CAMIZESTRANT for Early breast cancer (ER-positive, HER2-negative)

Inclusion criteria

• {"criterion_text":"- Women and Men; ≥18 years at the time of screening (or per national guidelines)\n- Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol\n- 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\n- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n- Adequate organ and marrow function"}

Exclusion criteria

• {"criterion_text":"- Inoperable locally advanced or metastatic breast cancer\n- Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding\n- 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\n- Pathological complete response following treatment with neoadjuvant therapy\n- 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\n- Any evidence of severe or uncontrolled systemic diseases which, in the investigator’s opinion precludes participation in the study or compliance\n- Known LVEF <50% with heart failure NYHA Grade ≥2\n- Mean resting QTcF interval > 480 ms at screening\n- Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions\n- SUB-STUDY ONLY: Initiation of restricted medications prior to randomisation in main study. Patients assessed as not able to comply with study procedures, restrictions, and requirements\n- SUB-STUDY ONLY: Comorbidities or concomitant medications; ongoing skin conditions, bleeding of unknown aetiology that might impact assessment of sub-study objectives.\n- Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)\n- Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant\n- For PORTUGAL ONLY: Patients with known germline or somatic BRCA1/2 mutations."}

Primary endpoints

• {"endpoint_text":"- Primary efficacy IBCFS (invasive breast cancer free-survival) as defined by STEEP 2.0 criteria","definition_or_measurement_approach":"IBCFS defined and measured according to STEEP 2.0 criteria"}

Secondary endpoints

• {"endpoint_text":"- Secondary efficacy IDFS(invasive disease-free survival) as defined by STEEP 2.0 criteria DRFS(distant relapse-free survival) as defined by STEEP 2.0 criteria OS(overall survival)","definition_or_measurement_approach":"IDFS, DRFS and OS defined and measured according to STEEP 2.0 criteria"}
• {"endpoint_text":"- Secondary safety Safety endpoints including: • TEAEs(treatment-emergent adverse event), SAEs(serious adverse event) • Clinical laboratory tests and vital signs","definition_or_measurement_approach":"Safety assessed by recording TEAEs and SAEs, clinical laboratory tests and vital signs"}
• {"endpoint_text":"- Secondary COAs(clinical outcome assessment): Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT","definition_or_measurement_approach":"Patient-reported tolerability assessed using the PGI-TT instrument (proportion of time on treatment with high side-effect burden)"}
• {"endpoint_text":"- Secondary COAs (clinical outcome assessment) Change from baseline and TTD(time to deterioration ) of health-related QoL(quality of life) as measured by the 2 global QoL (quality of life) items from the EORTC IL-311 (European Organisation for Research and Treatment of Cancer)","definition_or_measurement_approach":"Health-related QoL measured using two global QoL items from the EORTC IL-311; change from baseline and time to deterioration (TTD) evaluated"}
• {"endpoint_text":"- Secondary PK(pharmacokinetic(s) Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)","definition_or_measurement_approach":"Pharmacokinetics assessed by plasma pre-dose (Ctrough) concentrations of camizestrant"}

Methods

• Digital marketing (Trialbee) — patient landing pages and digital ad campaigns (Trialbee Patient Landing Page, Trialbee Digital Marketing Content) described in recruitment materials
• Consent Navigator / LongBoat tools — interactive consent navigator and patient handouts (Consent Navigator materials, patient handout documents)
• Doctor-to-patient letters — local clinician letters to inform potentially eligible patients (Dr-to-Pt Letter documents)
• Printed materials — tri-fold brochures and patient handouts for clinic distribution
• Informed consent animation — animated consent materials to support understanding
• Study landing pages and privacy/cookie statements — dedicated landing pages per country to route potential participants

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Fortrea Clinical Development Limited

Responsibilities

Sponsor duties codes: 1,12

Name

Fortrea Inc.

Responsibilities

Sponsor duties codes: 1,10,11,12,13,2,5,6,8

Third parties

• {"country":"Spain","full_name":"Solti Group","duties_or_roles":"Codes: 1,12,15,2,5,6,7,8,9 (includes 'CSA negotiation, Document Handling/Filing' where specified)","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Fortrea Clinical Development Limited","duties_or_roles":"Codes: 1,12","organisation_type":"Industry"}
• {"country":"France","full_name":"Unicancer","duties_or_roles":"Codes: 1,12,15,2,5,7,8,9 (includes 'CSA negotiation, Document Handling/Filing' where specified)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"GBG Forschungs GmbH","duties_or_roles":"Codes: 1,12,15,2,5,7,8,9 (includes 'CSA negotiation, Document Handling/Filing' where specified)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Cancer Trials Ireland","duties_or_roles":"Codes: 1,12,15,2,5,7,8,9 (includes 'CSA negotiation, Document Handling/Filing' where specified)","organisation_type":"Patient organisation/association"}
• {"country":"Austria","full_name":"ABCSG Research Services GmbH","duties_or_roles":"Codes: 1,10,11,12,13,15 (Protocol development, CSA negotiation, Document Handling/Filing, and other duties as listed)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Codes: 1,10,11,12,13,2,5,6,8 (various operational duties)","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Fundacion Grupo Espanol De Investigacion En Cancer De Mama","duties_or_roles":"Codes: 1,12,15,2,5,7,8,9 (includes 'CSA negotiation, Document Handling/Filing' where specified)","organisation_type":"Patient organisation/association"}
• {"country":"Germany","full_name":"GBG (additional entries as partner)","duties_or_roles":"","organisation_type":"Research / academic partner"}