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Clinical Trials/2023-508094-88-00
2023-508094-88-00RecruitingPhase 3

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

University Of Florence19 sites in 1 country926 target enrollmentStarted: November 6, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
926
Locations
19
Primary Endpoint
IBTR rate at 5 years.
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

  • To determine the IBTR rate of exclusive RT as compared to exclusive ET after BCS in low-risk early BC patients aged ≥70 years.
  • 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.

Eligibility Criteria

Ages
65 years to 65+ years (65+ Years)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

IBTR rate at 5 years.

IBTR rate at 5 years.

PROMs HRQoL measured by global quality of life score (QLQ-C30) using the GHS at 24 months

PROMs HRQoL measured by global quality of life score (QLQ-C30) using the GHS at 24 months

Secondary Outcomes

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

Investigators

Sponsor Class
Educational Institution
Responsible Party
Principal Investigator
Principal Investigator

Lorenzo Livi

Scientific

University Of Florence

Study Sites (19)

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