Breast Cancer Invasive Clinical Trial
Official title:
Prospective Cohort Study With no Axillary Surgery for Breast Cancer T</= 10 mm
Verified date | September 2018 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1584 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 15, 2002 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Invasive breast cancer, unifocal - T=max 10mm - Clinical node negative and clinical M0 - Histological grade 1 or 2 - Both screening / clinical detected accepted - Radical operation = free margins in breast specimen - Partial mastectomy and mastectomy accepted - Fit to understand inclusion criteria Exclusion Criteria: - Previous breast cancer diagnosis, including carcinoma in situ - Previous ipsilateral axillary dissection - Non radical operation = no free margins - Multifocal cancer - Previous treatment for other cancer. - Unable to understand information (informed consent) - Bilateral breast cancer at diagnosis |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lund University | Swedish Breast Cancer Group |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Axillary recurrence | Time to axillary node recurrence | at 15 years | |
Secondary | Breast cancer specific survival (BCSS) | Breast cancer specific survival | at 15 years | |
Secondary | Breast cancer specific survival according to given adjuvant treatment | BCSS for patients given postop radiotherapy to the breast or no radiotherapy | at 15 years |
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