Actively Recruiting
The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women 60 Years and Older After Breast Conservation for Early Breast Cancer
Led by Danish Breast Cancer Cooperative Group · Updated on 2020-10-06
926
Participants Needed
17
Research Sites
104 weeks
Total Duration
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Sponsors
D
Danish Breast Cancer Cooperative Group
Lead Sponsor
D
Danish Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether some women aged 60 or older with early breast cancer can safely skip radiation therapy after breast conserving surgery. The study focuses on patients with low-risk breast cancer, aiming to identify who might avoid radiation without a high chance of cancer returning locally. This is important because radiation can cause both short-term and long-term side effects, and not all patients gain the same benefit from it. The trial compares two approaches: one group will receive partial breast irradiation using external beam radiation at a dose of 40 Gy divided into 15 fractions over 3 weeks, while the other group will receive no radiation therapy. This comparison will help determine if radiation can be omitted safely in selected low-risk patients. The study is randomized and does not use any masking or blinding. Participants will be monitored over 10 years to measure invasive local recurrence of cancer as the primary outcome. Researchers will also track regional lymph node recurrence, distant failure, and death. Patients will have regular assessments to evaluate these outcomes and any side effects. The total follow-up period ensures long-term safety and effectiveness data for the treatment approaches.
CONDITIONS
Brief 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
- Primary tumor is unilateral, unifocal, non-lobular histology grade 1-2
- Maximum microscopic tumor size is 20 mm or less
- No lymph node involvement based on sentinel or axillary node dissection
- Estrogen receptor expression is 10% or higher
- HER2 negative by immunohistochemistry or in situ hybridization
- Surgical resection margin of 2 mm or more for invasive carcinoma and any associated ductal carcinoma in situ
- Breast conservation surgery performed
- Performance status between ECOG 0 and 2
- 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 chest area
- Previous other cancer within 5 years except carcinoma in situ of cervix, endometrium, colon, or melanoma in situ
- Medical conditions preventing radiation therapy such as cardiovascular or lung disease, scleroderma, lupus
- Mental or psychiatric disorders affecting understanding of randomization and follow-up
- Known hereditary breast cancer or high genetic risk
- Life expectancy less than 10 years
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive either partial breast irradiation or no radiation therapy after breast-conserving surgery.
15 visits (5 visits per week for 3 weeks) for partial breast irradiation; no visits for no radiation therapy
Duration - Up to 10 years
Participants are monitored for local recurrence, regional nodes recurrence, distant failure, and survival outcomes.
Periodic visits as scheduled by the study for up to 10 years
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
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4
Rigshospitalet
Copenhagen, Denmark
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5
Herlev Hospital
Herlev, Denmark
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6
Naestved Hospital
Næstved, Denmark
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7
Odense University Hospital
Odense, Denmark
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8
Vejle Hospital
Vejle, Denmark
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9
Haukeland HUS
Bergen, Norway
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10
Nordlandssykehuset
Bodø, Norway
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11
Kristiansand Hospital
Kristiansand, Norway
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12
Oslo University Hospital, Radiumhospitalet
Oslo, Norway
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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
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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