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

Обзор

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.

Вмешательства

• Препарат Adjuvant chemotherapy
  adjuvant chemotherapy according to local/ national guidelines
• Другое No adjuvant chemotherapy
  no adjuvant chemotherapy

Первичные конечные точки

• Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population [Срок оценки: up to 96 months after inclusion of the last patient]

Вторичные конечные точки (12)

• Disease recurrence Free Interval (DRFI) - optimalisation cohort intention to treat population [Срок оценки: up to 96 months after inclusion of the last patient]
• Disease recurrence Free Interval (DRFI) - control cohort [Срок оценки: up to 96 months after inclusion of the last patient]
• Invasive disease-free survival (IDFS) - optimalisation cohort per-protocol population [Срок оценки: up to 96 months after inclusion of the last patient]
• Invasive disease-free survival (IDFS) - optimalisation cohort intention-to-treat population [Срок оценки: up to 96 months after inclusion of the last patient]
• Invasive disease-free survival (IDFS) - control cohort [Срок оценки: up to 96 months after inclusion of the last patient]
• disease recurrence free survival (DRFS) - optimalisation cohort per-protocol population [Срок оценки: up to 96 months after inclusion of the last patient]
• disease recurrence free survival (DRFS) - optimalisation cohort the intention-to-treat population [Срок оценки: up to 96 months after inclusion of the last patient]
• disease recurrence free survival (DRFS) - control cohort [Срок оценки: up to 96 months after inclusion of the last patient]
• Recurrence-free survival (RFS) - optimalisation cohort per-protocol population [Срок оценки: up to 96 months after inclusion of the last patient]
• Recurrence-free survival (RFS) - optimalisation cohort the intention-to-treat population [Срок оценки: up to 96 months after inclusion of the last patient]
• Recurrence-free survival (RFS) - control cohort [Срок оценки: up to 96 months after inclusion of the last patient]
• Overal Survival (OS) - optimalisation cohort per-protocol population [Срок оценки: up to 96 months after inclusion of the last patient]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 28 центров

• Zuyderland Medisch Centrum — Sittard-Geleen
• Medical spectrum Twente — Enschede
• Noordwest Ziekenhuisgroep — Alkmaar
• Flevoziekenhuis — Almere Stad
• Meander Medisch Centrum — Amersfoort
• Antoni van Leeuwenhoek — Amsterdam
• Onze Lieve Vrouwe Gasthuis (OLVG) — Amsterdam
• Rijnstate — Arnhem
• … и ещё 20 центров

Идентификаторы

NCT: NCT06476119 · M24OTI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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