Breast Cancer Stage I, Triple Negative Breast Cancer (TNBC)
Conditions
Keywords
High (stromal Tumor-Infiltrating-Lymphocytes) sTIL score
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.
Interventions
DRUGAdjuvant chemotherapy
adjuvant chemotherapy according to local/ national guidelines
no adjuvant chemotherapy
Sponsors
Maarten van de Weijden Foundation
AVL Foundation
The Netherlands Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population | 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
| Measure | Time frame | Description |
|---|---|---|
| Disease recurrence Free Interval (DRFI) - control cohort | up to 96 months after inclusion of the last patient | Number of patients with distant recurrence or death in control cohort |
| Invasive disease-free survival (IDFS) - optimalisation cohort per-protocol population | up to 96 months after inclusion of the last patient | Number of patients with breast tumor recurrence or death in the per-protocol population of the optimisation cohort |
| Invasive disease-free survival (IDFS) - optimalisation cohort intention-to-treat population | up to 96 months after inclusion of the last patient | Number of patients with breast tumor recurrence or death in the the intention-to-treat population of the optimisation cohort |
| Invasive disease-free survival (IDFS) - control cohort | up to 96 months after inclusion of the last patient | Number of patients with breast tumor recurrence or death in the control cohort |
| disease recurrence free survival (DRFS) - optimalisation cohort per-protocol population | up to 96 months after inclusion of the last patient | time between inclusion and first distant recurrence or death from any cause in the per-protocol population of the optimisation cohort |
| disease recurrence free survival (DRFS) - optimalisation cohort the intention-to-treat population | up to 96 months after inclusion of the last patient | time between inclusion and first distant recurrence or death from any cause in the intention-to-treat population of the optimisation cohort population of the optimisation cohort |
| disease recurrence free survival (DRFS) - control cohort | up to 96 months after inclusion of the last patient | time between inclusion and first distant recurrence or death from any cause in the control cohort |
| Recurrence-free survival (RFS) - optimalisation cohort per-protocol population | up to 96 months after inclusion of the last patient | time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the per-protocol population of the optimisation cohort; |
| Recurrence-free survival (RFS) - optimalisation cohort the intention-to-treat population | up to 96 months after inclusion of the last patient | time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the the intention-to-treat population of the optimisation cohort; |
| Disease recurrence Free Interval (DRFI) - optimalisation cohort intention to treat population | up to 96 months after inclusion of the last patient | Number of patients with distant recurrence or death in intention to treat population of the optimisation cohort |
| Overal Survival (OS) - optimalisation cohort per-protocol population | up to 96 months after inclusion of the last patient | time between inclusion and death from any cause in the per-protocol population of the optimisation cohort; |
| Overal Survival (OS) - optimalisation cohort intention-to-treat population | up to 96 months after inclusion of the last patient | time between inclusion and death from any cause in the the intention-to-treat population of the optimisation cohort; |
| Overal Survival (OS) - control cohort | up to 96 months after inclusion of the last patient | time between inclusion and death from any cause in the control cohort; |
| Health related Quality of Life (HRQoL) - (European Organisation on Research and Treatment of Cancer) EORTC questionnaire QLQ-C30 | up to 2 years after inclusion | Difference in QoL assessed with the EORTC QLQ-C30 questionnaires between the optimisation and the control group. A higher score indicates a higher symptom burden. |
| Health related Quality of Life (HRQoL) - (European Organisation on Research and Treatment of Cancer) EORTC questionnaire QLQ-BR45 | up to 2 years after inclusion | Difference in QoL assessed with the EORTC QLQ-BR45 questionnaires between the optimisation and the control group. A higher score indicates a higher symptom burden. |
| Fear of recurrence | up to 2 years after inclusion | Assessed with questionnaires to determine the difference in optimisation and control group |
| Worries about health | up to 2 years after inclusion | Assessed with questionnaires to determine the difference in optimisation and control group. A higher score indicates a higher symptom burden. |
| Cost effectiveness measured by quality-adjusted-life years (QALYs) | up to 2 years after inclusion | Measured per Quality-Adjusted Life Years (QALYs) |
| Cost effectiveness measured per incremental cost-effectiveness ratio (ICER) | up to 2 years after inclusion | Measured per incremental cost-effectiveness ratio (ICER) |
| Recurrence-free survival (RFS) - control cohort | up to 96 months after inclusion of the last patient | time between inclusion and invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence or death from any cause in the control cohort; |
Countries
Netherlands
Contacts
Primary ContactMarleen Kok, MD
Backup ContactRianne Rolfes, MD
Outcome results
None listed