Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

No Axillary Surgery for Early Breast Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669705
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Swedish Breast Cancer Group
Information provided by (Responsible Party):
Lund University

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.

Condition or disease Intervention/treatment
Breast Cancer Invasive Procedure: Omitting axillary surgery in early breast cancer

Detailed 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1584 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study With no Axillary Surgery for Breast Cancer T</= 10 mm
Actual Study Start Date : September 15, 1997
Actual Primary Completion Date : December 15, 2002
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Axillary recurrence [ Time Frame: at 15 years ]
    Time to axillary node recurrence


Secondary Outcome Measures :
  1. Breast cancer specific survival (BCSS) [ Time Frame: at 15 years ]
    Breast cancer specific survival

  2. Breast cancer specific survival according to given adjuvant treatment [ Time Frame: at 15 years ]
    BCSS for patients given postop radiotherapy to the breast or no radiotherapy


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669705


Sponsors and Collaborators
Lund University
Swedish Breast Cancer Group
Investigators
Layout table for investigator information
Principal Investigator: Christian Ingvar, Prof Lund University
Layout table for additonal information
Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03669705    
Other Study ID Numbers: 97 02 12
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
Axillary Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases