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POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer

NCT02401685 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1900

Last updated 2025-07-10

No results posted yet for this study

Summary

POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial.

Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years.

Stratification: Institution, Age (\<50, ≥50), Breast-conserving surgery (BCS) or mastectomy, Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2), Intra-operative sentinel assessment using OSNA (yes, no).

Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)).

Sample Size: 1900 participants

Follow-up: Participants will be followed up for 5 years.

Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.

Conditions

Interventions

OTHER

Adjuvant therapy

Adjuvant therapy will include chemotherapy and/or endocrine therapy for all women, and radiotherapy to breast or chest wall if indicated. Human epidermal growth factor receptor 2 (HER2) targeted treatment may also be administered when indicated.

PROCEDURE

Axillary treatment

Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Sussex Health Outcomes Research & Education in Cancer (SHORE-C)

    collaborator UNKNOWN

  • NCRI Radiotherapy Trials QA Group (RTTQA)

    collaborator UNKNOWN

  • Breast Cancer Trials, Australia and New Zealand

    collaborator OTHER

  • University Hospitals of Derby and Burton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Amit Goyal · University Hospitals of Derby and Burton NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Australia
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401685 on ClinicalTrials.gov