Local Neoplasm RecurrenceDistantly Metastatic Malignant NeoplasmDeathFibrosis BreastDepigmentation/Hyperpigmentation of SkinTelangiectasiaScarPainPROMs
Investigational drug(s) / intervention(s)
No partial breast irradiation
No partial breast irradiation: Omission of radiation therapy
Study summary
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.
Eligibility
Sex
FEMALE
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Female patient \>=60 years
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:
* multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
* 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
Primary outcome measure(s)
Invasive local recurrence — 10 years Invasive local recurrence
Trial sites (17)
Facility
City
Region
Status
Ponticia Universidad Catolica de Chile
Santiago
Chile
Recruiting
Aalborg University Hospital
Aalborg
Denmark
Recruiting
Aarhus University Hospital
Aarhus
Denmark
Recruiting
Rigshospitalet
Copenhagen
Denmark
Recruiting
Herlev Hospital
Herlev
Denmark
Recruiting
Naestved Hospital
Næstved
Denmark
Recruiting
Odense University Hospital
Odense
Denmark
Recruiting
Vejle Hospital
Vejle
Denmark
Recruiting
Haukeland HUS
Bergen
Norway
Recruiting
Nordlandssykehuset
Bodø
Norway
Recruiting
Kristiansand Hospital
Kristiansand
Norway
Recruiting
Oslo University Hospital, Radiumhospitalet
Oslo
Norway
Recruiting
Stavanger Hospital
Stavanger
Norway
Recruiting
Tromsø University Hospital
Tromsø
Norway
Recruiting
Sahlgrenska University hospital
Gothenburg
Sweden
Recruiting
Skånes University Hospital
Lund
Sweden
Recruiting
Uppsala Akademiska Sjukhuset
Uppsala
Sweden
Recruiting
More Danish Breast Cancer Cooperative Group trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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