Informations générales (source: ClinicalTrials.gov)
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence (CAMBRIA-1)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
mars 2023
mai 2036
05 avril 2025
This is a Phase III open-label study to assess if camizestrant improves outcomes compared
to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with
intermediate or high risk for disease recurrence who completed definitive locoregional
therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for
at least 2 years and up to 5 years. The planned duration of treatment in either arm of
the study is 60 months.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 12/06/2024 12:16:02 | Contacter | ||
| HOPITAL FOCH | Asmahane BENMAZIANE TEILLET | 05/05/2025 07:12:14 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 01012 - Bourg en Bresse - France | Contact (sur clinicalTrials) | ||||
| Research Site - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 14076 - Caen cedex 05 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 22190 - Plerin SUR MER - France | Contact (sur clinicalTrials) | ||||
| Research Site - 29107 - Quimper Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 30029 - Nimes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33000 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33077 - Bordeaux Cédex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 35042 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 37044 - Tours CEDEX - France | Contact (sur clinicalTrials) | ||||
| Research Site - 42270 - St-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44202 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44805 - Saint Herblain Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 49055 - Angers Cedex 01 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 49300 - Cholet - France | Contact (sur clinicalTrials) | ||||
| Research Site - 56322 - Lorient cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 57085 - Metz Cedex 03 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 63011 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69310 - Pierre Benite - France | Contact (sur clinicalTrials) | ||||
| Research Site - 74370 - Epagny Metz-Tessy - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 84918 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92151 - Suresnes Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92210 - Saint Cloud - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94805 - Villejuif - France | Contact (sur clinicalTrials) | ||||
| Research Site - 95100 - Argenteuil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Women and Men, ≥18 years at the time of screening (or per national guidelines)
- Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with
high or intermediate risk of recurrence, based on clinical-pathological risk
features, as defined in the protocol.
- Completed adequate (definitive) locoregional therapy (surgery with or without
radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant
chemotherapy
- Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/-
CDK4/6 inhibitor)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Adequate organ and marrow function
- Women and Men, ≥18 years at the time of screening (or per national guidelines)
- Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with
high or intermediate risk of recurrence, based on clinical-pathological risk
features, as defined in the protocol.
- Completed adequate (definitive) locoregional therapy (surgery with or without
radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant
chemotherapy
- Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/-
CDK4/6 inhibitor)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Adequate organ and marrow function
- Inoperable locally advanced or metastatic breast cancer
- Pathological complete response following treatment with neoadjuvant therapy
- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of
the cervix or considered at very low risk of recurrence per investigator judgement)
unless in complete remission with no therapy for a minimum of 5 years from the date
of randomisation
- Any evidence of severe or uncontrolled systemic diseases which, in the
investigator's opinion precludes participation in the study or compliance
- Known LVEF <50% with heart failure NYHA Grade ≥2.
- Mean resting QTcF interval >480 ms at screening
- Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy
for non-cancer-related conditions
- Any concurrent anti-cancer treatment not specified in the protocol with the
exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg,
denosumab)
- Previous treatment with camizestrant, investigational SERDs/investigational ER
targeting agents, or fulvestrant
- Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding
- Patients with known hypersensitivity to active or inactive excipients of
camizestrant or drugs with a similar chemical structure or class to camizestrant. In
pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance
to LHRH agonists, that would preclude the patient from receiving any LHRH agonist