Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT06637202
Swebcg 91:A RT. Breast Conserving Surgery With or Without Radiotherapy for Breast Cancer Patients
A study testing postoperative radiotherapy in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- postoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,187 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 1991to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- female
- not over the age of 75 years
- operated because of stage 1-2 invasive adenocarcinoma of the breast
- radical excision of the tumour
Who cannot join
- earlier cancer except cancer in situ of the cervix or skin
- distant metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- postoperative radiotherapy
- Keywords
- breast cancer, radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative radiotherapyRadiation
50 Gy in 25 fractions
| Study group | Role | What they receive |
|---|---|---|
| postoperative radiotherapy | Active comparator | Patients were treated with radiotherapy to 50 Gy in 25 fractions Receives: Radiation: postoperative radiotherapy |
| control | No intervention | Patients received no further treatment after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco-regional recurrence
Recurrence in the breast or regional lymph nodes
Measured: 35 years
Secondary outcomes (2)
survival
Does radiotherapy have an impact on survival?
Measured: 35 years
Secondary malignancies
Does radiotherapy have an impact on secondandary malignancies?
Measured: 35 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 1991
- Primary completion31 Dec 1996
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karlsson Per, MD, prof, Principal investigator, Göteborg University, Västra Götaland RegionErik Holmberg, PhD, Principal investigator, Göteborg UniversityEmma Nimeus Malmström, MD, ass prof, Principal investigator, Lund University, Region SkaneFredrika Killander, MD, PhD, Principal investigator, Region Skane, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637202
- Sponsor's protocol ID
- LU 80/90
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This trial started in 1990
Publications
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.
PubMed 36599119Strell 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.
PubMed 33661437Sjostrom 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.
PubMed 31618132Sjostrom 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.
PubMed 31558478Stenmark 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.
PubMed 37208129Stenmark 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.
PubMed 37071498Egelberg 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.
PubMed 36975842Tutzauer 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.
PubMed 35140341Killander 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.
PubMed 32302682Stenmark 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.
PubMed 33148672Sjostrom 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.
PubMed 32946618Killander 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.
PubMed 27614164Lundstedt 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.
PubMed 20970212Egelberg 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.
PubMed 40022029
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06637202
- Acronym / sponsor ID
- LU 80/90
- Keywords
- breast cancer, radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,187 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jan 1991 (actual)
- Primary completion
- 31 Dec 1996 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative radiotherapy | Active comparator | Radiation: postoperative radiotherapyPatients were treated with radiotherapy to 50 Gy in 25 fractions |
| control | No intervention | –Patients received no further treatment after surgery |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- female
- not over the age of 75 years
- operated because of stage 1-2 invasive adenocarcinoma of the breast
- radical excision of the tumour
Key exclusion criteria (2 listed)
- earlier cancer except cancer in situ of the cervix or skin
- distant metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative radiotherapy50 Gy in 25 fractions | Radiation | postoperative radiotherapy |
Primary outcome
Loco-regional recurrence
Time frame: 35 years
Recurrence in the breast or regional lymph nodes
2 secondary outcomes
survival
Time frame: 35 years
Secondary malignancies
Time frame: 35 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Results publication: PubMed 36599119Sjostrom 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.
- Results publication: PubMed 33661437Strell 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.
- Results publication: PubMed 31618132Sjostrom 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.
- Results publication: PubMed 31558478Sjostrom 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.
- Results publication: PubMed 37208129Stenmark 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.
- Results publication: PubMed 37071498Stenmark 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.
- Results publication: PubMed 36975842Egelberg 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.
- Results publication: PubMed 35140341Tutzauer 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.
- Results publication: PubMed 32302682Killander 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.
- Results publication: PubMed 33148672Stenmark 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.
- Results publication: PubMed 32946618Sjostrom 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.
- Results publication: PubMed 27614164Killander 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.
- Individual participant dataSharing planned: No. This trial started in 1990
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karlsson Per, MD, prof principal investigator
Göteborg University, Västra Götaland Region
Erik Holmberg, PhD principal investigator
Göteborg University
Emma Nimeus Malmström, MD, ass prof principal investigator
Lund University, Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative radiotherapy in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loco-regional recurrence (time frame: 35 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06637202, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.