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Clinical Trials/NCT06637202
NCT06637202
Active, not recruiting
Not Applicable

SB (Swedish Breast Cancer Group) 91:A Breast Conserving Surgery With or Without Postoperative Radiotherapy for Breast Cancer Stage 1-2 (<30 mm) pN0, M0

Region Skane1 site in 1 country1,187 target enrollmentJanuary 1, 1991
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ConditionsBreast Cancer Early Stage Breast Cancer (Stage 1-3)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Sponsor
Region Skane
Enrollment
1187
Locations
1
Primary Endpoint
Loco-regional recurrence
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The main goal of the trial was to analyse the value of radiotherapy after breast conserving surgery for patients with breast cancer, and to find groups of patients where the treatment could be omitted.

Detailed Description

The trial recruited patients between 1991-1996, and the primary outcome in terms of recurrences has been updated through the years since then. Tumour material has been collected in order to study prognostic and predictive factors for breast cancer patients that are treated today. Late side effects of the treatment are studied.

Registry
clinicaltrials.gov
Start Date
January 1, 1991
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •not over the age of 75 years
  • •operated because of stage 1-2 invasive adenocarcinoma of the breast
  • •radical excision of the tumour

Exclusion Criteria

  • •earlier cancer except cancer in situ of the cervix or skin
  • •distant metastases

Outcomes

Primary Outcomes

Loco-regional recurrence

Time Frame: 35 years

Recurrence in the breast or regional lymph nodes

Secondary Outcomes

  • survival(35 years)
  • Secondary malignancies(35 years)

Study Sites (1)

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