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study to validate and compare two techniques of axillary sampling (4 node sampling and low axillary sampling) with sentinel lymph node biopsy (SLNB) in patients suffering from locally advanced breast cancer for they have received neoadjuvant chemotherapy with cN0 axillary lymph node status

Axillary lymph node sampling (AS) in Post Neoadjuvant Chemotherapy (NACT) breast cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/05/019464
Enrollment
130
Registered
2019-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

None listed

Sponsors

Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Post NACT breast cancer patients (cT3/cT4, cN0) with clinically negative Axillary Lymph (ycN0) node status following chemotherapy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
ï?? Validate and compare two techniques of axillary sampling: 4 Node Axillary sampling and Low Axillary Sampling. Timepoint: Between February 2019 to February 2020—

Secondary

MeasureTime frame
Depending on results, If IR is at least 80-85% then we will compare the better of the aforementioned techniques with SLNBTimepoint: For second aim- based on 80% identification rate and power of 80% a non-inferiority comparison would require a minimum of 52 patients in each arm (considering 5% drop outs). This will be done between March 2010 to March 2021—

Countries

India

Contacts

Public ContactDr vikram S

Sanjay Gandhi Postgraduate Institute of Medical Sciences

anjali@sgpgi.ac.in9415142230

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026