Early Breast CancerNCT04291378
The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
A study testing Proton versus photon radiation therapy in people with Early Breast Cancer and Radiation Associated Cardiac Failure, run by Danish Breast Cancer Cooperative Group at 8 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Breast Cancer, Radiation Associated Cardiac Failure
- What is being tested?
- Proton versus photon radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,502 participants
- Where
- 8 sitesDenmark
- Study dates
- 1 Jun 2020to 1 Jun 2037
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient operated for early breast cancer with indication for radiation therapy, where standard planning shows a mean heart dose 4 Gy or more and/or a V20 lung of 37% or more.
- Boost (breast, chest wall and nodal), breast reconstruction (any type, except implants with metal), connective tissue disease, post-operative surgical complications, any breast size and seromas are allowed
- Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist estimates a low risk of recurrence.
- Life expectancy minimum 10 years
Who cannot join
- previous breast cancer/ductal carcinoma in situ,
- Previous RT to the chest region
- Pregnant or lactating
- Conditions indicating that the patient cannot go through the RT or follow up
- Patients with Pacemaker or defibrillator are excluded until a guideline for handling them has been developed at the DCPT
- Unknown non-tissue implants upstream of the target volume. NB. all such non-tissue, non-metal objects must be delivered to the DCPT for stopping power determination and evaluation at least a week prior to radiation start.
- Metal implants in the radiation area, including metal in implants.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Denmark8 sites, 8 recruiting
- Recruiting
Aalborg University Hospital
Aalborg
Lars Stenbygaard, MD
- Recruiting
Aarhus University Hospital
Aarhus
Hanne M Nielsen, PhD
- Not yet recruiting
The Danish Breast Cancer Cooperative Group
Copenhagen, DK-2100 Ø
Birgitte Offersen, MD, phd
Birgitte Offersen, MD, phd
- Recruiting
Rigshospitalet
Copenhagen
Claus Kamby, DMSc
- Recruiting
Herlev Hospital
Herlev
Susanne Vallentin
- Recruiting
Naestved Hospital
Næstved
Sami Al-Rawi, MD
- Recruiting
Odense University Hospital
Odense
Mette H Nielsen, PhD
- Recruiting
Vejle Hospital
Vejle
Troels Bechmann, PhD
About this study
Official title: The DBCG Proton Trial. Adjuvant Breast Proton Radiation Therapy for Early Breast Cancer Patients: The Skagen Trial 2, a Clinically Controlled Randomised Phase III Trial
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.
Read the detailed description
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.
- Being tested
- Proton versus photon radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton versus photon radiation therapyRadiation
The intervention is proton radiation therapy versus photon radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Photon radiation therapy | Active comparator | The patient is treated with standard radiation therapy based on photons Receives: Radiation: Proton versus photon radiation therapy |
| Proton radiation therapy | Experimental | The patient is treated with experimental radiation therapy based on protons Receives: Radiation: Proton versus photon radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years after RT
Secondary outcomes (6)
Radiation associated second cancer
Incidences of second cancer associated with the RT: lung, esophagus, thyroid, sarcoma, contralateral breast
Measured: 10 years after RT
Distant failure
Incidences of distant failures, i.e. cancer recurrence outside the loco-regional region
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 years after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomised between 2 arms with different types of radiation therapy, and patients in both arms have similar follow up
- Masking
- None (open label)
- Enrolment
- 1,502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Breast Cancer Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgitte Offersen, Danish Breast Cancer Cooperative Group
- Investigators
- Birgitte V Offersen, phd, Principal investigator, Danish Breast cancer Cooperation Group (DBCG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291378
- Sponsor's protocol ID
- DBCG Proton trial
- Status last verified
- Oct 2020
- First submitted
- 24 Feb 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The plan is to share data when the primary and secondary endpoints have been published