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New treatment option for Early Breast Cancer
Official title Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer
ClinicalTrials.gov ID: NCT07579286
What this study is testing
- What it's testing
- Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer. The main goal of the study is to abandon axillary surgery in patients over 59 years old with early, luminal A, clinical lymph node negative breast cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, women only
You may be able to join if
- HER2-negative breast cancer (ER +/ PR +), Ki67 \<= 30%, G1-2
- age\> 59 years.
- morphologically confirmed diagnosis of breast cancer, IA-IIA stage
- ECOG score 0-2.
- the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
You likely can't join if
- Inconsistency with inclusion criteria.
- stage T2-4, N1 or M1 cancer
- severe uncontrolled concomitant chronic diseases or acute diseases
- previous/concurrent malignancy or history of radiation therapy to the chest wall region
- any condition that is a contraindication to radiation therapy 5\. pregnancy
See the full eligibility criteria
- HER2-negative breast cancer (ER +/ PR +), Ki67 \<= 30%, G1-2
- age\> 59 years.
- morphologically confirmed diagnosis of breast cancer, IA-IIA stage
- ECOG score 0-2.
- the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
- patient is able to provide informed consent and sign approved consent forms to participate in the study.
- 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).
- N0 status of axillary lymph nodes according to ultrasound and SPECT-CT of the breast with 99mTc-Technetril.
- Inconsistency with inclusion criteria.
- stage T2-4, N1 or M1 cancer
- severe uncontrolled concomitant chronic diseases or acute diseases
- previous/concurrent malignancy or history of radiation therapy to the chest wall region
- any condition that is a contraindication to radiation therapy 5\. pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russian Federation, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russian Federation, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.