Optimizing treatment for low stage triple-negative breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical spectrum Twente
  Enschede, Overijssel, Netherlands Recruiting
• Meander Medisch Centrum
  Amersfoort, Netherlands Recruiting
• Antoni van Leeuwenhoek
  Amsterdam, Netherlands Recruiting
• Onze Lieve Vrouwe Gasthuis (OLVG)
  Amsterdam, Netherlands Recruiting
• Rijnstate
  Arnhem, Netherlands Recruiting
• Amphia ziekenhuis
  Breda, Netherlands Recruiting

Study contacts

• Principal investigator: Marleen Kok, MD — Antoni van Leeuwenhoek
• Study coordinator: Marleen Kok, MD
• Email: m.kok@nki.nl
• Phone: +31205129111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial tests a 12-week, anthracycline-free neoadjuvant regimen of carboplatin, paclitaxel, and pembrolizumab in early-stage TNBC with high TILs to see if surgery outcomes are as good as historical regimens.

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• BL-B01D1 plus PD-1 therapy vs nab-paclitaxel plus PD-1 therapy in untreated PD-L1-positive locally advanced or metastatic TNBC

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• Isunakinra Plus Pembrolizumab Neoadjuvant Therapy for TNBC

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• Self-amplifying RNA vaccine ITI-5000 for stage 2-3 TNBC (two-part study)

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• Capecitabine for MRD-positive, resected ER+/HER2-negative breast cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.