Towards optimal neoadjuvant and adjuvant systemic therapy for stage III triple-negative breast cancer
TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
This project will follow people with stage III triple-negative breast cancer who are starting standard (neo)adjuvant chemotherapy to see how treatments affect outcomes and quality of life and, if they agree, to track tumor DNA in blood over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Enschede, Overijssel and 6 other locations) |
| Trial ID | NCT06931769 on ClinicalTrials.gov |
What this trial studies
This is a prospective, national, multicenter observational cohort of patients with clinical or pathological stage III triple-negative breast cancer receiving standard (neo)adjuvant systemic therapy in the Netherlands. Clinical, pathological, treatment, and follow-up data will be collected through Dutch databases, while patients complete cancer-specific and generic quality-of-life questionnaires at nine time points using a mobile application. For participants consenting to additional blood draws, two tubes will be collected at four predefined time points to measure dynamic circulating tumor DNA (ctDNA) and relate its course to clinical outcomes. No experimental treatments are given; all patients receive local standard-of-care chemotherapy according to Dutch practice.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed stage III triple-negative breast cancer who are planned to receive complete standard (neo)adjuvant chemotherapy in the Netherlands and can use Dutch-language digital devices are ideal candidates.
Not a fit: Patients with distant metastases, those not receiving standard (neo)adjuvant chemotherapy, or those unable or unwilling to complete the mobile questionnaires or blood sampling are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the project could identify ctDNA patterns and quality-of-life trends that predict relapse and inform more personalized follow-up and supportive care for patients with stage III TNBC.
How similar studies have performed: Previous observational cohorts and early clinical studies have shown that serial ctDNA can often predict relapse in early breast cancer, but routine clinical use is still emerging and not yet standard.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Enschede, Overijssel and 6 other locations
- Medical spectrum Twente — Enschede, Overijssel, Netherlands (Recruiting)
- Amsterdam University Medical Center — Amsterdam, Netherlands (Not_yet_recruiting)
- The Netherlands Cancer Institute — Amsterdam, Netherlands (Recruiting)
- Amphia — Breda, Netherlands (Not_yet_recruiting)
- Umcg — Groningen, Netherlands (Recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)
- ErasmusMC — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Pien Debets, Study coordinator
- Email: p.debets@nki.nl
- Phone: 0205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.