Título: Estudio en fase III, abierto y aleatorizado para evaluar la eficacia y la seguridad de camizestrant (AZD9833, un degradador selectivo del receptor de estrógenos por vía oral de última generación) frente a la hormonoterapia estándar (inhibidor de la aromatasa o tamoxifeno), como tratamiento adyuvante en pacientes con cáncer de mama en fase temprana RE+/HER2- y un riesgo intermedio-alto o alto de recidiva que han completado tratamiento locorregional definitivo y no presentan indicios de enfermedad Título corto: An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer

Especialidad: Oncología

Código de protocolo: D8535C00001

Número EudraCT: 2023-504031-41-00

Promotor: Astra Zeneca

Investigador principal: Dr. Javier Pascual López

Más información:

CRO: GEICAM

Criterios de inclusión: 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 absence of any evidence of metastatic disease 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. Patients must be randomised within 12 months of definitive breast surgery. Patients may have received up to 12 weeks of endocrine therapy either in the adjuvant orneoadjuvant setting prior to randomisation
Eastern Cooperative Oncology Group (ECOG) performance status of 1.
Adequate organ and marrow function.

Criterios de exclusión: Inoperable locally advanced or metastatic breast cancer
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
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 a 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 investigators 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.

Fecha firma: 16/06/2024

Estado: en marcha

Centro: Vithas Málaga