ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer (NCT04134598) | Clinical Trial Compass
Active — Not RecruitingPhase 3
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Italy926 participantsStarted 2021-02-08
Plain-language 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.
Who can participate
Age range
70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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., chemo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient reported outcome measures (PROM) HRQoL as assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Timeframe: Change from baseline at 24 months
2
Time to ipsilateral breast tumor recurrence (IBTR)