Informations générales (source: ClinicalTrials.gov)
A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer (SUMIT-ELA)
Interventional
Phase 1/Phase 2
Carrick Therapeutics Limited (Voir sur ClinicalTrials)
octobre 2023
juin 2025
16 novembre 2024
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and
efficacy of samuraciclib in combination with elacestrant in adult participants with
metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth
Factor Receptor (HER)2-negative breast cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/06/2024 14:01:16 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/12/2024 12:44:01 | 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 | |||||
| Site 80 - Centre Jean Bernard, Clinique Victor Hugo - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Site 82 - Institut de Cancerologie de Ouest (ICO) - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Site 83 - Institut Paoli Calmettes (IPC) - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or
metastatic breast cancer.
- Documented objective disease progression while on or within 6 months after the end
of the most recent therapy.
- Received prior AI in combination with a CDK4/6i as the last therapy
- Known TP53 and ESR1 mutation status.
- Participants must have measurable disease or bone only disease as defined by
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Pre/peri-menopausal participants must have commenced treatment with a luteinizing
hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of
study intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no
deterioration over the past 2 weeks.
- Expected life expectancy of >12 weeks in the judgement of the treating investigator.
- Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or
metastatic breast cancer.
- Documented objective disease progression while on or within 6 months after the end
of the most recent therapy.
- Received prior AI in combination with a CDK4/6i as the last therapy
- Known TP53 and ESR1 mutation status.
- Participants must have measurable disease or bone only disease as defined by
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Pre/peri-menopausal participants must have commenced treatment with a luteinizing
hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of
study intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no
deterioration over the past 2 weeks.
- Expected life expectancy of >12 weeks in the judgement of the treating investigator.
- Inflammatory breast cancer.
- Participants with any other active malignancy within 3 years prior to enrollment,
except for adequately treated basal cell or squamous cell skin cancer, or carcinoma
in situ of the cervix.
- More than 1 line of endocrine treatment for locally advanced or metastatic disease
treatment.
- Inadequate hepatic, renal, and bone marrow function.
- Clinically significant cardiovascular disease.
- Any current or prior central nervous system metastases, carcinomatous meningitis, or
leptomeningeal disease.
- Pregnant or breastfeeding women.