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

NCT06637202 | Active Not Recruiting

• 1 other identifier: LU 80/90
• Study Type: interventional
• Target: 1,187
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

breast cancer; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Loco-regional recurrence

  Recurrence in the breast or regional lymph nodes

  35 years

Secondary Outcomes (2)

• survival

  35 years

• Secondary malignancies

  35 years

Study Arms (2)

postoperative radiotherapy

ACTIVE COMPARATOR

Patients were treated with radiotherapy to 50 Gy in 25 fractions

Radiation: postoperative radiotherapy

control

NO INTERVENTION

Patients received no further treatment after surgery

Interventions

postoperative radiotherapy RADIATION

50 Gy in 25 fractions

postoperative radiotherapy

Eligibility Criteria

• Age: Up to 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Region Skane

Lund, Sweden

Location

Related Publications (14)

• Sjostrom M, Fyles A, Liu FF, McCready D, Shi W, Rey-McIntyre K, Chang SL, Feng FY, Speers CW, Pierce LJ, Holmberg E, Ferno M, Malmstrom P, Karlsson P. Development and Validation of a Genomic Profile for the Omission of Local Adjuvant Radiation in Breast Cancer. J Clin Oncol. 2023 Mar 10;41(8):1533-1540. doi: 10.1200/JCO.22.00655. Epub 2023 Jan 4.

  PMID: 36599119 RESULT

• Strell C, Stenmark Tullberg A, Jetne Edelmann R, Akslen LA, Malmstrom P, Ferno M, Holmberg E, Ostman A, Karlsson P. Prognostic and predictive impact of stroma cells defined by PDGFRb expression in early breast cancer: results from the randomized SweBCG91RT trial. Breast Cancer Res Treat. 2021 May;187(1):45-55. doi: 10.1007/s10549-021-06136-4. Epub 2021 Mar 4.

  PMID: 33661437 RESULT

• Sjostrom M, Chang SL, Fishbane N, Davicioni E, Zhao SG, Hartman L, Holmberg E, Feng FY, Speers CW, Pierce LJ, Malmstrom P, Ferno M, Karlsson P. Clinicogenomic Radiotherapy Classifier Predicting the Need for Intensified Locoregional Treatment After Breast-Conserving Surgery for Early-Stage Breast Cancer. J Clin Oncol. 2019 Dec 10;37(35):3340-3349. doi: 10.1200/JCO.19.00761. Epub 2019 Oct 16.

  PMID: 31618132 RESULT

• Sjostrom M, Chang SL, Fishbane N, Davicioni E, Hartman L, Holmberg E, Feng FY, Speers CW, Pierce LJ, Malmstrom P, Ferno M, Karlsson P. Comprehensive Transcriptomic Profiling Identifies Breast Cancer Patients Who May Be Spared Adjuvant Systemic Therapy. Clin Cancer Res. 2020 Jan 1;26(1):171-182. doi: 10.1158/1078-0432.CCR-19-1038. Epub 2019 Sep 26.

  PMID: 31558478 RESULT

• Stenmark Tullberg A, Sjostrom M, Tran L, Nimeus E, Killander F, Kovacs A, Lundstedt D, Holmberg E, Karlsson P. Combining histological grade, TILs, and the PD-1/PD-L1 pathway to identify immunogenic tumors and de-escalate radiotherapy in early breast cancer: a secondary analysis of a randomized clinical trial. J Immunother Cancer. 2023 May;11(5):e006618. doi: 10.1136/jitc-2022-006618.

  PMID: 37208129 RESULT

• Stenmark Tullberg A, Sjostrom M, Nimeus E, Killander F, Chang SL, Feng FY, Speers CW, Pierce LJ, Kovacs A, Lundstedt D, Holmberg E, Karlsson P. Integrating Tumor-Intrinsic and Immunologic Factors to Identify Immunogenic Breast Cancers from a Low-Risk Cohort: Results from the Randomized SweBCG91RT Trial. Clin Cancer Res. 2023 May 1;29(9):1783-1793. doi: 10.1158/1078-0432.CCR-22-2746.

  PMID: 37071498 RESULT

• Egelberg M, De Marchi T, Pekar G, Tran L, Bendahl PO, Tullberg AS, Holmberg E, Karlsson P, Farnebo M, Killander F, Nimeus E. Low levels of WRAP53 predict decreased efficacy of radiotherapy and are prognostic for local recurrence and death from breast cancer: a long-term follow-up of the SweBCG91RT randomized trial. Mol Oncol. 2023 Oct;17(10):2029-2040. doi: 10.1002/1878-0261.13426. Epub 2023 Apr 19.

  PMID: 36975842 RESULT

• Tutzauer J, Sjostrom M, Holmberg E, Karlsson P, Killander F, Leeb-Lundberg LMF, Malmstrom P, Nimeus E, Ferno M, Jogi A. Breast cancer hypoxia in relation to prognosis and benefit from radiotherapy after breast-conserving surgery in a large, randomised trial with long-term follow-up. Br J Cancer. 2022 May;126(8):1145-1156. doi: 10.1038/s41416-021-01630-4. Epub 2022 Feb 9.

  PMID: 35140341 RESULT

• Killander F, Wieslander E, Karlsson P, Holmberg E, Lundstedt D, Holmberg L, Werner L, Koul S, Haghanegi M, Kjellen E, Nilsson P, Malmstrom P. No Increased Cardiac Mortality or Morbidity of Radiation Therapy in Breast Cancer Patients After Breast-Conserving Surgery: 20-Year Follow-up of the Randomized SweBCGRT Trial. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):701-709. doi: 10.1016/j.ijrobp.2020.04.003. Epub 2020 Apr 14.

  PMID: 32302682 RESULT

• Stenmark Tullberg A, Puttonen HAJ, Sjostrom M, Holmberg E, Chang SL, Feng FY, Speers C, Pierce LJ, Lundstedt D, Killander F, Nimeus E, Kovacs A, Karlsson P. Immune Infiltrate in the Primary Tumor Predicts Effect of Adjuvant Radiotherapy in Breast Cancer; Results from the Randomized SweBCG91RT Trial. Clin Cancer Res. 2021 Feb 1;27(3):749-758. doi: 10.1158/1078-0432.CCR-20-3299. Epub 2020 Nov 4.

  PMID: 33148672 RESULT

• Sjostrom M, Veenstra C, Holmberg E, Karlsson P, Killander F, Malmstrom P, Nimeus E, Ferno M, Stal O. Expression of HGF, pMet, and pAkt is related to benefit of radiotherapy after breast-conserving surgery: a long-term follow-up of the SweBCG91-RT randomised trial. Mol Oncol. 2020 Nov;14(11):2713-2726. doi: 10.1002/1878-0261.12803. Epub 2020 Sep 28.

  PMID: 32946618 RESULT

• Killander F, Karlsson P, Anderson H, Mattsson J, Holmberg E, Lundstedt D, Holmberg L, Malmstrom P. No breast cancer subgroup can be spared postoperative radiotherapy after breast-conserving surgery. Fifteen-year results from the Swedish Breast Cancer Group randomised trial, SweBCG 91 RT. Eur J Cancer. 2016 Nov;67:57-65. doi: 10.1016/j.ejca.2016.08.001. Epub 2016 Sep 7.

  PMID: 27614164 RESULT

• Lundstedt D, Gustafsson M, Malmstrom P, Johansson KA, Alsadius D, Sundberg A, Wilderang U, Holmberg E, Anderson H, Steineck G, Karlsson P. Symptoms 10-17 years after breast cancer radiotherapy data from the randomised SWEBCG91-RT trial. Radiother Oncol. 2010 Nov;97(2):281-7. doi: 10.1016/j.radonc.2010.09.018. Epub 2010 Oct 20.

  PMID: 20970212 RESULT

• Egelberg M, De Marchi T, Schultz N, Tran L, Karlsson P, Holmberg E, Pekar G, Killander F, Nimeus E. The potential radiosensitization target PFKFB3 is related to response to radiotherapy in SweBCG91RT: a randomized clinical trial with long-term follow-up. BMC Cancer. 2025 Feb 28;25(1):374. doi: 10.1186/s12885-025-13703-1.

  PMID: 40022029 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 1991
• Primary Completion: December 31, 1996
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)