Actively Recruiting
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
Led by Danish Breast Cancer Cooperative Group · Updated on 2020-10-06
926
Participants Needed
17
Research Sites
886 weeks
Total Duration
On this page
Sponsors
D
Danish Breast Cancer Cooperative Group
Lead Sponsor
D
Danish Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.
CONDITIONS
Official Title
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patient aged 60 years or older
- Unilateral and unifocal non-lobular breast cancer with histology grade 1-2
- Maximum tumor size 20 mm by microscopic measurement
- Node negative by sentinel node or axillary lymph node dissection
- Estrogen receptor positive (10% or more)
- HER2 negative by immunohistochemistry or in situ hybridization
- Resection margin 2 mm or greater for invasive carcinoma and associated ductal carcinoma in situ
- Breast conserving surgery performed
- Performance status of 0 to 2 on the ECOG scale
- No evidence of distant metastasis
You will not qualify if you...
- Multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
- Clinical or pathological T4 breast cancer
- Grade 3 malignancy
- Previous breast cancer or ductal carcinoma in situ regardless of disease-free interval
- Previous radiation therapy to the breast or thorax
- Previous neoplasm within 5 years except certain in situ carcinomas or melanoma in situ
- Comorbidities preventing radiation therapy such as cardiovascular or pulmonary disease, scleroderma, or systemic lupus erythematosus
- Mental or psychiatric disorders preventing understanding of randomization and follow-up
- Documented hereditary breast cancer or high genetic risk
- Life expectancy less than 10 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Ponticia Universidad Catolica de Chile
Santiago, Chile
Actively Recruiting
2
Aalborg University Hospital
Aalborg, Denmark
Actively Recruiting
3
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
4
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
5
Herlev Hospital
Herlev, Denmark
Actively Recruiting
6
Naestved Hospital
Næstved, Denmark
Actively Recruiting
7
Odense University Hospital
Odense, Denmark
Actively Recruiting
8
Vejle Hospital
Vejle, Denmark
Actively Recruiting
9
Haukeland HUS
Bergen, Norway
Actively Recruiting
10
Nordlandssykehuset
Bodø, Norway
Actively Recruiting
11
Kristiansand Hospital
Kristiansand, Norway
Actively Recruiting
12
Oslo University Hospital, Radiumhospitalet
Oslo, Norway
Actively Recruiting
13
Stavanger Hospital
Stavanger, Norway
Actively Recruiting
14
Tromsø University Hospital
Tromsø, Norway
Actively Recruiting
15
Sahlgrenska University hospital
Gothenburg, Sweden
Actively Recruiting
16
Skånes University Hospital
Lund, Sweden
Actively Recruiting
17
Uppsala Akademiska Sjukhuset
Uppsala, Sweden
Actively Recruiting
Research Team
B
Birgitte V Offersen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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