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Study identifier: NCT03870919 Synced from ClinicalTrials.gov · August 03, 2026
● Active Not Recruiting

Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients

Condition: Breast Cancer Stage IV · Radiotherapy · Surgery  ·  Sponsor: UNICANCER

PhaseNA
Planned participants200
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 benef…

This description comes directly from the study's public registry record.

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Locations (26)

Institut de Cancérologie de l'Ouest-Site Paul PapinAngers, France
Institut Sainte CatherineAvignon, France
Centre François BaclesseCaen, France
Hôpital privé sainte MarieChalon-sur-Saône, France
CH CholetCholet, France
Centre Jean PerrinClermont-Ferrand, France
Centre George François LeclercDijon, France
Centre Léon BérardLyon, France
Hôpital St JosephMarseille, France
Institut Paoli CalmettesMarseille, France
Hôpital saint Eloi CHU MontpellierMontpellier, France
ICM Val d'AurelleMontpellier, France

+ 14 more locations — full list on the registry record.

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