De-escalation in Axillary Surgery for Early-stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sentinel lymph node biopsy, omission of sentinel lymph node biopsy.
- Who it may be relevant to
- Registry conditions: Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer. Basic parameters: from 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-world Integration of De-Escalation in Axillary Surgery for Postmenopausal, Early Stage HR+HER2- Breast Cancer Patients
Overview
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
Interventions
- Procedure sentinel lymph node biopsy
As sentinel lymph node biopsy is still a standard of care in early-stage breast cancer surgery, it represents the intervention in the standard of care arm - Procedure omission of sentinel lymph node biopsy
omission of sentinel lymph node biopsy is the intervention in the experimental arm
Primary outcome measures
- Isolated regional recurrence free survival [Time frame: 5 years]
- Disease free survival [Time frame: 5 years]
Secondary outcome measures (6)
- Isolated regional recurrence rate [Time frame: 5 years]
- Any invasive recurrence rate [Time frame: 5 years]
- Rate of adjuvant chemotherapy recommendation in standard and experimental arm [Time frame: 5 years]
- Rate of adjuvant regional nodal irradiation in standard and experimental arm [Time frame: 4 years]
- Rate of early postoperative complications in axilla in standard arm [Time frame: 3 years (accrual period)]
- Rate of late complications of axillary surgery in standard arm [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Croatia · 1 center
- Clinical Hospital Centre Rijeka — Rijeka
Identifiers
NCT: NCT07098507 · 2170-29-02/15-25-2