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

April 17, 2025 updated by: The Netherlands Cancer Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marleen Kok, MD
  • Phone Number: +31205129111
  • Email: m.kok@nki.nl

Study Contact Backup

  • Name: Rianne Rolfes, MD
  • Phone Number: +31205129111
  • Email: r.rolfes@nki.nl

Study Locations

  • Netherlands
      • Alkmaar, Netherlands
        • Not yet recruiting
        • Noordwest Ziekenhuisgroep
        • Contact:
          • S Vrijaldenhoven, MD
      • Almere, Netherlands
        • Not yet recruiting
        • Flevoziekenhuis
        • Contact:
          • S A.L Bartels, MD
        • Contact:
          • S A.L. Bartels, MD
      • Amersfoort, Netherlands
        • Recruiting
        • Meander Medisch Centrum
        • Contact:
          • J M Baas, MD
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Antoni van Leeuwenhoek
        • Contact:
          • Marleen Kok, MD
          • Phone Number: 9111 +3120512
          • Email: m.kok@nki.nl
        • Contact:
        • Contact:
          • Marleen Kok, MD
      • Amsterdam, Netherlands
        • Recruiting
        • Onze Lieve Vrouwe Gasthuis (OLVG)
        • Contact:
          • B Flameling, MD
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate
        • Contact:
          • K Beelen, MD
      • Breda, Netherlands
        • Recruiting
        • Amphia Ziekenhuis
        • Contact:
          • J Heijns, MD
      • Den Haag, Netherlands
        • Recruiting
        • Haaglanden Medisch Centrum
        • Contact:
          • R. Oosterkamp, MD, PhD
      • Deventer, Netherlands
        • Recruiting
        • Deventer Ziekenhuis
        • Contact:
          • L. Kessels, MD, PhD
      • Ede, Netherlands
        • Recruiting
        • Ziekenhuis Gelderse Vallei
        • Contact:
          • M Verstappen, MD
      • Eindhoven, Netherlands
        • Recruiting
        • Catharina Ziekenhuis
        • Contact:
          • R-J Schipper, MD
      • Eindhoven, Netherlands
        • Recruiting
        • Jeroen Bosch ziekenhuis
        • Contact:
          • J Tol, MD
      • Harderwijk, Netherlands
        • Recruiting
        • St. Jansdal
        • Contact:
          • J A Ropela, MD
      • Hengelo, Netherlands
        • Recruiting
        • Ziekenhuisgroep Twente
        • Contact:
          • E Siemerink, MD
      • Hilversum, Netherlands
        • Recruiting
        • Tergooi Ziekenhuizen
        • Contact:
          • A Willemsen, MD
      • Hoofddorp, Netherlands
        • Recruiting
        • Spaarne Gasthuis
        • Contact:
          • B de Valk, MD
      • Hoorn, Netherlands
        • Not yet recruiting
        • Dijklander ziekenhuis
        • Contact:
          • M M Vleugel, MD
      • Leeuwarden, Netherlands, 8934 AD
        • Not yet recruiting
        • MCL
        • Contact:
          • L Hamming, MD
      • Leiden, Netherlands
        • Not yet recruiting
        • LUMC
        • Contact:
          • J Kroep, MD
      • Maastricht, Netherlands
        • Not yet recruiting
        • MUMC
        • Contact:
          • M de Boer, MD
      • NIjmegen, Netherlands, 6225GA
        • Not yet recruiting
        • Radboud UMC
        • Contact:
          • E Kuip, MD
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Ziekenhuis
        • Contact:
          • M J Agterof, MD
      • Rotterdam, Netherlands, 3015CE
        • Not yet recruiting
        • Erasmus Medical Center Cancer Institute
        • Contact:
          • A Jager, MD
      • Schiedam, Netherlands
        • Recruiting
        • Franciscus Gasthuis & Vlietland
        • Contact:
          • J.M. Zuetenhorst, dr.
      • Venlo, Netherlands
        • Not yet recruiting
        • VieCuri Medisch Centrum voor Noord-Limburg
        • Contact:
          • E Boon, MD
      • Zwolle, Netherlands
        • Recruiting
        • Isala
        • Contact:
          • A Honkoop, MD
    • Limburg
      • Sittard-Geleen, Limburg, Netherlands, 6162 BG
        • Not yet recruiting
        • Zuyderland Medisch Centrum
        • Contact:
          • F van den Berkmortel, MD
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7500 KA
        • Recruiting
        • Medical Spectrum Twente
        • Contact:
          • M Wymenga, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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)

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Optimisation cohort
patients will be treated with surgery and adjuvant radiotherapy following local/national guidelines, while chemotherapy will be omitted
Other: No adjuvant chemotherapy
no adjuvant chemotherapy
Control cohort
patients will be treated with surgery, adjuvant radiotherapy and adjuvant chemotherapy following local/national guidelines
Drug: Adjuvant chemotherapy
adjuvant chemotherapy according to local/ national guidelines
Other Names:
  • according to local/ national guidelines

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population
Time Frame: up to 96 months after inclusion of the last patient
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Invasive disease-free survival (IDFS) - control cohort
Time Frame: up to 96 months after inclusion of the last patient
Number of patients with breast tumor recurrence or death in the control cohort
up to 96 months after inclusion of the last patient
disease recurrence free survival (DRFS) - control cohort
Time Frame: up to 96 months after inclusion of the last patient
time between inclusion and first distant recurrence or death from any cause in the control cohort
up to 96 months after inclusion of the last patient
Recurrence-free survival (RFS) - control cohort
Time Frame: up to 96 months after inclusion of the last patient
time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the control cohort;
up to 96 months after inclusion of the last patient
Overal Survival (OS) - control cohort
Time Frame: up to 96 months after inclusion of the last patient
time between inclusion and death from any cause in the control cohort;
up to 96 months after inclusion of the last patient
Fear of recurrence
Time Frame: up to 2 years after inclusion
Assessed with questionnaires to determine the difference in optimisation and control group
up to 2 years after inclusion
Cost effectiveness measured by quality-adjusted-life years (QALYs)
Time Frame: up to 2 years after inclusion
Measured per Quality-Adjusted Life Years (QALYs)
up to 2 years after inclusion
Cost effectiveness measured per incremental cost-effectiveness ratio (ICER)
Time Frame: up to 2 years after inclusion
Measured per incremental cost-effectiveness ratio (ICER)
up to 2 years after inclusion
Disease recurrence Free Interval (DRFI) - optimalisation cohort intention to treat population
Time Frame: up to 96 months after inclusion of the last patient
Number of patients with distant recurrence or death in intention to treat population of the optimisation cohort
up to 96 months after inclusion of the last patient
Disease recurrence Free Interval (DRFI) - control cohort
Time Frame: up to 96 months after inclusion of the last patient
Number of patients with distant recurrence or death in control cohort
up to 96 months after inclusion of the last patient
Invasive disease-free survival (IDFS) - optimalisation cohort per-protocol population
Time Frame: up to 96 months after inclusion of the last patient
Number of patients with breast tumor recurrence or death in the per-protocol population of the optimisation cohort
up to 96 months after inclusion of the last patient
Invasive disease-free survival (IDFS) - optimalisation cohort intention-to-treat population
Time Frame: up to 96 months after inclusion of the last patient
Number of patients with breast tumor recurrence or death in the the intention-to-treat population of the optimisation cohort
up to 96 months after inclusion of the last patient
disease recurrence free survival (DRFS) - optimalisation cohort per-protocol population
Time Frame: up to 96 months after inclusion of the last patient
time between inclusion and first distant recurrence or death from any cause in the per-protocol population of the optimisation cohort
up to 96 months after inclusion of the last patient
disease recurrence free survival (DRFS) - optimalisation cohort the intention-to-treat population
Time Frame: up to 96 months after inclusion of the last patient
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
up to 96 months after inclusion of the last patient
Recurrence-free survival (RFS) - optimalisation cohort per-protocol population
Time Frame: up to 96 months after inclusion of the last patient
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;
up to 96 months after inclusion of the last patient
Recurrence-free survival (RFS) - optimalisation cohort the intention-to-treat population
Time Frame: up to 96 months after inclusion of the last patient
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;
up to 96 months after inclusion of the last patient
Overal Survival (OS) - optimalisation cohort per-protocol population
Time Frame: up to 96 months after inclusion of the last patient
time between inclusion and death from any cause in the per-protocol population of the optimisation cohort;
up to 96 months after inclusion of the last patient
Overal Survival (OS) - optimalisation cohort intention-to-treat population
Time Frame: up to 96 months after inclusion of the last patient
time between inclusion and death from any cause in the the intention-to-treat population of the optimisation cohort;
up to 96 months after inclusion of the last patient
Health related Quality of Life (HRQoL) - (European Organisation on Research and Treatment of Cancer) EORTC questionnaire QLQ-C30
Time Frame: up to 2 years after inclusion
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.
up to 2 years after inclusion
Health related Quality of Life (HRQoL) - (European Organisation on Research and Treatment of Cancer) EORTC questionnaire QLQ-BR45
Time Frame: up to 2 years after inclusion
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.
up to 2 years after inclusion
Worries about health
Time Frame: up to 2 years after inclusion
Assessed with questionnaires to determine the difference in optimisation and control group. A higher score indicates a higher symptom burden.
up to 2 years after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Netherlands Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maarten van de Weijden Foundation
AVL Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marleen Kok, MD, Antoni van Leeuwenhoek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M24OTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no IPD plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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