An interventional study of No partial breast irradiation in Local Neoplasm Recurrence, Distantly Metastatic Malignant Neoplasm and Death, sponsored by Danish Breast Cancer Cooperative Group. Recruiting at 17 sites in 4 countries. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Danish Breast Cancer Cooperative Group · Not applicable, Interventional, and Treatment
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.
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.
43 studies on the registry are indexed under Neoplasm Recurrence, Local; 15 are open to participants now.
This study's planned enrollment of 926 is above the median of 237 across 30 interventional studies indexed under Neoplasm Recurrence, Local.
Browse Neoplasm Recurrence, Local studies →Danish Breast Cancer Cooperative Group is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Female patient >=60 years
Primary tumour characteristics by conventional histopathology
Surgical type is breast conservation
Performance status 0-2
No evidence of distant
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
External beam irradiation 40 Gy / 15 fractions, 5 fractions per week, 3 weeks
Radiation: No partial breast irradiation
No radiation therapy
Omission of radiation therapy
Invasive local recurrence
Invasive local recurrence
Time frame: 10 years
Regional nodes recurrence
Invasive recurrence in regional nodes of the treated breast
Time frame: 10 years
Distant failure
Invasive recurrence from the breast cancer outside the loco-regional area
Time frame: 10 years
Death
Death and cause of death
Time frame: 10 years
Plan to share: Yes — When the results from the trial are published, the DBCG RT Committee can decide that the results may be part of a meta-analysis.
Supporting information: Study protocol
Time frame: It will only be possible if the DBCG Radiation Therapy Committee decides that it is acceptable
Access criteria: The DBCG Radiation Therapy Committee will define the criteria after publication of the results from the trial
No publications or documents are linked to this record.
Started Sep 2018 (actual). Primary completion is estimated for Sep 2033, 179 months after the start.
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Danish Breast Cancer Cooperative Group