No Axillary Surgery for Early Breast Cancer.

NCT03669705 | Completed

• 1 other identifier: 97 02 12
• Study Type: observational
• Target: 1,584
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Axillary Surgery

Outcome Measures

Primary Outcomes (1)

• Axillary recurrence

  Time to axillary node recurrence

  at 15 years

Secondary Outcomes (2)

• Breast cancer specific survival (BCSS)

  at 15 years

• Breast cancer specific survival according to given adjuvant treatment

  at 15 years

Interventions

Omitting axillary surgery in early breast cancer PROCEDURE

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In five out of six regions in Sweden (West was involved in another international trial) patients were selected at the local breast cancer conference as eligible in this cohort (study approved by the Ethical board and the Swedish Breast cancer group) and then informed by the surgeon. If the patient accepted the patient was included (registered at the regional Cancer Registry) and the primary breast surgery was done without any axillary dissection. Follow-up included regular visits to the breast cancer unit and yearly mammography for 5-10 years and then biannually to 74 years of age. Thereafter only hospital records (including surgery, oncology and pathology) were reviewed at intervals as were the national Death registry. Median age at study start was 60 years.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Swedish Breast Cancer Group: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin fixed Breast cancer tissue from the primary operation. Most patients having had a recurrence will have a biopsy saved at the local department of Pathology in Sweden.

Study Officials

• Christian Ingvar, Prof

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 13, 2018
• Study Start: September 15, 1997
• Primary Completion: December 15, 2002
• Study Completion: December 31, 2017
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share