Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04291378
Other study ID # DBCG Proton trial
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date June 1, 2037

Study information

Verified date October 2020
Source Danish Breast Cancer Cooperative Group
Contact Birgitte V Offersen, phd
Phone +45 28838012
Email birgoffe@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1502
Est. completion date June 1, 2037
Est. primary completion date June 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Proton versus photon radiation therapy
The intervention is proton radiation therapy versus photon radiation therapy

Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg
Denmark Aarhus University Hospital Aarhus
Denmark Rigshospitalet Copenhagen
Denmark The Danish Breast Cancer Cooperative Group Copenhagen
Denmark Herlev Hospital Herlev
Denmark Naestved Hospital Naestved
Denmark Odense University Hospital Odense
Denmark Vejle Hospital Vejle

Sponsors (1)

Lead Sponsor Collaborator
Danish Breast Cancer Cooperative Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 10 years after RT
Secondary Radiation associated second cancer Incidences of second cancer associated with the RT: lung, esophagus, thyroid, sarcoma, contralateral breast 10 years after RT
Secondary Distant failure Incidences of distant failures, i.e. cancer recurrence outside the loco-regional region 10 years after RT
Secondary 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 within 6 months after RT
Secondary Late radiation associated morbidity Incidences of fibrosis, dyspigmentation, telangiectasia, edema, arm lymph edema, range of motion of the shoulder, pain, rib fractures, pneumonitis 10 years after RT
Secondary Patient reported outcome measures Rates of patient satisfaction with cosmetic outcome, body image scale, rates of depression and fear of cancer recurrence 10 years after RT
Secondary 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 10 years after RT
See also
  Status Clinical Trial Phase
Withdrawn NCT04538833 - GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel Phase 2
Completed NCT04436744 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer) Phase 2
Completed NCT02187744 - A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04) Phase 3
Terminated NCT01155063 - Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients N/A
Recruiting NCT03949634 - Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin(PLD) Phase 3
Active, not recruiting NCT05730647 - Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
Terminated NCT01919229 - A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1) Phase 2
Active, not recruiting NCT04293393 - Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients Phase 2
Completed NCT00713141 - Evaluation of Brain Function Before and After Standard Chemotherapy for Early Breast Cancer N/A
Recruiting NCT06341894 - Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer Phase 2
Not yet recruiting NCT06404736 - QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer Phase 2
Not yet recruiting NCT06404463 - QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer Phase 2
Not yet recruiting NCT06435104 - Aromatherapy in the Treatment of Early Breast Cancer Phase 2
Recruiting NCT03520894 - Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer N/A
Completed NCT03786198 - Activity Program During Aromatase Inhibitor Therapy N/A
Completed NCT01613352 - Feasibility of Ambulatory Surgery for Early Breast Cancer N/A
Completed NCT02738970 - A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC) Phase 1
Recruiting NCT01792726 - A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer. N/A
Completed NCT00323479 - Arthralgia During Anastrozole Therapy for Breast Cancer Phase 4
Completed NCT03493854 - A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer Phase 3