situ hybridization]) on the diagnostic biopsy and the surgical specimen;
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 on the diagnostic biopsy and/or the surgical specimen;
patients with pathological stage I TNBC (pT1a/b/cN0) and a high sTIL score (defined as ≥50% for patients ≥40 years; ≥75% for patients \<40 years)
Cohort
Prospective
Adjuvant chemotherapy
Drugadjuvant chemotherapy according to local/ national guidelines
No adjuvant chemotherapy
Other interventionno adjuvant chemotherapy
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
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
Disease recurrence Free Interval (DRFI) - control cohort
Number of patients with distant recurrence or death in control cohort
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
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
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The Netherlands Cancer Institute
Lead sponsor
Maarten van de Weijden Foundation
Collaborator
AVL Foundation
Collaborator
