Patologia: Neoplasie della mammella
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Linee di trattamento: Adiuvante/neoadiuvante
Criteri di inclusione:
- 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
Criteri di esclusione:
- 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.
Trattamento sperimentale:
Camizestrant (ARM B)
Trattamento di controllo:
Standard endocrine therapy of investigator´s choice (Arm A)
Obiettivi primari dello studio:
Invasive breast cancer-free survival (IBCFS)
Note generali:
NB: Oltre che nei Centri sotto elencati, lo studio è previsto anche nelle seguenti città:
- Napoli (80131): arr. attivo
- Napoli (80131): arr. non ancora attivo
- Bari (70124): arr. non ancora attivo
- Catania (95126): arr. non ancora attivo
- Catanzaro (88100): arr. non ancora attivo
IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
NB: Arruolamento pazienti non ancora attivo
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
NB: Arruolamento pazienti non ancora attivo
Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
NB: Arruolamento pazienti non ancora attivo
A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
NB: Arruolamento pazienti non ancora attivo
AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
Arcispedale Santa Maria Nuova
AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
A.U.S.L. 9 Grosseto
Via Senese - 58100 Grosseto - GR
Ospedale Misericordia
AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
NB: Arruolamento pazienti non ancora attivo
Numero di iscrizione a registro: NCT05774951
Data di inserimento: 15.12.2023
AstraZeneca
Riferimento: Dr. Info non disponibile
Telefono: 00000
Email: nd@nd.it
Localita: nd