RecruitingNCT06476119

OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes


Sponsor

The Netherlands Cancer Institute

Enrollment

490 participants

Start Date

Apr 15, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment. In addition, the investigation looks at whether the omission of chemotherapy ensures a better quality of life. Participants decide, in consultation with their treating physician, whether they choose to be treated with adjuvant chemotherapy or not.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether close monitoring alone — without additional chemotherapy — is enough for people with a type of early-stage, highly immune-active triple-negative breast cancer (TNBC). TNBC is a breast cancer type that lacks three common receptors used by other treatments. In these early-stage tumors with high immune cell infiltration, some patients may not need additional treatment after surgery, and this trial aims to find out if that is safe. **You may be eligible if...** - You have stage I (small, early-stage) triple-negative breast cancer (TNBC) - Your tumor is 2 cm or smaller and has not spread to lymph nodes - Your tumor has a high proportion of immune cells (TILs ≥50% if age ≥40, or ≥75% if age <40) - You have already had curative breast surgery - You have had imaging confirming no cancer spread **You may NOT be eligible if...** - You have had prior breast cancer (invasive or non-invasive) - Your cancer is in multiple spots or in both breasts - You received chemotherapy before surgery (neoadjuvant therapy) - You have another active cancer within the past 5 years - You have uncontrolled serious illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdjuvant chemotherapy

adjuvant chemotherapy according to local/ national guidelines

OTHERNo adjuvant chemotherapy

no adjuvant chemotherapy


Locations(28)

Zuyderland Medisch Centrum

Sittard-Geleen, Limburg, Netherlands

Medical spectrum Twente

Enschede, Overijssel, Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Flevoziekenhuis

Almere Stad, Netherlands

Meander Medisch Centrum

Amersfoort, Netherlands

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, Netherlands

Rijnstate

Arnhem, Netherlands

Amphia ziekenhuis

Breda, Netherlands

Deventer Ziekenhuis

Deventer, Netherlands

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Jeroen Bosch ziekenhuis

Eindhoven, Netherlands

St. Jansdal

Harderwijk, Netherlands

Ziekenhuisgroep Twente

Hengelo, Netherlands

Tergooi ziekenhuizen

Hilversum, Netherlands

Spaarne Gasthuis

Hoofddorp, Netherlands

Dijklander ziekenhuis

Hoorn, Netherlands

MCL

Leeuwarden, Netherlands

LUMC

Leiden, Netherlands

MUMC

Maastricht, Netherlands

St. Antonius ziekenhuis

Nieuwegein, Netherlands

Radboud UMC

Nijmegen, Netherlands

Erasmus Medical Center Cancer Institute

Rotterdam, Netherlands

Franciscus Gasthuis & Vlietland

Schiedam, Netherlands

Haaglanden Medisch Centrum

The Hague, Netherlands

VieCuri Medisch Centrum voor Noord-Limburg

Venlo, Netherlands

Isala

Zwolle, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06476119


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