The study is planned to observe and document the therapeutic decision-making process, treatment protocols, and clinical outcomes in patients with luminal breast cancer, whether they have undergone EndoPredict® testing or not
Age ≥ 18 years old.
Histological diagnosis of invasive breast cancer.
T1-T3 tumor size.
0-3 positive axillary lymph nodes.
History of another primary malignancy within the last 5 years, except for resected non-melanoma skin cancer.
Pre-operative chemotherapy administered.
Subject without signed and dated informed consent form.
All subjects diagnosed with invasive breast cancer, pT1-pT3, with 0 to 3 positive axillary lymph nodes, ER-positive, HER2-negative, that have not received neo-adjuvant chemotherapy and therefore are eligible for EndoPredict® testing.
Cohort
Prospective
Not listed
Distant relapse free survival (DRFS)
To collect and evaluate distant relapse-free survival (DRFS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
Overall Survival (OS)
To collect and evaluate overall survival (OS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
Distant relapse free interval (DRFI)
To collect and evaluate distant relapse free interval (DRFI) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
Proportion of adjuvant chemotherapy administration and association with baseline clinicopathologic characteristics and EPclin score
Proportion of participants who received adjuvant chemotherapy (yes/no) and its association with baseline clinicopathologic characteristics (age, menopausal status, nodal status, T stage, N stage, histologic grade) and EPclin score.
Local relapse free survival (LRFS)
To collect and evaluate local relapse free survival (LRFS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
Performance of EndoPredict (assessed with DRFS) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women]
Performance of EndoPredict in specific population subgroups \[multifocal-multicentric disease (MFMC), node-positive patients, pre-menopausal women\], assessed with distant recurrence free survival (DRFS).
Performance of EndoPredict (assessed with DRFI) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women]
Performance of EndoPredict in specific population subgroups \[multifocal-multicentric disease (MFMC), node-positive patients, pre-menopausal women\], assessed with distant recurrence free interval (DRFI).
OS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
OS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
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