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No Axillary Surgery for Early Breast Cancer.

NCT03669705 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1584

Last updated 2018-09-13

No results posted yet for this study

Summary

After breast cancer (BC) screening was introduced for all Swedish women in 1989-90 the number of early invasive BC, clin N0 rose dramatically. For these BC it was known that only 10 % or less was N+ after axillary dissection and the morbidity for axillary surgery was substantial. Omitting axillary dissection in a randomized trial was ruled out because of anticipated few events. A national cohort was decided for invasive unifocal BC, histological grade 1 or 2, T=max 10mm, free margins, clin node neg. No axillary dissection should be undertaken. This was before the Sentinel Node era. Adjuvant treatment could be given according to regional guidelines for early breast cancer. Not uniform concerning postoperative radiotherapy and antihormonal treatment. Follow-up was clinical the first 5 years with mammography and then by hospital records and national Death register. Primary aim: Number of axillary recurrence and BC specific survival.

Conditions

  • Breast Cancer Invasive

Interventions

PROCEDURE

Omitting axillary surgery in early breast cancer

Before the Sentinel Node era all invasive breast cancer was recommended to have axillary dissection but after the introduction of national breast cancer screening this guideline statement was challenged by this national Swedish cohort.

Sponsors & Collaborators

  • Swedish Breast Cancer Group

    collaborator OTHER

  • Lund University

    lead OTHER

Principal Investigators

  • Christian Ingvar, Prof · Lund University

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-15
Primary Completion
2002-12-15
Completion
2017-12-31

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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 NCT03669705 on ClinicalTrials.gov