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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
EU CTIS ID: 2023-508094-88-00
What this study is testing
- 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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.