Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Status:
Recruiting
Trial end date:
2026-10-23
Target enrollment:
Participant gender:
Summary
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic.
De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease
in mortality in Europe and North America due to early detection and access to treatment,
breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after
lung cancer and the world's leading cause.
In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen
receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months
overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In
the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone
receptor (HR)-positive / HER2-negative breast cancer.
The most important current treatment for metastatic breast cancer remains systemic therapy.
Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective
studies have assessed the impact of locoregional treatment on relapse and OS. These studies
suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks
to the addition of locoregional treatment to systemic therapy. Recent data from the ESME
cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer
may benefit from local treatment of the primary tumor.
Several prospective trials have attempted to demonstrate the benefit of locoregional
treatment with mixed results. This can be explained by a limited power of statistical
analysis, on the recruitment of patients with breast cancer of all types, and on a limited
access to effective systemic therapies in some cases and all before the area of anti CD4/6
which is the current standard treatment in patients with HR-positive / HER2-negative luminal
metastatic disease.
However, guidelines indicate that a "multimodal approach, including curative locoregional
treatments, should be considered". As a result, many clinicians offer locoregional treatment
of the primary tumor, especially if there is a good response to the first line of systematic
treatment.
Taken together, these data underscore the need for an evaluation of the value of combined
therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this
population of patients with newly diagnosed HR-positive / HER2-negative breast cancer.