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

ClinicalTrials.gov ID

NCT06931769

Lead Sponsor

The Netherlands Cancer InstituteOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

May 13, 2026Actual

Start Date

Nov 6, 2025Actual

Primary Completion Date

Jul 1, 2029Estimated

Completion Date

Jul 1, 2030Estimated

Official Title

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

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 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.

• Breast Cancer

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

The Netherlands Cancer InstituteOTHER

Collaborators

Dutch Cancer SocietyOTHER

s.linn@nki.nl+3125129111

JHeijns@amphia.nl

a.jager@erasmusmc.nl

a.jager@erasmusmc.nl

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