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Active, not recruiting Phase 3

ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer

NCT04134598 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2021-02-08
Last updated
2025-08-29

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Breast irradiation (RT)Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen

Breast irradiation (RT): Irradiation of volume's portion Index quadrant) or whole volume of the residual breast.

Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen: Adjuvant endocrine therapy as per local policy (letrozole/anastrozole/exemestane/tamoxifene for 5-year or switch schedules aromatase inhibitors/tamoxifen for 5-year).

Study summary

Rationale and relevance for patients and the scientific community. In low risk early stage patients ≥70 years, exclusive radiation therapy (RT) approach might be superior in terms of Health-Related Quality of Life (HRQoL), when compared to exclusive endocrine therapy (ET) following breast-conserving surgery (BCS). Assuming an equal rate of disease control, unnecessary long-term toxicity of ET may be avoided.

Eligibility

Sex
FEMALE
Min age
70 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Women aged ≥70 years; * histologically proven invasive adenocarcinoma of the breast; * pathological T1 (pT1) stage (clinical T1-2 \[cT1-2\] stage is allowed); * 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 by immunohistochemistry (IHC)-based on local assessment (consistent with 14th St. Gallen consensus definition): * ER/PgR+ (defined as ≥10% by IHC staining), * Human epidermal growth factor receptor 2 (HER2)- (0 or 1+ following IHC staining and proven negative by in-situ hybridization \[ISH\] in case of 2+), and * Ki67 ≤20% by IHC staining; * surgically treated with BCS with or without sentinel node biopsy (SNB); * no clinical evidence of distant metastases. Imaging work up is not mandatory to enter the trial. If there are signs/symptoms suggesting the presence of local relapse or distant metastasis, an appropriate work up should be performed according to the treating physician standard practice. A patient with confirmed local relapse or distant metastasis will no longer be eligible for the trial; * postoperative final surgical margins negative (no ink on tumor); * baseline HRQoL questionnaires completion; * adjuvant bisphosphonates and denosumab are allowed; * before patient registration/randomization, written informed consent must be given. Exclusion Criteria: * 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); * prior breast or thoracic RT; * known disorders associated with a higher risk for complications following RT such as collagen vascular disease, dermatomyositis, systemic lupus erythematosis or scleroderma; * prior diagnosis, detection, or treatment of any other invasive cancer (except basal or squamous cell carcinoma of the skin that has been definitely treated); * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before registration; * patients must not be considered a poor medical risk due to 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.

Primary outcome measure(s)

  • Patient reported outcome measures (PROM) HRQoL as assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 — Change from baseline at 24 months
    EORTC Quality of Life Questionnaire (QLQ) C30.The QLQ-C30 is a cancer HRQoL questionnaire using PROMs for individual patient management. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.
  • Time to ipsilateral breast tumor recurrence (IBTR) — 60 months
    Time to ipsilateral breast tumor recurrence (IBTR)

Trial sites (1)

FacilityCityRegionStatus
Azienda Ospedaliero-Universitaria Careggi, Florence University Florence Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04134598 on ClinicalTrials.gov ↗ ← All trials in Italy