Status:
RECRUITING
TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 st...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06931769
Start Date
November 6 2025
End Date
July 1 2030
Last Update
November 26 2025
Active Locations (6)
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1
Medical spectrum Twente
Enschede, Overijssel, Netherlands, 7500 KA
2
Amsterdam University Medical Center
Amsterdam, Netherlands
3
The Netherlands Cancer Institute
Amsterdam, Netherlands
4
UMCG
Groningen, Netherlands, 9713 GZ