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Older women with Low-Risk breast cancer may avoid unnecessary surgery

NCT ID NCT07579286

Disease control Sponsor: N.N. Petrov National Medical Research Center of Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether women over 59 with a specific low-risk type of early breast cancer (luminal A) can safely skip sentinel lymph node biopsy, a standard surgical procedure to check if cancer has spread. The goal is to see if avoiding this biopsy leads to the same low rate of cancer coming back in the armpit area. About 100 participants will be followed and compared to those who received standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • N.N. Petrov National Medical Research Center of Oncology

    RECRUITING

    Saint Petersburg, Russian Federation, 197758, Russia

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