ExclUsive endocRine therapy Or radiation theraPy for women aged =70 years with luminal A-like early stage breast cancer (EUROPA): a randomized phase 3 trial

Phase 1

Recruiting

• Conditions: breast cancer; MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-508094-88-00
• Lead Sponsor: niversity Of Florence

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 926

Inclusion Criteria

Women aged =70 years, Histologically proven invasive adenocarcinoma of the breast, Pathological T1 (pT1) stage, Postoperative negative (no ink) final surgical margins, Clinical and pathological N0 (cN0 and pN0) stage (isolated tumor cells [i+] allowed), Any tumor grade (if pT =10 mm), G1-2 tumor grade (if pT between 11 and 19 mm), Luminal A-like biology (immunohistochemistry (IHC)-based on local assessment 50): ER and PgR positive (=10%); Human epidermal growth factor receptor 2 (HER2) negative (score 0 or 1+ and proven negative by in-situ hybridization [ISH] in case of score 2+); and Ki67 low (=20%) by IHC staining, Surgically treated with BCS with or without sentinel node biopsy (SNB), Written informed consent

Exclusion Criteria

Clinical evidence of DM or LR at baseline, Preoperative systemic treatments (i. e., chemotherapy, endocrine therapy)., Current treatment with any hormonal agents such as tamoxifen, raloxifene, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or BC prevention (patients are eligible if these medications are discontinued prior to randomization)., Known disorders associated with a higher risk for complications following RT such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma., Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule., Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder., No other cancers in the last 5 years (except basal or squamous cell carcinoma of the skin that has been treated), unless in clinical remission at the time of randomization., Synchronous diagnosis of bilateral breast cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To determine the IBTR rate of exclusive RT as compared to exclusive ET after BCS in low-risk early BC patients aged =70 years.<br>- To determine the PROMs HRQoL, as assessed by the QLQ-C30 and module BR45 questionnaires, of exclusive RT as compared to exclusive ET after BCS in low-risk early BC patients aged =70 years.;Secondary Objective: Safety, as assessed by the number and grade of participants with reported AEs., Individual scales from QLQ-C30 and module QLQ-BR45 scores., PROMs HRQoL measured by ELD14 questionnaire (optional)., Rate of cosmesis assessment grade., LRR, CBC, DM rate., BCSS and OS.;Primary end point(s): IBTR rate at 5 years., PROMs HRQoL measured by global quality of life score (QLQ-C30) using the GHS at 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):LRR rate at 5 years;Secondary end point(s):CBC rate at 5 years;Secondary end point(s):DM rate at 5 years;Secondary end point(s):BCSS at 5 years;Secondary end point(s):OS at 5 years;Secondary end point(s):Safety, as assessed by the number and grade of participants with reported AEs at 5 years;Secondary end point(s):Individual scales from QLQ-C30 and QLQ-BR45 scores at baseline, 3, 6, 12, 24 months, and 5 years;Secondary end point(s):Rate of cosmesis assessment grade at baseline, 3, 6, 12, 24 months, and 5 years;Secondary end point(s):PROMs HRQoL measured by ELD14 questionnaire (optional) at baseline, 12, 24 months, and 5 years