An interventional study of Proton versus photon radiation therapy in Early Breast Cancer and Radiation Associated Cardiac Failure, sponsored by Danish Breast Cancer Cooperative Group. Recruiting at 8 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Danish Breast Cancer Cooperative Group · Not applicable, Interventional, and Treatment
The majority of early breast cancer patients are treated with adjuvant radiation therapy (RT) as part of their multimodal therapy. The aim of the RT is to lower the risk of local, regional and distant failure and improve survival. Modern RT is been provided with photon therapy. Now, more proton therapy facilities are opened, including in Denmark. Proton RT may have the potential to cause lower dose to heart and lung during breast RT. This trial will randomise patients between standard photon RT versus experimental proton RT. The primary endpoint is 10 year risk of heart disease.
Adjuvant breast cancer radiation therapy (RT) is standard for all patients operated with breast conservation and for patients diagnosed with large tumours and/or node-positive disease. Around 65% of all breast cancer patients treated with RT have whole breast RT without nodal RT, whilst the remaining 35% are treated with loco-regional RT (target is breast / chest wall and regional nodal volumes). RT leads to fewer local and regional recurrences, a decrease in breast cancer death and improves overall survival. Since 2014, when the DBCG IMN study showed overall survival gain from internal mammary node (IMN) RT, IMN RT has been standard for all high-risk patients in Denmark. IMN RT causes a significant increase in dose to the heart and lung, thus heart and lung sparing RT techniques based on deep inspiration breath hold (DIBH), volumetric arc therapy and tomotherapy are increasingly used to lower dose to heart and lung whilst maintaining dose to breast and nodal targets. These advanced techniques are used in all DBCG departments routinely. Despite using advanced RT techniques, some patients still receive high RT dose to heart and lung.
Proton therapy (PT) has not been widely used nor investigated for adjuvant breast cancer RT, because there are only few proton centres. However, due to the properties of PT it is possible to achieve optimal dose coverage of relevant targets and at the same time ensure low dose to organs at risk compared with photon RT. In an energy-dependent manner, PT will deposit the majority of its dose in tissue depths defined by the Bragg peak. In practice, this translates into i) the ability to deliver the peak energy to target volumes of irregular 3-dimensional shape using pencil-beam scanning technology, ii) a sharp dose fall-off following deposition of energy in the target and iii) reduction of the integral dose to the patient. Within millimeters, the exit dose drops off from 90% to 10%, resulting in the virtual absence of an exit dose. The effectiveness, safety and feasibility of PT has been reported in few small cohort studies with limited follow up, and there is a lack of clinically controlled randomised trials documenting benefit from PT, evaluated either as higher tumour control and/or as fewer morbidities.
This trial tests standard photon RT versus experimental proton RT for selected early breast cancer patients.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 1,502 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms 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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
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.
The patient is treated with standard radiation therapy based on photons
Radiation: Proton versus photon radiation therapy
The patient is treated with experimental radiation therapy based on protons
Radiation: Proton versus photon radiation therapy
The intervention is proton radiation therapy versus photon radiation therapy
Radiation associated ischaemic and valvular heart disease
The following incidences heart diseases according to ICD10: ischaemic heart disease codes I20-25 and valvular heart disease codes I00-09, I01.0, I09.2, I34-39
Time frame: 10 years after RT
Radiation associated second cancer
Incidences of second cancer associated with the RT: lung, esophagus, thyroid, sarcoma, contralateral breast
Time frame: 10 years after RT
Distant failure
Incidences of distant failures, i.e. cancer recurrence outside the loco-regional region
Time frame: 10 years after RT
Acute radiation associated morbidity
According to CTC version 4.0: Incidences of radiation dermatitis, itching, pain, fatigue, dyspnea, cough, pneumonitis, dysphagia, increased sensation of tightness of the shoulder and lymphedema
Time frame: within 6 months after RT
Late radiation associated morbidity
Incidences of fibrosis, dyspigmentation, telangiectasia, edema, arm lymph edema, range of motion of the shoulder, pain, rib fractures, pneumonitis
Time frame: 10 years after RT
Patient reported outcome measures
Rates of patient satisfaction with cosmetic outcome, body image scale, rates of depression and fear of cancer recurrence
Time frame: 10 years after RT
Translational research
Incidences of cardiac disease detected on heart CT scans, PET CT scans, and concentration of early markers of late cardiac events measured in blood samples
Time frame: 10 years after RT
Plan to share: Yes — The plan is to share data when the primary and secondary endpoints have been published
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will become available, when the primary and secondary endpoints have been published.
Access criteria: The research Group must apply the Danish Breast cancer Group (DBCG) to gain access to the anonymized trial data.
No publications or documents are linked to this record.
Started Jun 2020 (actual). Primary completion is estimated for Jun 2027, 84 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 84 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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Danish Breast Cancer Cooperative Group