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Breast Cancer Stage IOPTImaLNCT06476119

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

An observational study of Breast Cancer Stage I and Triple Negative Breast Cancer (TNBC), run by The Netherlands Cancer Institute at 28 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Adjuvant chemotherapy and No adjuvant chemotherapy
How many people
490 participants
Where
28 sitesNetherlands
Study dates
15 Apr 2025to 15 Sep 2034
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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)

Who may be able to join

  • 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);
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  • 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).

Who cannot join

  • 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;
  • Other invasive malignancy within 5 years prior to inclusion, with the exception of ade-quately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤6 prostate cancer;
  • 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.

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marleen Kok, MD contact

+31205129111

m.kok@nki.nl

Rianne Rolfes, MD contact

+31205129111

r.rolfes@nki.nl

28 sites in 1 country

Netherlands28 sites, 28 recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar

    S Vrijaldenhoven, MD

    Not yet recruiting

  • Flevoziekenhuis

    Almere Stad

    S A.L Bartels, MD

    S A.L. Bartels, MD

    Not yet recruiting

  • Meander Medisch Centrum

    Amersfoort

    J M Baas, MD

    Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

    Marleen Kok, MD, +3120512 ext. 9111, m.kok@nki.nl

    Ingrid AM Mandjes, MSc, +3120512 ext. 9111, i.mandjes@nki.nl

    Recruiting

  • Onze Lieve Vrouwe Gasthuis (OLVG)

    Amsterdam

    B Flameling, MD

    Recruiting

  • Rijnstate

    Arnhem

    K Beelen, MD

    Recruiting

  • Amphia ziekenhuis

    Breda

    J Heijns, MD

    Recruiting

  • Deventer Ziekenhuis

    Deventer

    L. Kessels, MD, PhD

    Recruiting

  • Ziekenhuis Gelderse Vallei

    Ede

    M Verstappen, MD

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven

    R-J Schipper, MD

    Recruiting

  • Jeroen Bosch ziekenhuis

    Eindhoven

    J Tol, MD

    Recruiting

  • Medical spectrum Twente

    Enschede, Overijssel, 7500 KA

    M Wymenga, MD

    Recruiting

  • St. Jansdal

    Harderwijk

    J A Ropela, MD

    Recruiting

  • Ziekenhuisgroep Twente

    Hengelo

    E Siemerink, MD

    Recruiting

  • Tergooi ziekenhuizen

    Hilversum

    A Willemsen, MD

    Recruiting

  • Spaarne Gasthuis

    Hoofddorp

    B de Valk, MD

    Recruiting

  • Dijklander ziekenhuis

    Hoorn

    M M Vleugel, MD

    Not yet recruiting

  • MCL

    Leeuwarden, 8934 AD

    L Hamming, MD

    Not yet recruiting

  • LUMC

    Leiden

    J Kroep, MD

    Not yet recruiting

  • MUMC

    Maastricht

    M de Boer, MD

    Not yet recruiting

  • St. Antonius ziekenhuis

    Nieuwegein

    M J Agterof, MD

    Recruiting

  • Radboud UMC

    Nijmegen, 6225GA

    E Kuip, MD

    Not yet recruiting

  • Erasmus Medical Center Cancer Institute

    Rotterdam, 3015CE

    A Jager, MD

    Not yet recruiting

  • Franciscus Gasthuis & Vlietland

    Schiedam

    J.M. Zuetenhorst, dr.

    Recruiting

  • Zuyderland Medisch Centrum

    Sittard-Geleen, Limburg, 6162 BG

    F van den Berkmortel, MD

    Not yet recruiting

  • Haaglanden Medisch Centrum

    The Hague

    R. Oosterkamp, MD, PhD

    Recruiting

  • VieCuri Medisch Centrum voor Noord-Limburg

    Venlo

    E Boon, MD

    Not yet recruiting

  • Isala

    Zwolle

    A Honkoop, MD

    Recruiting

Other trials in Netherlands

About this study

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.

Being tested
Adjuvant chemotherapy, No adjuvant chemotherapy
Keywords
High (stromal Tumor-Infiltrating-Lymphocytes) sTIL score
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant chemotherapyDrug

    Also called according to local/ national guidelines

    adjuvant chemotherapy according to local/ national guidelines

  • No adjuvant chemotherapyOther

    no adjuvant chemotherapy

Study groups in NCT06476119
Study groupRoleWhat they receive
Optimisation cohortpatients will be treated with surgery and adjuvant radiotherapy following local/national guidelines, while chemotherapy will be omitted
Receives: Other: No adjuvant chemotherapy
Control cohortpatients will be treated with surgery, adjuvant radiotherapy and adjuvant chemotherapy following local/national guidelines
Receives: Drug: Adjuvant chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 96 months after inclusion of the last patient

Secondary outcomes (20)

  1. Disease recurrence Free Interval (DRFI) - optimalisation cohort intention to treat population

    Number of patients with distant recurrence or death in intention to treat population of the optimisation cohort

    Measured: up to 96 months after inclusion of the last patient

  2. Disease recurrence Free Interval (DRFI) - control cohort

    Number of patients with distant recurrence or death in control cohort

    Measured: up to 96 months after inclusion of the last patient

  3. Invasive disease-free survival (IDFS) - optimalisation cohort per-protocol population

    Number of patients with breast tumor recurrence or death in the per-protocol population of the optimisation cohort

    Measured: up to 96 months after inclusion of the last patient

  4. Invasive disease-free survival (IDFS) - optimalisation cohort intention-to-treat population

    Number of patients with breast tumor recurrence or death in the the intention-to-treat population of the optimisation cohort

    Measured: up to 96 months after inclusion of the last patient

  5. Invasive disease-free survival (IDFS) - control cohort

    Number of patients with breast tumor recurrence or death in the control cohort

    Measured: up to 96 months after inclusion of the last patient

  6. disease recurrence free survival (DRFS) - optimalisation cohort per-protocol population

    time between inclusion and first distant recurrence or death from any cause in the per-protocol population of the optimisation cohort

    Measured: up to 96 months after inclusion of the last patient

  7. disease recurrence free survival (DRFS) - optimalisation cohort the intention-to-treat population

    time between inclusion and first distant recurrence or death from any cause in the intention-to-treat population of the optimisation cohort population of the optimisation cohort

    Measured: up to 96 months after inclusion of the last patient

  8. disease recurrence free survival (DRFS) - control cohort

    time between inclusion and first distant recurrence or death from any cause in the control cohort

    Measured: up to 96 months after inclusion of the last patient

  9. Recurrence-free survival (RFS) - optimalisation cohort per-protocol population

    time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the per-protocol population of the optimisation cohort;

    Measured: up to 96 months after inclusion of the last patient

  10. Recurrence-free survival (RFS) - optimalisation cohort the intention-to-treat population

    time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the the intention-to-treat population of the optimisation cohort;

    Measured: up to 96 months after inclusion of the last patient

  11. Recurrence-free survival (RFS) - control cohort

    time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the control cohort;

    Measured: up to 96 months after inclusion of the last patient

  12. Overal Survival (OS) - optimalisation cohort per-protocol population

    time between inclusion and death from any cause in the per-protocol population of the optimisation cohort;

    Measured: up to 96 months after inclusion of the last patient

  13. Overal Survival (OS) - optimalisation cohort intention-to-treat population

    time between inclusion and death from any cause in the the intention-to-treat population of the optimisation cohort;

    Measured: up to 96 months after inclusion of the last patient

  14. Overal Survival (OS) - control cohort

    time between inclusion and death from any cause in the control cohort;

    Measured: up to 96 months after inclusion of the last patient

  15. Health related Quality of Life (HRQoL) - (European Organisation on Research and Treatment of Cancer) EORTC questionnaire QLQ-C30

    Difference in QoL assessed with the EORTC QLQ-C30 questionnaires between the optimisation and the control group. A higher score indicates a higher symptom burden.

    Measured: up to 2 years after inclusion

  16. Health related Quality of Life (HRQoL) - (European Organisation on Research and Treatment of Cancer) EORTC questionnaire QLQ-BR45

    Difference in QoL assessed with the EORTC QLQ-BR45 questionnaires between the optimisation and the control group. A higher score indicates a higher symptom burden.

    Measured: up to 2 years after inclusion

  17. Fear of recurrence

    Assessed with questionnaires to determine the difference in optimisation and control group

    Measured: up to 2 years after inclusion

  18. Worries about health

    Assessed with questionnaires to determine the difference in optimisation and control group. A higher score indicates a higher symptom burden.

    Measured: up to 2 years after inclusion

  19. Cost effectiveness measured by quality-adjusted-life years (QALYs)

    Measured per Quality-Adjusted Life Years (QALYs)

    Measured: up to 2 years after inclusion

  20. Cost effectiveness measured per incremental cost-effectiveness ratio (ICER)

    Measured per incremental cost-effectiveness ratio (ICER)

    Measured: up to 2 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start15 Apr 2025
  3. Primary completion15 Sep 2032 (estimated)
  4. Study completion15 Sep 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476119
Sponsor's protocol ID
M24OTI
Acronym
OPTImaL
Status last verified
Apr 2025
First submitted
7 Jun 2024
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no IPD plan

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Stage I and Triple Negative Breast Cancer (TNBC), run by The Netherlands Cancer Institute at 28 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marleen Kok, MD (+31205129111, m.kok@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population (time frame: up to 96 months after inclusion of the last patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06476119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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