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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-06

Study Completion Date

2030-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination Chemotherapy in Treating Women With Breast Cancer

NCT00003519

Breast Cancer

COMPLETED PHASE3

Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

NCT00136539

Breast Cancer

COMPLETED PHASE2

Systemic Therapy With or Without Upfront Surgery in Metastatic Breast Cancer

NCT01392586

Metastatic Breast Cancer

TERMINATED PHASE3

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

NCT05629585

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3

CTC Changes and Efficacy of Neoadjuvant Chemotherapy for Triple-negative Breast Cancer

NCT04059003

Breast Neoplasms

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No