Actively Recruiting
OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes
Led by The Netherlands Cancer Institute · Updated on 2025-04-23
490
Participants Needed
28
Research Sites
491 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
M
Maarten van de Weijden Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male patients
- Age 18 years or older
- Written informed consent given
- Diagnosis of triple-negative breast cancer (TNBC) confirmed by biopsy and surgical specimen
- Pathological stage I TNBC with tumor size 2 cm or less and no lymph node metastases
- No signs of cancer spread on imaging tests including PET/CT or CT scans
- High stromal tumor-infiltrating lymphocytes score (at least 50% or 75% depending on age) confirmed on tissue samples
- Completed curative breast surgery including lymph node staging
- No breast cancer recurrence after surgery
- Eligible for radiotherapy if needed
You will not qualify if you...
- Previous or ongoing invasive or non-invasive breast cancer
- Multifocal, multicentric, or bilateral breast cancer at screening
- Received neoadjuvant systemic therapy
- Presence of lymphovascular invasion in biopsy or surgical specimen
- Other invasive cancers within 5 years except certain treated skin, cervical, or prostate cancers
- Uncontrolled severe illness or medical condition
- Any psychological, family, social, or geographic issues preventing study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Zuyderland Medisch Centrum
Sittard-Geleen, Limburg, Netherlands, 6162 BG
Not Yet Recruiting
2
Medical spectrum Twente
Enschede, Overijssel, Netherlands, 7500 KA
Actively Recruiting
3
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Not Yet Recruiting
4
Flevoziekenhuis
Almere Stad, Netherlands
Not Yet Recruiting
5
Meander Medisch Centrum
Amersfoort, Netherlands
Actively Recruiting
6
Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
7
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands
Actively Recruiting
8
Rijnstate
Arnhem, Netherlands
Actively Recruiting
9
Amphia ziekenhuis
Breda, Netherlands
Actively Recruiting
10
Deventer Ziekenhuis
Deventer, Netherlands
Actively Recruiting
11
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Actively Recruiting
12
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
13
Jeroen Bosch ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
14
St. Jansdal
Harderwijk, Netherlands
Actively Recruiting
15
Ziekenhuisgroep Twente
Hengelo, Netherlands
Actively Recruiting
16
Tergooi ziekenhuizen
Hilversum, Netherlands
Actively Recruiting
17
Spaarne Gasthuis
Hoofddorp, Netherlands
Actively Recruiting
18
Dijklander ziekenhuis
Hoorn, Netherlands
Not Yet Recruiting
19
MCL
Leeuwarden, Netherlands, 8934 AD
Not Yet Recruiting
20
LUMC
Leiden, Netherlands
Not Yet Recruiting
21
MUMC
Maastricht, Netherlands
Not Yet Recruiting
22
St. Antonius ziekenhuis
Nieuwegein, Netherlands
Actively Recruiting
23
Radboud UMC
Nijmegen, Netherlands, 6225GA
Not Yet Recruiting
24
Erasmus Medical Center Cancer Institute
Rotterdam, Netherlands, 3015CE
Not Yet Recruiting
25
Franciscus Gasthuis & Vlietland
Schiedam, Netherlands
Actively Recruiting
26
Haaglanden Medisch Centrum
The Hague, Netherlands
Actively Recruiting
27
VieCuri Medisch Centrum voor Noord-Limburg
Venlo, Netherlands
Not Yet Recruiting
28
Isala
Zwolle, Netherlands
Actively Recruiting
Research Team
M
Marleen Kok, MD
CONTACT
R
Rianne Rolfes, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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