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Clinical Trials in Denmark / NCT03646955
Recruiting Not applicable

Partial Breast Versus no Irradiation for Women With Early Breast Cancer

NCT03646955 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2018-09-05
Last updated
2020-10-06

Condition(s) studied

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)

Trial sites (17)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT03646955 on ClinicalTrials.gov ↗ ← All trials in Denmark