Skipping sentinel lymph node biopsy for older women with luminal A early breast cancer

Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer

This trial tests whether women over 59 with early luminal A, node‑negative breast cancer can safely skip sentinel lymph node biopsy and have breast surgery guided by imaging instead.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 60 Years and up
• Sex: Female
• Sponsor: N.N. Petrov National Medical Research Center of Oncology (other)
• Drugs / interventions: radiation
• Locations: 1 site (Saint Petersburg, Russian Federation)
• Trial ID: NCT07579286 on ClinicalTrials.gov

What this trial studies

The trial enrolls women older than 59 with luminal A (ER+/PR+, HER2‑, Ki67 ≤30%, grade 1–2), clinically node‑negative IA–IIA breast cancer to compare breast resection with sentinel lymph node biopsy versus breast resection without axillary surgery. Eligibility requires negative axillary assessment by ultrasound and SPECT‑CT with 99mTc; patients are assigned to either SLNB or omission of axillary surgery. The main rationale is to determine if omitting SLNB reduces surgery‑related complications such as lymphedema and sensory deficits while maintaining oncologic safety in this low‑risk group. The protocol uses standard operative care and preoperative imaging to select patients and monitor outcomes.

Who should consider this trial

Good fit: Women older than 59 with morphologically confirmed early (IA–IIA) luminal A breast cancer (ER+/PR+, HER2‑, Ki67 ≤30%, grade 1–2), ECOG 0–2, and negative axillary status on ultrasound and SPECT‑CT are the intended candidates.

Not a fit: Patients with higher T stage, node‑positive disease, non‑luminal A subtypes, prior chest radiation, concurrent malignancy, or significant uncontrolled comorbidity are unlikely to benefit from skipping SLNB.

Why it matters

Potential benefit: If successful, patients could avoid axillary surgery and its risks, lowering lymphedema and arm morbidity and improving quality of life.

How similar studies have performed: Other trials (for example SOUND and INSEMA and related cohorts) have explored omitting SLNB in selected clinically node‑negative patients and generally indicate feasibility and low short‑term event rates in carefully selected groups, though long‑term data and subgroup specifics vary.

Eligibility criteria

Inclusion Criteria:

1. HER2-negative breast cancer (ER +/ PR +), Ki67 \<= 30%, G1-2
2. age\> 59 years.
3. morphologically confirmed diagnosis of breast cancer, IA-IIA stage
4. ECOG score 0-2.
5. the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
6. patient is able to provide informed consent and sign approved consent forms to participate in the study.
7. patients after surgical treatment in the scope of breast resection with sentinel lymph node biopsy (SLNB, group 1) or without axillary surgery (without SLNB, group 2).
8. N0 status of axillary lymph nodes according to ultrasound and SPECT-CT of the breast with 99mTc-Technetril.

Exclusion Criteria:

1. Inconsistency with inclusion criteria.
2. stage T2-4, N1 or M1 cancer
3. severe uncontrolled concomitant chronic diseases or acute diseases
4. previous/concurrent malignancy or history of radiation therapy to the chest wall region
5. any condition that is a contraindication to radiation therapy

5\. pregnancy

Where this trial is running

Saint Petersburg, Russian Federation

• N.N. Petrov National Medical Research Center of Oncology — Saint Petersburg, Russian Federation, Russia (RECRUITING)

Study contacts

• Study coordinator: Petr Krivorotko, Degree

Conditions: Early Breast Cancer, early breast cancer, radiotherapy, refusal of Sentinel Lymph Node Biopsy, SLNB, breast surgery, Mammolymphoscintigraphy