Clinical trial · Observational
TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 1.
- timeFrame
- Up to 36 months after surgery
- description
- The HRQoL will be assessed through the following questionnaire: • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ C30)
- measure
- To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 2.
- timeFrame
- Up to 36 months after surgery
- description
- The HRQoL will be assessed through the following questionnaire: • European Organization for Research and Treatment of Breast Cancer specific Quality of Life Questionnaire (EORTC QLQ BR23)
- measure
- To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 3.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available