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This is a French observational, national, multicenter prospective cohort study of patients with HER2-negative eBC treated with olaparib at their physician's discretion.
The purpose to this observational study is to evaluate the rate of completion of adjuvant Olaparib treatment for HER2-negative early breast cancer patients in France.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who receive Olaparib for the full treatment duration | The primary outcome is the evaluation of the proportion of patients who receive Olaparib for the full treatment duration, described as 12 months of treatment. | 18 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| BRCA characteristics: Mutation type | Regarding BRCA characteristics: Mutation type: Tumoral (if only tumoral testing performed), somatic, germline. | 18 months after inclusion |
| Type of variants |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from about 60 participating sites to reach the target of 126 subjects, with a maximum of 60% of subtype TN overall.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Clermont-Ferrand | Auvergne-Rh ne-Alpes | 63050 | France | |
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Type of variants: BRCA1 and/or BRCA2, PALB2 mutation, presence of other HRR gene mutations, presence of other mutations
| 18 months after inclusion |
| Medical history | Family and personal history of cancer/type | 18 months after inclusion |
| Time to Olaparib treatment discontinuation | Time to Olaparib Treatment Discontinuation (TTD) or death | 18 months after inclusion |
| Research Site |
| Recruiting |
| Gleizé |
| Auvergne-Rh ne-Alpes |
| 69400 |
| France |
| Research Site | Not yet recruiting | Grenoble | Auvergne-Rh ne-Alpes | 38000 | France |
| Research Site | Recruiting | Lyon | Auvergne-Rh ne-Alpes | 69317 | France |
| Research Site | Recruiting | Metz-Tessy | Auvergne-Rh ne-Alpes | 74370 | France |
| Research Site | Not yet recruiting | Saint-Etienne | Auvergne-Rh ne-Alpes | 42030 | France |
| Research Site | Not yet recruiting | Saint-Priest-en-Jarez | Auvergne-Rh ne-Alpes | 42271 | France |
| Research Site | Recruiting | Thonon-les-Bains | Auvergne-Rh ne-Alpes | 74200 | France |
| Research Site | Recruiting | Valence | Auvergne-Rh ne-Alpes | 26000 | France |
| Research Site | Not yet recruiting | Valence | Auvergne-Rh ne-Alpes | 26953 | France |
| Research Site | Not yet recruiting | Dijon | Bourgogne-Franche-Comt | 21079 | France |
| Research Site | Recruiting | Plérin | Brittany Region | 22190 | France |
| Research Site | Not yet recruiting | Rennes | Brittany Region | 35042 | France |
| Research Site | Not yet recruiting | Saint-Brieuc | Brittany Region | 22027 | France |
| Research Site | Recruiting | Saint-Grégoire | Brittany Region | 35768 | France |
| Research Site | Recruiting | Chambray-lès-Tours | Centre-Val de Loire | 37170 | France |
| Research Site | Recruiting | Saint-Doulchard | Centre-Val de Loire | 18230 | France |
| Research Site | Recruiting | Bezannes | Grand Est | 51430 | France |
| Research Site | Not yet recruiting | Haguenau | Grand Est | 67504 | France |
| Research Site | Recruiting | Nancy | Grand Est | 54100 | France |
| Research Site | Recruiting | Beauvais | Hauts-de-France | 60021 | France |
| Research Site | Recruiting | Beuvry | Hauts-de-France | 62660 | France |
| Research Site | Not yet recruiting | Compiègne | Hauts-de-France | 60204 | France |
| Research Site | Not yet recruiting | Creil | Hauts-de-France | 60109 | France |
| Research Site | Recruiting | Dechy | Hauts-de-France | 59187 | France |
| Research Site | Not yet recruiting | Lille | Hauts-de-France | 59020 | France |
| Research Site | Not yet recruiting | Lille | Hauts-de-France | 59037 | France |
| Research Site | Not yet recruiting | Saint-Martin-Boulogne | Hauts-de-France | 62280 | France |
| Research Site | Recruiting | Salouël | Hauts-de-France | 80054 | France |
| Research Site | Not yet recruiting | Saint-Pierre-des-Corps | La R Union | 97448 | France |
| Research Site | Not yet recruiting | FORT de France Cedex | Martinique | 97261 | France |
| Research Site | Not yet recruiting | Agen | New Aquitaine | 47923 | France |
| Research Site | Not yet recruiting | Libourne | New Aquitaine | 33505 | France |
| Research Site | Not yet recruiting | Limoges | New Aquitaine | 87042 | France |
| Research Site | Recruiting | Périgueux | New Aquitaine | 24000 | France |
| Research Site | Recruiting | Poitiers | New Aquitaine | 86021 | France |
| Research Site | Recruiting | Caen | Normandy | 14000 | France |
| Research Site | Recruiting | Rouen | Normandy | 76175 | France |
| Research Site | Not yet recruiting | Béziers | Occitanie | 34500 | France |
| Research Site | Recruiting | Montpellier | Occitanie | 34070 | France |
| Research Site | Recruiting | Montpellier | Occitanie | 34298 | France |
| Research Site | Recruiting | Nîmes | Occitanie | 30900 | France |
| Research Site | Recruiting | Perpignan | Occitanie | 66046 | France |
| Research Site | Recruiting | Toulouse | Occitanie | 31300 | France |
| Research Site | Not yet recruiting | Nantes | Pays de la Loire Region | 44202 | France |
| Research Site | Not yet recruiting | Avignon | Provence-Alpes-C Te d'Azur | 84918 | France |
| Research Site | Not yet recruiting | Fréjus | Provence-Alpes-C Te d'Azur | 83608 | France |
| Research Site | Not yet recruiting | Marseille | Provence-Alpes-C Te d'Azur | 13385 | France |
| Research Site | Not yet recruiting | Nice | Provence-Alpes-C Te d'Azur | 06105 | France |
| Research Site | Not yet recruiting | Argenteuil | Île-de-France Region | 95107 | France |
| Research Site | Recruiting | Champigny-sur-Marne | Île-de-France Region | 94507 | France |
| Research Site | Not yet recruiting | Le Blanc-Mesnil | Île-de-France Region | 93150 | France |
| Research Site | Recruiting | Osny | Île-de-France Region | 95520 | France |
| Research Site | Recruiting | Paris | Île-de-France Region | 75651 | France |
| Research Site | Recruiting | Paris | Île-de-France Region | 75674 | France |
| Research Site | Not yet recruiting | Paris | Île-de-France Region | 75908 | France |
| Research Site | Not yet recruiting | Paris | Île-de-France Region | 75970 | France |
| Research Site | Recruiting | Sarcelles | Île-de-France Region | 95200 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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