TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer

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

About this trial

This prospective, national, multi-centre study will include patients with stage III triple-negative breast cancer (TNBC) who are planned to start with standard (neo)adjuvant systemic treatment. The study will gather clinico-pathological, treatment and follow-up information of participating patients through Dutch databases. Participating patients will be asked to complete cancer specific and more generic quality of life questionnaires at nine time points during and after their anticancer treatment in a mobile application.

For all patients who have consented to additional blood collection, to assess the course of dynamic ctDNA during (neo)adjuvant chemotherapy and its relation with outcome, two tubes will be collected at four different time points.

Eligibility criteria

Qualifiers

Patients aged 18 years or older

Histologically confirmed adenocarcinoma of the breast

Assumed clinical or pathological stage III (TNM) breast cancer

HER2-negative: i.e. either score 0 or 1 at immunohistochemistry or score 2 at immunohistochemistry and negative at in situ hybridization (ISH, CISH or FISH)

Disqualifiers

Evidence of distant metastases. Staging examinations should have been performed according to Dutch national guidelines.

Patients who are only treated systemically in the adjuvant setting

Participation in another clinical study with an treatment intervention during the course of this study.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

The Netherlands Cancer Institute

Lead sponsor

Dutch Cancer Society

Collaborator