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OPTImaL

  • Submitted

BOOG 2024-03

General Information

BOOG number

BOOG 2024-03

Nickname

OPTImaL

Status

  • Submitted
Date: 04/06/2024

Other study number

NKI-AVL: M24OTI

Full title

Optimisation of treatment for patients with low stage triple-negative breast cancer with high sTIL

Indication

  • Adjuvant, Observational

Subindication

TNBC

Description

Optimisation of treatment in low stage TNBC with high sTIL

Target sample size

245

Contact

Sponsor

NKI-AVL

Principal Investigator(s)

Dr. Marleen. Kok (PI), medisch oncoloog NKI-AVL

Dr. Roberto Salgado (co-PI), patholoog UZ Middelheim

Dr. Hugo Horlings (co-PI), patholoog NKI-AVL

Study manager

BOOG Study Center:

Dr. A. Elise van Leeuwen-Stok (CSM)

Sandra A.W.M. Veldt-Verkuijlen (PM)

T: 088 234 6730

E: info@boogstudycenter.nl

 

 

Study coordinator

Rianne Rolfes, arts-onderzoeker NKI-AVL

T: 020 512 3436

E: optimal@nki.nl

Central datamanagement and randomization

NKI-AVL

Yvonne Wijnands of  Annelies Hiemstra

E: y.wijnands@nki.nl / a.hiemstra@nki.nl

Funding

Maarten van der Weijden Foundation

KWF Langetermijn programma Biomarkers

Design

This study is an international, open-label, pragmatic, patient-preference trial for patients with stage I triple-negative breast cancer (TNBC) and a high sTIL (stromal tumor-infiltrating lymphocytes) score (defined as ≥50% for patients ≥40 years; ≥75% for patients <40 years) to evaluate whether adjuvant chemotherapy can be safely omitted.

Participating sites

Netherlands:

 

Other Countries:

Objectives

To assess whether adjuvant chemotherapy can be safely omitted in patients with pathological
stage I (pT1a/b/cN0) TNBC and a high sTIL score (defined as =50%; =75% for age <40 years)
with regards to the incidence of distant recurrence or death from breast cancer (optimisation
cohort).

 

Endpoints

Main endpoint:
Distant recurrence-free interval in the optimisation cohort (group without adjuvant chemotherapy).

 

Secondary  endpoints:

Quality of life, fear of recurrence and worries about health, cost-effectiveness and other survival endpoints in the optimisation and control cohort (distant recurrence-free interval, invasive-disease free survival, distant relapse-free survival, recurrence-free interval, overall survival).

Eligibility Criteria

Main inclusion criteria:

  • Female or male patients (≥ 18 years).
  • 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) (27):
    • 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 preoperative imaging examinations (performed following local/national guidelines, but must include an 18Ffluorodeoxyglucose
    positron emission tomography/computed tomography [18F-FDGPET/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; 18FFDG-PET/CT mandatory in the Netherlands]).
  • TIL score of =50% (=75% for patients <40 years) 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.
  • 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).

 

Main exclusion criteria:

  • Prior disease history of breast cancer, or ongoing treatment for 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.

Regulatory Information

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