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Optimizing treatment for low stage triple-negative breast cancer patients

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

Observational The Netherlands Cancer Institute · NCT06476119

This study is testing if patients with early-stage triple-negative breast cancer can skip chemotherapy after surgery and radiation if they have certain positive signs, to see how it affects their safety and quality of life.

Quick facts

Study typeObservational
Enrollment490 (estimated)
Ages18 Years and up
SexAll
SponsorThe Netherlands Cancer Institute Academic / other
Drugs / interventionschemotherapy, radiation
Locations28 sites (Sittard-Geleen, Limburg and 27 other locations)
Trial IDNCT06476119 on ClinicalTrials.gov

What this trial studies

This study investigates whether patients with low stage triple-negative breast cancer (TNBC) can safely omit chemotherapy after surgery and radiation if they exhibit certain favorable features, particularly a high stromal tumor-infiltrating lymphocytes (sTIL) score. Participants will consult with their treating physician to decide on the use of adjuvant chemotherapy. The study aims to assess not only the safety of omitting chemotherapy but also its impact on the quality of life for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage I triple-negative breast cancer and a high sTIL score.

Not a fit: Patients with more advanced stages of breast cancer or those with metastases will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the need for chemotherapy in certain patients, potentially improving their quality of life.

How similar studies have performed: Other studies have explored similar approaches in breast cancer treatment, indicating potential for success, though this specific methodology may be novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Sittard-Geleen, Limburg and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Cancer Stage ITriple Negative Breast CancerHigh sTIL score
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.