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

Last updated: November 21, 2025
Sponsor: The Netherlands Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT06931769
M24TAO
  • Ages > 18
  • All Genders

Study 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 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 Criteria

Inclusion

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 atimmunohistochemistry and negative at in situ hybridization (ISH, CISH or FISH)

  • Hormone receptor negative i.e. an estrogen receptor (ER) of <10% andprogesterone receptor (PR) of <10%.; or in case of a histological grade IIItumor 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/orcomputer and understand the Dutch language

Exclusion

Exclusion Criteria:

  • Evidence of distant metastases. Staging examinations should have been performedaccording to Dutch national guidelines.

  • Patients who are only treated systemically in the adjuvant setting

  • Participation in another clinical study with an treatment intervention during thecourse of this study.

Study Design

Total Participants: 100
Study Start date:
November 06, 2025
Estimated Completion Date:
July 01, 2030

Connect with a study center

  • Medical spectrum Twente

    Enschede 2756071, Overijssel 2748838 7500 KA
    Netherlands

    Active - Recruiting

  • The Netherlands Cancer Institute

    Amsterdam,
    Netherlands

    Site Not Available

  • Amsterdam University Medical Center

    Amsterdam 2759794,
    Netherlands

    Site Not Available

  • The Netherlands Cancer Institute

    Amsterdam 2759794,
    Netherlands

    Active - Recruiting

  • UMCG

    Groningen 2755251, 9713 GZ
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center

    Maastricht 2751283,
    Netherlands

    Active - Recruiting

  • ErasmusMC

    Rotterdam 2747891,
    Netherlands

    Site Not Available

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