Partial Breast Versus no Irradiation for Women With Early Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No partial breast irradiation.
- Who it may be relevant to
- Registry conditions: Local Neoplasm Recurrence, Distantly Metastatic Malignant Neoplasm, Death, Fibrosis Breast. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile, Denmark, Norway, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial
Overview
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.
Detailed description
International standard of therapy is to provide adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer to lower the risk of local and distant failures. However, breast cancer is a heterogeneous disease, and the gain from RT in selected low risk patients is low. RT may cause acute and late side effects, and some of these may be serious to the patient. Therefore, there is a need to tailor RT utilization to the individual recurrence risk and try identify patients who are unlikely to gain much risk reduction from RT, because those patients can then omit RT and thereby avoid late effects and over-treatment. At the present time there is no consensus as to define the selection criteria for patients who may omit RT.
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.
Interventions
- Radiation No partial breast irradiation
Omission of radiation therapy
Primary outcome measures
- Invasive local recurrence [Time frame: 10 years]
Secondary outcome measures (3)
- Regional nodes recurrence [Time frame: 10 years]
- Distant failure [Time frame: 10 years]
- Death [Time frame: 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 7 centers
- Aalborg University Hospital — Aalborg
- Aarhus University Hospital — Aarhus
- Rigshospitalet — Copenhagen
- Herlev Hospital — Herlev
- Naestved Hospital — Næstved
- Odense University Hospital — Odense
- Vejle Hospital — Vejle
Norway · 6 centers
- Haukeland HUS — Bergen
- Nordlandssykehuset — Bodø
- Kristiansand Hospital — Kristiansand
- Oslo University Hospital, Radiumhospitalet — Oslo
- Stavanger Hospital — Stavanger
- Tromsø University Hospital — Tromsø
Sweden · 3 centers
- Sahlgrenska University hospital — Gothenburg
- Skånes University Hospital — Lund
- Uppsala Akademiska Sjukhuset — Uppsala
Chile · 1 center
- Ponticia Universidad Catolica de Chile — Santiago
Identifiers
NCT: NCT03646955 · DBCG RT Natural Trial