TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
Recruiting now
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06931769
- Run by
- The Netherlands Cancer Institute
- People needed
- 100
- Starts
- 2025-11-06
- Expected to finish
- 2030-07-01
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged 18 years or older
- Histologically confirmed adenocarcinoma of the breast
- Assumed clinical or pathological stage III (TNM) breast cancer
- Breast tumor must be:
- 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)
- Hormone receptor negative i.e. an estrogen receptor (ER) of <10% and progesterone receptor (PR) of <10%.; or in case of a histological grade III tumor an ER of <50% and a PR of <50%.
- Patients are planned to receive the complete standard of care in the Netherlands; neo-adjuvant chemotherapy according to local practise
- Participating patients have to be able to use a mobile phone, tablet, laptop and/or computer and understand the Dutch language
You may not qualify if…
- 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.
Where it is running
- Maastricht University Medical Center — Maastricht, Netherlands (enrolling)
- ErasmusMC — Rotterdam, Netherlands (enrolling)
- The Netherlands Cancer Institute — Amsterdam, Netherlands (enrolling)
- Medical spectrum Twente — Enschede, Overijssel, Netherlands (enrolling)
- UMCG — Groningen, Netherlands (enrolling)
- Amphia — Breda, Netherlands
- Amsterdam University Medical Center — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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