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

The Netherlands Cancer Institute28 sites in 1 country490 target enrollmentApril 15, 2025

ConditionsBreast Cancer Stage I Triple Negative Breast Cancer (TNBC)

InterventionsNo adjuvant chemotherapy Adjuvant chemotherapy

DrugsAdjuvant chemotherapy

Overview

Phase: Not Applicable
Intervention: No adjuvant chemotherapy
Conditions: Breast Cancer Stage I
Sponsor: The Netherlands Cancer Institute
Enrollment: 490
Locations: 28
Primary Endpoint: Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 15, 2025

End Date

September 15, 2034

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

The Netherlands Cancer Institute

Responsible Party

Sponsor

Eligibility 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 \[including at least sentinel lymph node procedure\]);

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.

Arms & Interventions

Optimisation cohort

patients will be treated with surgery and adjuvant radiotherapy following local/national guidelines, while chemotherapy will be omitted

Intervention: No adjuvant chemotherapy

Control cohort

patients will be treated with surgery, adjuvant radiotherapy and adjuvant chemotherapy following local/national guidelines

Intervention: Adjuvant chemotherapy

Outcomes

Primary Outcomes

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

Secondary Outcomes

Fear of recurrence(up to 2 years after inclusion)
Worries about health(up to 2 years after inclusion)
disease recurrence free survival (DRFS) - optimalisation cohort the intention-to-treat population(up to 96 months after inclusion of the last patient)
Recurrence-free survival (RFS) - control cohort(up to 96 months after inclusion of the last patient)
Overal Survival (OS) - optimalisation cohort per-protocol population(up to 96 months after inclusion of the last patient)
Overal Survival (OS) - optimalisation cohort intention-to-treat population(up to 96 months after inclusion of the last patient)
Overal Survival (OS) - control 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(up to 2 years after inclusion)
Cost effectiveness measured per incremental cost-effectiveness ratio (ICER)(up to 2 years after inclusion)
Disease recurrence Free Interval (DRFI) - control cohort(up to 96 months after inclusion of the last patient)
Invasive disease-free survival (IDFS) - optimalisation cohort per-protocol population(up to 96 months after inclusion of the last patient)
Recurrence-free survival (RFS) - optimalisation cohort per-protocol population(up to 96 months after inclusion of the last patient)
Cost effectiveness measured by quality-adjusted-life years (QALYs)(up to 2 years after inclusion)
Invasive disease-free survival (IDFS) - control cohort(up to 96 months after inclusion of the last patient)
Recurrence-free survival (RFS) - optimalisation cohort the intention-to-treat population(up to 96 months after inclusion of the last patient)
Disease recurrence Free Interval (DRFI) - optimalisation cohort intention to treat population(up to 96 months after inclusion of the last patient)
Invasive disease-free survival (IDFS) - optimalisation cohort intention-to-treat population(up to 96 months after inclusion of the last patient)
disease recurrence free survival (DRFS) - optimalisation cohort per-protocol population(up to 96 months after inclusion of the last patient)
disease recurrence free survival (DRFS) - control 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-BR45(up to 2 years after inclusion)