Informations générales (source: ClinicalTrials.gov)
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence (EMBER-4)
Interventional
Phase 3
Eli Lilly and Company (Voir sur ClinicalTrials)
octobre 2022
mars 2032
18 octobre 2024
The main purpose of this study is to measure how well imlunestrant works compared to
standard hormone therapy in participants with early breast cancer that is estrogen
receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants
must have already taken endocrine therapy for two to five years and must have a
higher-than-average risk for their cancer to return. Study participation could last up to
10 years.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:40 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:27 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| CENTRE HOSPITALIER SUD FRANCILIEN | Contact (sur clinicalTrials) | ||||
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine-Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Catalan d'Oncologie - 66000 - Perpignan - Pyrénées-Orientales - France | Contact (sur clinicalTrials) | ||||
| Centre de cancérologie des Dentellières - 59300 - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| Centre de Cancérologie du Grand Montpellier - 34070 - Montpellier - Languedoc-Roussillon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Côte Basque - 64109 - Bayonne - Pyrénées-Atlantiques - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Pau - 64000 - Pau - Pyrénées-Atlantiques - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Intercommunal de Mont-de-Marsan et du Pays des Sources - 40024 - Mont-de-Marsan - Landes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Privé Saint-Grégoire - 35768 - Saint-Grégoire - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy - 57085 - Metz - Moselle - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Poitiers - 86021 - Poitiers - Vienne - France | Contact (sur clinicalTrials) | ||||
| CHD Vendee - 85000 - La Roche-sur-Yon - Vendée - France | Contact (sur clinicalTrials) | ||||
| CHRU de Brest - 29609 - Brest - Finistère - France | Contact (sur clinicalTrials) | ||||
| CHU Besançon - 25000 - Besançon - Doubs - France | Contact (sur clinicalTrials) | ||||
| Chu Grenoble Alpes - 38700 - La Tronche - Isère - France | Contact (sur clinicalTrials) | ||||
| Clinique Francois Chenieux - 87039 - Limoges - Haute-Vienne - France | Contact (sur clinicalTrials) | ||||
| Clinique Victor Hugo Le Mans - 72000 - Le Mans - Pays-de-la - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier La Rochelle-Ré-Aunis - Hôpital Saint Louis - 17019 - La Rochelle - Charente-Maritime - France | Contact (sur clinicalTrials) | ||||
| Henri Mondor Hospital - Créteil - Île-de-France - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive Jean Mermoz - 69008 - Lyon - Rhône-Alpes - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest - 33076 - Bordeaux - Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Lorraine Alexis Vautrin - 54519 - Vandoeuvre-lès-Nancy - Lorraine - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - 44805 - Saint Herblain - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51726 - Reims - Marne - France | Contact (sur clinicalTrials) | ||||
| Pole Santé République - 63050 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Polyclinique De Blois - 41260 - La Chaussée-Saint-Victor - Centre - France | Contact (sur clinicalTrials) | ||||
| Polyclinique de Gentilly - 54100 - Nancy - Meurthe-et-Moselle - France | Contact (sur clinicalTrials) | ||||
| Sainte Catherine Institut du Cancer Avignon Provence - 84918 - Avignon - Vaucluse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without
evidence of distant metastasis.
- Participants must have received at least 24 months but not more than 60 months of
any adjuvant ET, from time of adjuvant ET initiation.
- Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy
with a CDK4/6- or PARP- inhibitor.
- Must have an increased risk of disease recurrence based on clinical-pathological
risk features.
- Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate organ function.
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without
evidence of distant metastasis.
- Participants must have received at least 24 months but not more than 60 months of
any adjuvant ET, from time of adjuvant ET initiation.
- Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy
with a CDK4/6- or PARP- inhibitor.
- Must have an increased risk of disease recurrence based on clinical-pathological
risk features.
- Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate organ function.
- Have any evidence of metastatic disease (including contralateral ALN) or
inflammatory breast cancer at primary breast cancer diagnosis.
- Participants with more than a 6-month consecutive gap in therapy during the course
of prior adjuvant ET.
- Participants who have completed or discontinued prior adjuvant ET >6 months prior to
screening.
- Participants with a history of previous breast cancer are excluded, with the
exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 180 days
after the last dose of study intervention.
- Participant has previously received ET of any duration for breast cancer prevention
(tamoxifen or AIs) or raloxifene.
- Participants with a history of any other cancer.
- Have serious preexisting medical conditions that, in the judgment of the
investigator, would preclude participation in this study.