About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Adjuvant chemotherapy
- No adjuvant chemotherapy
Treatment groups
Sponsors and collaborators
The Netherlands Cancer Institute
Lead sponsor
Maarten van de Weijden Foundation
Collaborator
AVL Foundation
Collaborator