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

October 10, 2024 updated by: Region Skane

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Region Skane

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

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: postoperative radiotherapy
Patients were treated with radiotherapy to 50 Gy in 25 fractions
Radiation: postoperative radiotherapy
50 Gy in 25 fractions
No Intervention: control
Patients received no further treatment after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loco-regional recurrence
Time Frame: 35 years
Recurrence in the breast or regional lymph nodes
35 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 35 years
Does radiotherapy have an impact on survival?
35 years
Secondary malignancies
Time Frame: 35 years
Does radiotherapy have an impact on secondandary malignancies?
35 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Karlsson Per, MD, prof, Göteborg University, Västra Götaland Region
  • Principal Investigator: Erik Holmberg, PhD, Göteborg University
  • Principal Investigator: Emma Nimeus Malmström, MD, ass prof, Lund University, Region Skane
  • Principal Investigator: Fredrika Killander, MD, PhD, Region Skane, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 1991

Primary Completion (Actual)

December 31, 1996

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LU 80/90

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This trial started in 1990

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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