At a glance
ClinicalIndex Comparison Record- ✓Female or male patients aged ≥18 years
- ✓Triple-negative breast cancer defined by ER/PR 0-9%, HER2 negative (0, 1+, or 2+ IHC without amplification on ISH)
- ✓Pathological stage I: pT1a/b/c (≤2 cm invasive component, no pT1mi), pN0 (no malignant cells, N0(i+) not allowed)
- ✓No nodal or distant metastases (cN0M0) on pre/post-operative imaging (18F-FDG-PET/CT mandatory in Netherlands; CT acceptable if 18F-FDG-PET/CT unavailable)
- ✕Prior history of invasive or non-invasive breast cancer, or ongoing breast cancer treatment
- ✕Multifocal, multicentric, or bilateral breast cancer at screening
- ✕Administration of neoadjuvant systemic therapy
- ✕Lymphovascular invasion on diagnostic biopsy or surgical specimen
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes
In Brief
An observational study evaluating Adjuvant chemotherapy and No adjuvant chemotherapy for Breast Cancer Stage I and Triple Negative Breast Cancer (TNBC). Currently recruiting, targeting 490 participants across 28 sites.
Detailed 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.
Study Details
Timeline
Interventions
adjuvant chemotherapy according to local/ national guidelines
no adjuvant chemotherapy