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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• N.N. Petrov National Medical Research Center of Oncology
  Saint Petersburg, Russian Federation, Russia Recruiting

Study contacts

• Study coordinator: Petr Krivorotko, Degree
• Email: dr.krivorotko@mail.ru
• Phone: +79219597722

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.