De-escalation in Axillary Surgery for Early-stage Breast Cancer (NCT07098507) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
De-escalation in Axillary Surgery for Early-stage Breast Cancer
Croatia620 participantsStarted 2025-09-10
Plain-language summary
The goal of this clinical trial is to determine if the omission of sentinel lymph node biopsy is safe for early-stage breast cancer patients in our institution (Clinical Hospital Centre Rijeka).
Targeted group are postmenopausal patients, older than 55 years, diagnosed with hormone-receptor-positive breast cancer, with primary tumour less than 3 cm and unaffected axilla on clinical exam and axillary ultrasound.
The main questions we aim to answer are:
* if this treatment de-escalation affects patient oncological outcomes (cancer recurrence)?
* if this treatment de-escalation affects patient clinical outcomes (early and late complications related to axillary surgery)?
* if this omission of pathological examination of sentinel lymph node affects recommendations on postoperative treatments (irradiation and systemic therapy)? Researchers will compare outcomes between participants submitted to sentinel lymph node biopsy and participants in whom the procedure is omitted to answer those questions.
Participants will be asked to:
* decide in which group they wish to participate
* visit the clinic for checkups and tests once every 6 months in first two years and yearly thereafter up to 5 years
Who can participate
Age range
55 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:
* newly diagnosed hormone receptor positive, HER2 negative invasive breast cancer or DCIS with microinvasion, histologically confirmed, in postmenopausal patients older than 55 years, with primary tumour up to 3 cm and uninvolved axillary lymph nodes on clinical examination and on axillary ultrasound performed in Clinical Hospital Centre Rijeka. Patients should be eligible for breast conserving surgery and adjuvant whole breast irradiation.
Exclusion Criteria:
* Patients younger than 55 years of age and/or premenopausal, with cN1-3 status (confirmed cytologically or histologically), or with multiple suspicious lymph nodes on axillary ultrasound, regardless of cytological/histological confirmation.
* Patients diagnosed with pure breast carcinoma in situ (DCIS) without focal invasion
* Patients with tumour larger than 3 cm or with cT4 status, with de novo metastatic disease
* Patients with a breast cancer of HER2+ or triple-negative immunophenotype
* Patients who have received any type of neoadjuvant systemic therapy before surgery and those who have a previous personal history of invasive breast cancer
* Patients with extensive multifocal or multicentric breast cancer, patients scheduled for mastectomy, partial breast irradiation or who refuse recommended adjuvant systemic oncological treatment
* Patients who do not wish to participate in a clinical trial
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.