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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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 seven 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

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.

Study details
    Breast Cancer

NCT06931769

The Netherlands Cancer Institute

1 February 2026

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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