Last reviewed · How we verify

NCT03669705

No Axillary Surgery for Early Breast Cancer.

Completed Last updated 13 September 2018
What this trial tests

trial testing Omitting axillary surgery in early breast cancer in Breast Cancer Invasive in 1,584 participants. Completed in 31 December 2017.

Timeline
15 September 1997
Primary endpoint
15 December 2002
31 December 2017

Quick facts

Lead sponsorLund University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,584
Start date15 September 1997
Primary completion15 December 2002
Estimated completion31 December 2017

Drugs / interventions tested

Conditions studied

Sponsor

Lund University

Who can join

Eligibility, female only, with Breast Cancer Invasive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Breast Cancer Invasive

Currently open trials in the same condition.

Other Lund University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03669705.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing