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

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam University Medical Center
NOT_YET_RECRUITING
Amsterdam
The Netherlands Cancer Institute
RECRUITING
Amsterdam
Medical spectrum Twente
RECRUITING
Enschede
UMCG
RECRUITING
Groningen
Maastricht University Medical Center
RECRUITING
Maastricht
ErasmusMC
NOT_YET_RECRUITING
Rotterdam
Contact Information
Primary
Pien Debets, Study coordinator
p.debets@nki.nl
0205129111
Backup
Ingrid Mandjes, Clinical Projects Manager
Time Frame
Start Date: 2025-11-06
Estimated Completion Date: 2030-07-01
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: The Netherlands Cancer Institute
Collaborators: Dutch Cancer Society

This content was sourced from clinicaltrials.gov