- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669705
No Axillary Surgery for Early Breast Cancer.
September 12, 2018 updated by: Lund University
Prospective Cohort Study With no Axillary Surgery for Breast Cancer T</= 10 mm
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
1584
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axillary recurrence
Time Frame: at 15 years
|
Time to axillary node recurrence
|
at 15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breast cancer specific survival (BCSS)
Time Frame: at 15 years
|
Breast cancer specific survival
|
at 15 years
|
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
|
at 15 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Ingvar, Prof, Lund University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 1997
Primary Completion (Actual)
December 15, 2002
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
August 23, 2018
First Submitted That Met QC Criteria
September 12, 2018
First Posted (Actual)
September 13, 2018
Study Record Updates
Last Update Posted (Actual)
September 13, 2018
Last Update Submitted That Met QC Criteria
September 12, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97 02 12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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