Towards optimal neoadjuvant and adjuvant systemic therapy for stage III triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical spectrum Twente
  Enschede, Overijssel, Netherlands Recruiting
• The Netherlands Cancer Institute
  Amsterdam, Netherlands Recruiting
• Amphia
  Breda, Netherlands 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.