Partial Breast Versus no Irradiation for Women With Early Breast Cancer
NCT ID: NCT03646955
Last Updated: 2020-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
926 participants
INTERVENTIONAL
2018-09-05
2035-09-01
Brief Summary
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Detailed Description
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Based on early results from the randomized DBCG RT PBI trial, external beam 40 Gy/15 fr partial breast irradiation (PBI) has been standard in Denmark since April 2016 for selected low risk breast cancer patients. Based on results from the UK IMPORT LOW trial, the 5 yr local recurrence risk using this technique for PBI is 0.5%, whilst 2% for developing a new contralateral breast cancer.
This trial will investigate if PBI can safely be omitted in selected low risk breast cancer patients without causing unacceptable high risk of local failure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Partial breast irradiation
External beam irradiation 40 Gy / 15 fractions, 5 fractions per week, 3 weeks
No partial breast irradiation
Omission of radiation therapy
No partial breast irradiation
No radiation therapy
No interventions assigned to this group
Interventions
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No partial breast irradiation
Omission of radiation therapy
Eligibility Criteria
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Inclusion Criteria
Primary tumour characteristics by conventional histopathology
* unilateral and unifocal non-lobular histology grade 1-2
* maximum microscopic size \<=20mm
* node negative determined by sentinel node or axillary lymph node dissection
* estrogen receptor \>=10% positive
* HER2 negative (by IHC and/or in situ hybridization)
* resection margin \>=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer
Surgical type is breast conservation
Performance status ECOG 0-2
No evidence of distant metastasis
Exclusion Criteria
* evidence of clinical or pathological T4 breast cancer
* grade 3 malignancy
* previous breast cancer or DCIS irrespective of disease-free interval
* previous radiation therapy to the breast or thorax,
* previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.
* comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
* mental/psychiatric disorder which precludes the patient from understanding the randomization and the follow up.
* documented hereditary breast cancer or with high genetic risk of breast cancer
* life expectancy \<10 years
60 Years
FEMALE
No
Sponsors
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Danish Cancer Society
OTHER
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
OTHER
Danish Breast Cancer Cooperative Group
OTHER
Responsible Party
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Birgitte Offersen
Professor, PhD, MD
Principal Investigators
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Birgitte V Offersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Danish Breast Cancer Group
Locations
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Ponticia Universidad Catolica de Chile
Santiago, , Chile
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Naestved Hospital
Næstved, , Denmark
Odense University Hospital
Odense, , Denmark
Vejle Hospital
Vejle, , Denmark
Haukeland HUS
Bergen, , Norway
Nordlandssykehuset
Bodø, , Norway
Kristiansand Hospital
Kristiansand, , Norway
Oslo University Hospital, Radiumhospitalet
Oslo, , Norway
Stavanger Hospital
Stavanger, , Norway
Tromsø University Hospital
Tromsø, , Norway
Sahlgrenska University hospital
Gothenburg, , Sweden
Skånes University Hospital
Lund, , Sweden
Uppsala Akademiska Sjukhuset
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Tomas Merino Lara
Role: primary
Tamas Lörinz, MD
Role: primary
Hanne M Nielsen, PhD
Role: primary
Claus Kamby, DMSc
Role: primary
Louise W Matthiessen
Role: primary
Sami Al-Rawi, MD
Role: primary
Mette H Nielsen, PhD
Role: primary
Troels Bechmann, PhD
Role: primary
Hans Petter Eikesdal
Role: primary
Bård Mannsåker
Role: primary
Unn-Miriam Kasti
Role: primary
Kristin Reinertsen
Role: primary
Ingvil Mjaaland
Role: primary
Egil Blix Støre
Role: primary
Dan Lundstedt
Role: primary
Sara Alkner
Role: primary
Henrik Lindman
Role: primary
Other Identifiers
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DBCG RT Natural Trial
Identifier Type: -
Identifier Source: org_study_id
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