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NCT Number: NCT06637202

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Region Skane

Lund, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative Radiotherapy

Radiation

50 Gy in 25 fractions

Primary outcomes

  1. Loco-regional recurrence

    Time frame: 35 years

    Recurrence in the breast or regional lymph nodes

Secondary outcomes

  1. survival

    Time frame: 35 years

    Does radiotherapy have an impact on survival?

  2. Secondary malignancies

    Time frame: 35 years

    Does radiotherapy have an impact on secondandary malignancies?

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
1991
Primary completion
1996
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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