OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

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

490 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The Netherlands Cancer Institute

Lead sponsor

Maarten van de Weijden Foundation

Collaborator

AVL Foundation

Collaborator