No Axillary Surgery for Early Breast Cancer.

Breast Cancer Invasive Clinical Trial

Official title:

Prospective Cohort Study With no Axillary Surgery for Breast Cancer T</= 10 mm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669705
• Other study ID #: 97 02 12
• Status: Completed
• Start date: September 15, 1997
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2018
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

After national breast cancer screening was introduced in Sweden in 1989-90 the number of early invasive BC, clin N0 rose dramatically. Only 10 % or less of these was N+ after axillary dissection with a substantial morbidity after the axillary intervention. Omitting axillary dissection in a randomized trial was ruled out because of anticipated few events. A national cohort was decided for invasive unifocal BC, Screening or clinical diagnosis were eligible, only histological grade 1 or 2, T=max 10mm, free margins , clinical node negative. No axillary dissection should be undertaken, only radical removal of the breast cancer. (Note; This was before the Sentinel Node era). Adjuvant treatment could be given according to regional guidelines for early breast cancer as no regular national guidelines existed then concerning postoperative radiotherapy and antihormonal treatment. Chemotherapy was not recommended to this type of breast cancer. Follow-up was done by the treating surgeon the first 5 years including mammography. Then hospital records including mammography and reports from Pathology and Oncology and Death register were followed at intervals 5, 10 and 15 years. Primary aim: Number of axillary recurrence and distant metastases/ BC specific survival. Correlation to adjuvant therapy. Inclusion started in 1997 and ended in 2002. 1584 patients were included. If the axillary recurrence rate was more than 1% per year the first five years the inclusion should be stopped.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer Invasive
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Swedish Breast Cancer Group

Outcome

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