Last reviewed · How we verify
NCT03669705
No Axillary Surgery for Early Breast Cancer.
trial testing Omitting axillary surgery in early breast cancer in Breast Cancer Invasive in 1,584 participants. Completed in 31 December 2017.
15 December 2002
Quick facts
| Lead sponsor | Lund University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,584 |
| Start date | 15 September 1997 |
| Primary completion | 15 December 2002 |
| Estimated completion | 31 December 2017 |
Drugs / interventions tested
- Omitting axillary surgery in early breast cancer
Conditions studied
- Breast Cancer Invasive — all drugs for Breast Cancer Invasive →
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:
- PubMed search for NCT03669705
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03669705 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lund University
- Last refreshed: 13 September 2018
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