OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes
OPTImaL
1 other identifier
observational
490
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 26, 2024
CompletedStudy Start
First participant enrolled
April 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2034
April 23, 2025
April 1, 2025
7.4 years
June 7, 2024
April 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population
Number of patients with distant recurrence or death in per-protocol population of the optimisation cohort
up to 96 months after inclusion of the last patient
Secondary Outcomes (20)
Disease recurrence Free Interval (DRFI) - optimalisation cohort intention to treat population
up to 96 months after inclusion of the last patient
Disease recurrence Free Interval (DRFI) - control cohort
up to 96 months after inclusion of the last patient
Invasive disease-free survival (IDFS) - optimalisation cohort per-protocol population
up to 96 months after inclusion of the last patient
Invasive disease-free survival (IDFS) - optimalisation cohort intention-to-treat population
up to 96 months after inclusion of the last patient
Invasive disease-free survival (IDFS) - control cohort
up to 96 months after inclusion of the last patient
- +15 more secondary outcomes
Study Arms (2)
Optimisation cohort
patients will be treated with surgery and adjuvant radiotherapy following local/national guidelines, while chemotherapy will be omitted
Control cohort
patients will be treated with surgery, adjuvant radiotherapy and adjuvant chemotherapy following local/national guidelines
Interventions
adjuvant chemotherapy according to local/ national guidelines
Eligibility Criteria
patients with pathological stage I TNBC (pT1a/b/cN0) and a high sTIL score (defined as ≥50% for patients ≥40 years; ≥75% for patients \<40 years)
You may qualify if:
- Female or male patients;
- \>=18 years;
- Written informed consent;
- TNBC (defined as: invasive carcinoma; ER/PR expression 0-9%; Human Epidermal Growth Factor Receptor 2 \[HER2\] negative \[0, 1+ or 2+ on immunohistochemistry, without HER2 amplification on in-situ hybridization\]) on the diagnostic biopsy and the surgical specimen;
- Pathological stage I TNBC (according to the TNM staging 8th edition):
- pT1a/b/c (≤2 cm), confirmed by an invasive component of ≤2 cm on the surgical specimen (microinvasive disease \[pT1mi, ≤1 mm) is not allowed);
- pN0, confirmed by absence of malignant cells in the sentinel lymph node or any other lymph node after surgery (isolated tumor cells \[N0(i+)\] are not allowed);
- No evidence of nodal or distant metastases (cN0M0) on pre and/or postoperative imaging examinations (performed following local/national guidelines, but must include an 18F-fluorodeoxyglucose positron emission tomography/computed tomography \[18F-FDG-PET/CT, at least from skull base to upper legs\] or computed tomography \[CT\] of neck/chest/abdomen/pelvis \[CT only if 18F-FDG-PET/CT would not be available; 18F-FDG-PET/CT mandatory in the Netherlands\]);
- sTIL score of ≥50% for patients ≥40 years at the time of TNBC diagnosis and ≥75% for patients \<40 years at the time of TNBC diagnosis on an H\&E FFPE tissue slide on the surgical specimen, according to International Immuno-Oncology Biomarker Working Group on Breast Cancer (formerly International TILs Working Group) guidelines, by local and central review
- Has undergone curative breast surgery (breast-conserving surgery or mastectomy and surgical axillary staging \[including at least sentinel lymph node procedure\]);
- Absence of recurrence between curative breast surgery and expression of patient preference;
- Eligible for radiotherapy (if indicated).
You may not qualify if:
- Prior disease history of invasive and/or non-invasive breast cancer, or ongoing treatment for invasive and/or non-invasive breast cancer;
- Multifocal, multicentric or bilateral breast cancer at the time of screening;
- Administration of neoadjuvant systemic therapy;
- Presence of lymphovascular invasion on the diagnostic biopsy and/or the surgical specimen;
- Uncontrolled severe illness or medical condition;
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Netherlands Cancer Institutelead
- Maarten van de Weijden Foundationcollaborator
- AVL Foundationcollaborator
Study Sites (28)
Zuyderland Medisch Centrum
Sittard-Geleen, Limburg, 6162 BG, Netherlands
Medical spectrum Twente
Enschede, Overijssel, 7500 KA, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Antoni van Leeuwenhoek
Amsterdam, 1066 CX, 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, 8934 AD, Netherlands
LUMC
Leiden, Netherlands
MUMC
Maastricht, Netherlands
St. Antonius ziekenhuis
Nieuwegein, Netherlands
Radboud UMC
Nijmegen, 6225GA, Netherlands
Erasmus Medical Center Cancer Institute
Rotterdam, 3015CE, Netherlands
Franciscus Gasthuis & Vlietland
Schiedam, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
VieCuri Medisch Centrum voor Noord-Limburg
Venlo, Netherlands
Isala
Zwolle, Netherlands
Biospecimen
ctDNA samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marleen Kok, MD
Antoni van Leeuwenhoek
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2024
First Posted
June 26, 2024
Study Start
April 15, 2025
Primary Completion (Estimated)
September 15, 2032
Study Completion (Estimated)
September 15, 2034
Last Updated
April 23, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
no IPD plan