[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Danish Breast Cancer Cooperative Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100341848","delayed-immediate-versus-delayed-breast-reconstruction-in-breast-cancer-patients-with-mastectomy-and-radiation-therapy-100341848",false,"NCT03730922","Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy","The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial","Inclusion Criteria:\n\n* Woman \\>18 years who are offered a mastectomy for invasive breast can-cer pT1-3, pN0-N3, M0 and wish reconstruction. The patient can be inclu-ded no matter the status of estrogen receptor, progesterone receptor, malignancy grade, and HER2 status.\n* The patient is a candidate for loco-regional radiation therapy according to national or institutional guidelines.\n* Highly selected patients with inflammatory breast cancer, namely those with complete or near complete response to neoadjuvant systemic thera-py judged by imaging and clinical examination before surgery. Any skin edema and clinical signs of skin involvement must have disappeared during systemic therapy. It is highly recommended that the decision to offer an inflammatory breast cancer patient inclusion in the DBCG RT Recon trial is made during a multidisciplinary team conference.\n* Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatment and other targeted therapies used in the adjuvant setting either as new standard or as part of a trial during the course of the trial is accepted.\n* Neoadjuvant chemotherapy and primary systemic therapy of an operable breast cancer is accepted.\n* Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist esti-mates a low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situ coli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinoma of the skin.\n* Life expectancy minimum 10 years.\n\nExclusion Criteria:\n\n* Pregnant or lactating.\n* Previous breast cancer or Ductal carcinoma in Situ (DCIS).\n* Bilateral breast cancer.\n* Previous radiation therapy to the chest region.\n* Previous non-breast malignancy (not including carcinoma in situ of the cervix or colon, melanoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin) within 5 years.\n* Conditions indicating that the patient cannot go through breast reconstruction, the radiation therapy or follow up.\n* Not being able to participate due to language or other personal issues.\n* Life expectancy less than 10 years.","FEMALE","18 Years",{"count":19,"type":20},590,"ESTIMATED","INTERVENTIONAL",[23],"NA","In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.",[26,27,28],"Breast Neoplasm Female","Complication of Radiation Therapy","Breast Implant; Complications",[30,31,32],"Breast cancer","Reconstruction","Post mastectomy radiotherapy","RECRUITING","2025-02-04",{"date":36,"type":37},"2025-02-06","ACTUAL",{"date":39,"type":37},"2020-01-01",{"date":41,"type":20},"2035-11",{"name":43,"class":44},"Danish Breast Cancer Cooperative Group","OTHER",8,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100384874","the-dbcg-proton-trial-photon-versus-proton-radiation-therapy-for-early-breast-cancer-100384874","NCT04291378","The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer","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","Inclusion Criteria:\n\n* Patient operated for early breast cancer with indication for radiation therapy, where standard planning shows a mean heart dose 4 Gy or more and\u002For a V20 lung of 37% or more.\n* 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\n* 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.\n* Life expectancy minimum 10 years\n\nExclusion Criteria:\n\n* previous breast cancer\u002Fductal carcinoma in situ,\n* Previous RT to the chest region\n* Pregnant or lactating\n* Conditions indicating that the patient cannot go through the RT or follow up\n* Patients with Pacemaker or defibrillator are excluded until a guideline for handling them has been developed at the DCPT\n* 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.\n* Metal implants in the radiation area, including metal in implants.","ALL",{"count":55,"type":20},1502,[23],"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.",[59,60],"Early Breast Cancer","Radiation Associated Cardiac Failure","2020-10-05",{"date":63,"type":37},"2020-10-08",{"date":65,"type":37},"2020-06-01",{"date":67,"type":20},"2037-06-01",{"name":43,"class":44},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100335402","partial-breast-versus-no-irradiation-for-women-with-early-breast-cancer-100335402","NCT03646955","Partial Breast Versus no Irradiation for Women With Early Breast Cancer","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","Inclusion Criteria:\n\nFemale patient \\>=60 years\n\nPrimary tumour characteristics by conventional histopathology\n\n* unilateral and unifocal non-lobular histology grade 1-2\n* maximum microscopic size \\\u003C=20mm\n* node negative determined by sentinel node or axillary lymph node dissection\n* estrogen receptor \\>=10% positive\n* HER2 negative (by IHC and\u002For in situ hybridization)\n* resection margin \\>=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer\n\nSurgical type is breast conservation\n\nPerformance status ECOG 0-2\n\nNo evidence of distant metastasis\n\nExclusion Criteria:\n\n* multifocal or multicentric invasive carcinoma or ductal carcinoma in situ\n* evidence of clinical or pathological T4 breast cancer\n* grade 3 malignancy\n* previous breast cancer or DCIS irrespective of disease-free interval\n* previous radiation therapy to the breast or thorax,\n* previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.\n* comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).\n* mental\u002Fpsychiatric disorder which precludes the patient from understanding the randomization and the follow up.\n* documented hereditary breast cancer or with high genetic risk of breast cancer\n* life expectancy \\\u003C10 years","60 Years",{"count":78,"type":20},926,[23],"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.",[82,83,84,85,86,87,88,89,90],"Local Neoplasm Recurrence","Distantly Metastatic Malignant Neoplasm","Death","Fibrosis Breast","Depigmentation\u002FHyperpigmentation of Skin","Telangiectasia","Scar","Pain","PROMs",{"date":92,"type":37},"2020-10-06",{"date":94,"type":37},"2018-09-05",{"date":96,"type":20},"2035-09-01",{"name":43,"class":44},17,""]