Swebcg 91:A RT. Breast Conserving Surgery With or Without Radiotherapy for Breast Cancer Patients

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

• Registration Number: NCT06637202
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study Start: 1991-01-01
• Primary Completion: 1996-12-31
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1187

Inclusion Criteria

• female
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Loco-regional recurrence	35 years	Recurrence in the breast or regional lymph nodes

Secondary Outcome Measures

Name	Time	Method
survival	35 years	Does radiotherapy have an impact on survival?
Secondary malignancies	35 years	Does radiotherapy have an impact on secondandary malignancies?

Trial Locations

Locations (1)

Region Skane; 🇸🇪 Lund, Sweden