Exclusive hormonal therapy or exclusive irradiation of a small volume of operated breast for older adults aged >=70 years affected by low risk early stage breast cancer (EUROPA): a randomized noon inferiority phase 3 controlled trial.

Phase 1

• Conditions: Patients aged >=70 years with T1 N0 breast cancer (dimensions <2 cm and negative axillary lymph nodes) with luminal A-like characteristics (ER >=10% PgR >20% HER2 negative Ki67 <20%), after conservative surgery amenable with postoperative partial breast irradiation. The aim of the study is to evaluate the health-related quality of life (HRQoL) and safety of the irradiation arm.; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000428-21-IT
• Lead Sponsor: DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-10
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 962

Inclusion Criteria

--Women aged >=70 years;
-histologically proven invasive unifocal adenocarcinoma of the breast;
-pathological T1 (pT1) stage;
-postoperative negative (no ink) final surgical margins;
-clinical and pathological N0 (cN0 and pN0) stage (isolated tumour cells [i+] allowed);
-any tumour grade (if pT =10 mm), G1-2 tumour grade (if pT between 11 and 19 mm);
- luminal A-like biology (immunohistochemistry (IHC)-based on local assessment [49]):
- ER positive (defined as =10%);
- Progesterone (PgR) positive (defined as >20%);
- 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 <20% by IHC staining;
-surgically treated with BCS with or without sentinel node biopsy (SNB);
- written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 962

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 oestrogen 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 definitely treated), unless in clinical remission at the time of randomization.

Study & Design

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