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NCT06931769 | NOT YET RECRUITING | Breast Cancer

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

The Netherlands Cancer Institute

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 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.

Condition or disease

Breast Cancer

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
Actual Study Start Date : 2025-06-05
Estimated Primary Completion Date : 2029-07-01
Estimated Study Completion Date : 2030-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer

Location Details

NCT06931769

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Netherlands,

The Netherlands Cancer Institute

Amsterdam, Netherlands,