[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dcis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dcis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,75,106,140,176,206,233,256,287,307],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100423701","prospective-evaluation-of-breast-conserving-surgery-alone-in-low-risk-ductal-carcinoma-in-situ-dcis-100423701",false,"NCT04797299","Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)","Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ Defined by a Molecular Expression Assay Combined With Clinico-Pathological Features","ELISA","Inclusion Criteria:\n\n1. Female patient \\> 45 years of age with DCIS without microinvasion.\n2. Tumour size ≤ 2.5cm.\n3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\\*\n\n   \\* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.\n4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.\n\nExclusion Criteria:\n\n1. Multifocal DCIS.\n2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.\n3. Synchronous or previous invasive or non-invasive breast cancer.\n4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.\n5. ECOG performance status ≥3.\n6. Life expectancy \\\u003C10 years.\n7. Geographic inaccessibility for follow-up.","FEMALE","46 Years",{"count":20,"type":21},526,"ESTIMATED","OBSERVATIONAL","To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)",[25],"DCIS",[27,28,29],"Ductal Carcinoma in Situ","Breast Conserving Surgery","Oncotype DX DS","RECRUITING","2026-06-15",{"date":33,"type":34},"2026-06-17","ACTUAL",{"date":36,"type":34},"2022-11-23",{"date":38,"type":21},"2035-11-30",{"name":40,"class":41},"Ontario Clinical Oncology Group (OCOG)","OTHER",24,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100357625","phase-2-real-time-mri-guided-3-fraction-accelerated-partial-breast-irradiation-in-early-breast-cancer-100357625","NCT03936478","Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer","A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)","MAPBI","Inclusion Criteria:\n\nFor all participants\n\n* Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.\n* Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.\n* Pregnancy test negative in women of child bearing potential (WOCBP).\n* The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.\n* Participants with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior and are deemed by their physician to be at low risk for recurrence. Participants with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.\n\nFor participants with Invasive Carcinoma\n\n* Suitable:\n\n  * Age: \\>=50 years\n\n    * Margins: Negative by at least 2 mm\n    * T Stage: Tis or T1\n* Cautionary:\n\n  * Age: 40-49 years\n\n    * Margins: Negative by at least 2 mm\n    * T Stage: Tis or T1 OR\n  * Age: \\>=50 years IF participant has at least 1 of the pathologic factors below and does not have any \"unsuitable\" factors (below)\n\n    * Pathologic Factors:\n\n      * Size 2.1-3.0 cm (size of the invasive component)\n      * T2\n      * Close margins (\\\u003C2 mm)\n      * Limited\u002Ffocal Lymphovascular Space Invasion (LVSI)\n      * ER (-)\n      * Clinically unifocal with total size 2.1-3.0 cm (Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography\u002Fmammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm).\n      * Invasive lobular histology\n      * Extensive Intraductal Component (EIC) \\\u003C=3 cm\n\nFor participants with DCIS\n\n* Suitable Criteria, DCIS allowed if all of the following are met:\n\n  * Screen-detected\n  * Low to intermediate nuclear grade\n  * Size \\\u003C=2.5 cm\n  * Resected with margins negative at \\>=3mm OR\n* Cautionary Criteria:\n\n  * Pure DCIS \\\u003C=3 cm if \"suitable\" criteria not fully met\n\nExclusion Criteria (unsuitable criteria) :\n\n* Men are not eligible for this study.\n* BRCA1\u002F2 mutation positivity.\n* Age \\\u003C 40 years (American Society for Radiation Oncology (ASTRO) Unsuitable Criteria).\n* Positive resection margins on post operative pathology(ASTRO Unsuitable Criteria).\n* Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.\n* Suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.\n* Non-epithelial breast malignancies such as sarcoma or lymphoma.\n* Proven multicentric carcinoma (invasive cancer or DCIS) (ASTRO Unsuitable Criteria).\n* Pure DCIS \\>3 cm in size (ASTRO Unsuitable Criteria).\n* Presence of extensive intraductal component \\>30mm (ASTRO Unsuitable Criteria).\n* Paget's disease of the nipple.\n* History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Participants with a history of LCIS treated by surgery alone are eligible.)\n* Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.\n* Concurrent therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, Aromatase Inhibitors or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention or neoadjuvant therapy.\n* Breast implants.\n* Prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation.\n* Collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.\n* Pregnancy or lactation at the time of treatment. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.\n* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements.","40 Years",{"count":53,"type":21},30,"INTERVENTIONAL",[56],"PHASE2","This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.",[59,25,60],"Breast Cancer","LCIS",[62,63,64],"cosmesis","cosmetic","breast-conserving therapy","2026-06-09",{"date":67,"type":34},"2026-06-11",{"date":69,"type":34},"2022-05-16",{"date":71,"type":21},"2031-01",{"name":73,"class":41},"University of Wisconsin, Madison",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":53},"100320216","the-predict-registry-100320216","NCT03448926","The PREDICT Registry:","A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy","Inclusion criteria\n\n1. Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).\n2. Patient must have the DCISionRT test ordered during routine patient care.\n3. Patient must be eligible for or have recently completed breast conserving surgery.\n4. Patient must be eligible to receive radiation and\u002For systemic treatment.\n5. Patient must be 30 to 85 years old.\n6. Patient must have tumor size of less than 6 cm.\n7. Patient must have been diagnosed with DCIS within 120 days of consent.\n\nExclusion criteria\n\n1. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.\n2. Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.\n3. Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.\n4. Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.\n5. Patient has a prior history of in-field radiation in the ipsilateral breast.\n6. Patient has had prior systemic endocrine or chemotherapy prior to testing.\n7. Patient is pregnant.","30 Years","85 Years",{"count":85,"type":21},3000,"This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.",[25,88,89],"Stage 0 Breast Cancer","Ductal Breast Carcinoma In Situ",[25,91,92,93,94,95],"molecular testing","risk of recurrence","treatment decision","decision impact","predictive","2026-04-14",{"date":98,"type":34},"2026-04-17",{"date":100,"type":34},"2018-02-27",{"date":102,"type":21},"2036-12",{"name":104,"class":105},"PreludeDx","INDUSTRY",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":54,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":74},"100585434","phase-2-ultra-hypo-fractionated-adjuvant-whole-breast-radiation-therapy-with-simultaneous-integrated-boost-for-early-stage-breast-cancer-h-assist-100585434","NCT06902311","Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)","H-ASSIST","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n* Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.\n* Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).\n* Subjects planned to receive either SOC whole breast 3D conformal radiation therapy (3D CRT) or SOC whole breast intensity modulated radiation therapy (IMRT) with standard dose tumor bed boost.\n* Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, per the discretion of the treating radiation oncologist.\n* Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the Principal Investigator.\n\nExclusion Criteria:\n\n* Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).\n* Synchronous bilateral breast cancer requiring bilateral radiation therapy.\n* Clinical or imaging evidence of distant metastases.\n* Prior ipsilateral breast or thoracic radiation.\n* Autoimmune conditions\n* Collagen Vascular Disease (such as systemic lupus erythematosus, scleroderma, dermatomyositis, among others)\n* Patients with pT4 tumors.\n* Patients recommended to receive regional nodal irradiation with associated radiation risks","50 Years",{"count":115,"type":21},90,[56],"This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy.\n\nThe FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.",[59,119,27,25],"Early-stage Breast Cancer",[121,122,123,124,125,126,127,128,129,130],"whole breast irradiation","WBI","simultaneous integrated tumor bed boost (SIB)","SIB","Concurrent boost","adverse effects","toxicity","Radiation-specific toxicity","patient reported outcome","PRO-CTCAE","2026-03-24",{"date":133,"type":34},"2026-03-30",{"date":135,"type":34},"2025-02-19",{"date":137,"type":21},"2028-02",{"name":139,"class":41},"UNC Lineberger Comprehensive Cancer Center",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":54,"phases":150,"briefSummary":152,"conditions":153,"keywords":160,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":74},"100615410","a-prospective-cohort-study-of-handx---assisted-endoscopic-mastectomy-feasibility-and-safety-athena-i-study-100615410","NCT07292246","A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)","ATHENA I","Inclusion Criteria:\n\n* Female sex\n* Age ≥ 18 years old\n* Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:\n\n  1. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery\n  2. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of partial or complete response\n  3. ductal carcinoma in situ (DCIS), or\n  4. BRCA or other breast cancer - related genetic mutation carriers, or\n  5. high risk for development of breast cancer.\n* Breast volume: cup sizes A to C as defined by underwear size, expected implant volume \\\u003C550cc and glandular ptosis not exceeding Grade I Regnault's classification.\n* ECOG \u002F WHO Performance Status \\\u003C2\n* Subject with signed and dated informed consent form\n\nExclusion Criteria:\n\n* Chest wall or skin invasion\n* Extended lymph node involvement at diagnosis (cN2)\n* Inflammatory breast cancer\n* Tumor distance from nipple - areola complex \\\u003C1cm on imaging studies\n* Active smoking\u002Fnicotine use within 4 weeks pre-op (combustible tobacco, vaping, nicotine pouches, NRT)\n* BMI \\>35\n* High risk patients with severe and poorly controlled co-morbid conditions (including but not limited to diabetes, heart disease, renal failure or liver dysfunction)\n* Pregnancy or breastfeeding\n* Psychiatric, addictive, or any disorders which compromise the ability to give informed consent for participation in this study\n* Subject without signed and dated informed consent form","18 Years",{"count":149,"type":21},15,[151],"NA","This study aims to learn whether a handheld robotic device, called the HandX, can help surgeons safely perform a minimally invasive nipple-sparing mastectomy. This type of mastectomy uses a small incision at the side of the breast to remove breast tissue while keeping the skin and nipple in place. The goal is to lower scarring, improve comfort, and support good cosmetic results after surgery.\n\nParticipants in this study will already be planning to have a therapeutic or preventive mastectomy with immediate implant-based reconstruction. All surgeries are done at Mediterraneo Hospital in Greece.\n\nDuring the operation, surgeons use the HandX device to assist with the endoscopic dissection. Researchers will collect information about how long the surgery takes, whether the planned approach can be completed without switching to open surgery, and whether any surgical complications occur. They will also check healing, infection, and implant-related problems for up to 365 days after surgery. Participants will complete the BREAST-Q questionnaire before surgery and at several times after surgery to share their views on comfort, well-being, and cosmetic outcomes.\n\nAbout 15 participants will take part. The results will help researchers understand whether this approach is practical and safe, and whether it should be studied further in a larger trial.",[59,154,155,156,157,25,158,159],"BRCA 1 Gene Mutation","BRCA 2 Gene Mutation","Hereditary Breast Carcinoma","Breast Neoplasms","Germline Mutation Abnormality","Early Breast Cancer",[161,162,163,164,165,166],"breast cancer","mastectomy","endoscopic","robotic","handx","nipple-sparing mastectomy","2025-12-05",{"date":169,"type":34},"2025-12-18",{"date":171,"type":34},"2025-09-09",{"date":173,"type":21},"2029-10",{"name":175,"class":41},"Vasileios Kalles",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":183,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":54,"phases":186,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100369008","phase-2-study-of-3-day-partial-breast-radiation-therapy-in-women-with-breast-cancer-100369008","NCT04084730","Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer","Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested With a Non-inferiority Assessment of APBI in New Patient Cohorts","Inclusion Criteria:\n\n* Female\n* Age \\>\u002F= 45 years\n* Unicentric pathological stage I (pT1 or T2 pN0\\_M0) invasive ductal breast cancer or DCIS measuring \\\u003C3 cm in longest diameter on pathology and\u002For mammogram that is histologically confirmed. If T2, the tumor must be less than 3cm in longest diameter. Note: Women ≥ 70 years or older with T1 invasive ductal carcinoma who are estrogen- receptor positive (ER+) with clinically negative axillary nodes, and do not undergo surgical lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible. Patients age 50 or older who are clinically node-negative by physical exam and ultrasound and have a primary tumor that is \\\u003C=2 cm and hormone-receptor positive, are also eligible.\n* Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen.\n* ECOG Performance Status of 0 or 1.\n* Negative serum pregnancy test within 14 days prior to study treatment if a woman has child-bearing potential. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year\n* Written informed consent obtained from subject and ability for subject or comply with the requirements of the study\n* Female subjects of childbearing potential should be willing to use 2 methods or birth control or be surgically sterile or abstain from heterosexual activity for the duration of study participation. Should a woman become pregnant while participating on study, she should inform the treating physician immediately.\n\nInclusion Criteria for intermediate risk substudy:\n\n* Post-NAC cohort patients: clinical T1-T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0-N1 (on exam and imaging) with pathological ypT0, ypTis, or ypT1 (\\\u003C=2cm) and ypN0 (any regimen of neoadjuvant chemotherapy agents is allowed)\n\nOR\n\n* Oncotype RS score of 26 or higher\n\nOR\n\n* PAM50 ROR scored as \"HIGH\"\n\nOR\n\n* Presence or LVI (focal, limited or \"not otherwise specified\") in the lumpectomy specimen\n\nOR\n\n* Age 40-49 years (ALL OF THE FOLLOWING MUST BE TRUE : 1) no history of prior benign breast biopsies, 2) no concomitant or prior atypia in either breast, 3) no concomitant or prior LCIS in either breast, 4) no family history of breast cancer in first degree relatives)\n\nOR\n\n* Invasive lobular carcinoma\n\nOR\n\n* Surgical margins less than 1 mm to invasive or in-situ disease.\n\nExclusion Criteria:\n\n* Patients with distant metastasis\n* Patients who are pregnant or breastfeeding\n* Patients with diffuse (\\>1 quadrant or \\>5cm) suspicious microcalcifications or patients with known multicentric OR multifocal disease. (microscopic multifocal disease that may be unifocal and\u002For appear multifocal due to sectioning is allowed after review with PI).\n* Prior radiation therapy to the ipsilateral or contralateral breast or thorax.\n* Histological evidence of extensive lymphovascular invasion (LVI)\n* Histological evidence of extensive intraductal component (EIC), defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumo area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor.\n* Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. Note: in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study. It would be an extremely rare\u002Funlikely scenario for patients to be discovered BRCA positive after the completion of PBI, as all patients with risk factors for BRCA mutations (positive family history, Ashkenazi Jewish descent, ER-\u002FPR-\u002Fher2-neu-negative receptor status) are usually tested prior to radiation. Should such a situation exist, these patients will be given the option of remaining on the breast conservation paradigm or opting for mastectomy (as is done in this rare scenario is standard of care practice). The patient will be replaced on the trial.\n* History of cosmetic or reconstructive breast surgery.\n* Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.\n* Patients with a \"currently active\" second malignancy other than non-melanoma skin cancers. Patients are not considered to have \"currently active\" malignancies if they have completed therapy and are considered by their physicians to be at \\\u003C5% risk of relapse within 3 years.\n* Patients who are already enrolled in or planning to enroll in other adjuvant systemic therapy protocols for both non-invasive or invasive breast cancer\n* Expecting to conceive within the projected duration of the trials, starting with screening visit through 180 days after the last dose of trial treatment\n* Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. Bisphosponates are permitted without restriction even during protocol treatment. Note: This does not apply to hormonal therapies such as tamoxifen or AIs, which are permitted. This does not apply to anti-Her2 therapies such as trastuzumab or TDM-1, which are also permitted.\n* Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.","45 Years",{"count":185,"type":21},280,[56],"The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.",[189,190,25,191,192,59],"Invasive Ductal Breast Carcinoma","Invasive Ductal Carcinoma, Breast","DCIS Grade 1","DCIS Grade 2",[194,59,195,196],"Unicentric pathological stage I breast invasive ductal breast cancer","Memorial Sloan Kettering Cancer Center","19-300","2025-09-15",{"date":199,"type":34},"2025-09-16",{"date":201,"type":34},"2019-08-30",{"date":203,"type":21},"2026-08-30",{"name":195,"class":41},9,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":213,"minAge":4,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":54,"phases":215,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":223,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":74},"100582200","robotic-nipple-sparing-mastectomy-with-immediate-reconstruction-100582200","NCT06860217","Robotic Nipple Sparing Mastectomy with Immediate Reconstruction","Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial","Inclusion Criteria:\n\n* Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers\n* Any age\n* Negative preoperative assessment of nipple-areola complex\n* Absence of skin involvement\n* Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section\n* Breast volume ≤ Bra IV\n* No hard smoking (defined as \\\u003C=20 cigarettes\u002Fday)\n* Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)\n* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n* Patients must be accessible for follow-up\n\nExclusion Criteria:\n\n* Previous thoracic radiation therapy for any reason\n* Inflammatory Breast Cancer\n* Pregnancy\n* Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.\n* Uncompensated Diabetes Mellitus","ALL",{"count":42,"type":21},[151],"Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.",[59,25,218],"BRCA Mutation",[220,221,222],"Robotic Mastectomy","Nipple-sparing mastectomy","Breast reconstruction","NOT_YET_RECRUITING","2025-02-28",{"date":226,"type":34},"2025-03-05",{"date":228,"type":21},"2025-04",{"date":230,"type":21},"2032-04",{"name":232,"class":41},"European Institute of Oncology",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":213,"minAge":240,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":54,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":74},"100509372","delayed-selective-sentinel-node-biopsy-for-patients-undergoing-mastectomy-for-dcis-100509372","NCT05912569","Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS","Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ","Inclusion Criteria:\n\n* Patients aged 20 to 75 years old.\n* Patients diagnosed with DCIS through histological examination.\n* Patients undergoing mastectomy\n\nExclusion Criteria:\n\n* In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions.\n* In cases where imaging tests or physical examinations suggest possible lymph node metastasis.\n* In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure.\n* Pregnant patients.","20 Years","75 Years",{"count":243,"type":21},84,[151],"In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery.\n\nprimary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.\n\naddendum) The previously documented Breast-Conserving Surgery has been corrected to reflect the accurate procedure of Total Mastectomy.",[25],"2025-01-28",{"date":249,"type":34},"2025-01-31",{"date":251,"type":34},"2023-06-13",{"date":253,"type":21},"2025-04-28",{"name":255,"class":41},"Seoul National University Hospital",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":54,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":223,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":74},"100532795","the-added-value-of-contrast-enhanced-mammography-to-standard-mammography-in-assessing-the-extent-of-dcis-100532795","NCT06217458","The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS","The Added Value of Contrast Enhanced Mammography (CEM) to Standard Mammography in Assessing the Extent of Ductal Carcinoma in Situ (DCIS)","CEMinDCIS","Inclusion Criteria:\n\n* Patients with pathohistological diagnosis of ductal in situ carcinoma based on samples obtained by vacuum-assisted breast biopsy (VABB) or ultrasound-guided breast biopsy (CNB)\n* Presented at the meeting of the multidisciplinary breast team of the Clinical Hospital Center in Rijeka\n* Patients who underwent surgery at CHC Rijeka and whose pathohistological diagnosis in the final PH report was pure DCIS or microinvasive breast cancer (DCIS with microinvasion)\n* Patients who agree to participate in the study\n\nExclusion Criteria:\n\n* Patients with contraindications for CEM: renal insufficiency (which is ruled out by presenting creatinine and\u002For eGFR results), iodine allergy, pregnancy\u002Flactation, hyperthyroidism\n* Patients who have undergone a preoperative breast MRI\n* Patients who have both DCIS and invasive carcinoma in the preoperative PH report or the final PH report of the surgical material, with the exception of foci with microinvasion (\\\u003C 1 mm).\n* Patients with ipsilateral DCIS recurrence or with previous ipsilateral breast surgery for invasive cancer.\n* Patients\u002Fsubjects whose CEMs do not correspond to the diagnostic interpretation for technical reasons are excluded from the study: insufficient positioning, contrast agent extravasation, failed subtraction\n* Patients under 18 years of age","99 Years",{"count":266,"type":21},100,[151],"The study hypothesis is that the rate of inadequate surgical margins after conservative breast surgery for DICS and the rate of reoperation (re-excision or\u002Fand mastectomy) is lower in the group of patients who underwent standard preoperative mammography and CEM to assess the extent of DICS, compared to the group of patients for whom the preoperative assessment of the extent of in situ breast cancer was not performed using one of the imaging techniques with contrast medium such as contrast mammography or magnetic resonance imaging.",[25,270,271],"Breast Carcinoma in Situ","Calcification",[273,274,275,276,277],"Ductal in situ carcinoma","Calcifications","Breast surgery","Screening","Contrast Enhanced Mammography","2025-01-03",{"date":280,"type":34},"2025-01-06",{"date":282,"type":21},"2025-03-01",{"date":284,"type":21},"2027-01-01",{"name":286,"class":41},"Clinical Hospital Center Rijeka",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":54,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":74},"100366280","perioperative-mindfulness-proposal-100366280","NCT04049214","Perioperative Mindfulness Proposal","Feasibility Study to Determine the Effect of Meditation on Perioperative Pain and Distress in Newly Diagnosed Breast Cancer Patients","Inclusion Criteria:\n\n* Females 18 years of age or older\n* Subject must be able to speak and read English\n* Newly diagnosed with primary breast cancer\n* Will receive primary surgical treatment for their breast cancer diagnosis.\n* Undergoing lumpectomy with or without autologous reconstruction with or without contralateral surgery for symmetry with or without IORT or simple mastectomy without reconstruction\n* Breast cancer or DCIS\n\nExclusion Criteria:\n\n* Recurrent breast cancer\n* Current or history of major psychiatric diagnosis.\n* Subjects who are receiving neo-adjuvant chemotherapy\n* Subjects undergoing modified radical mastectomy or reconstruction\n* Subjects regular meditation practice within the past 12 months (defined as greater than twice weekly practice)\n* Subjects unwilling or unable to complete study materials or comply with study visits\n* Subjects with no access to email or a mobile phone (required to access meditations)\n* Subjects undergoing surgery outside Hoag\n* Subjects who have narcotic dependence as defined by regular weekly narcotic use before cancer diagnosis.\n* Re-excision after lumpectomy (subjects who require re-excision after initial enrollment will be excluded from final analysis and dropped from the study).",{"count":42,"type":21},[151],"The purpose of this study is to determine if a regular meditation and breath work practice started before surgery and continued through post-surgical recovery can improve anxiety and pain related to breast cancer and its treatment.",[59,25],"2024-10-09",{"date":300,"type":34},"2024-10-15",{"date":302,"type":34},"2019-07-31",{"date":304,"type":21},"2025-07-31",{"name":306,"class":41},"Hoag Memorial Hospital Presbyterian",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":54,"phases":317,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":205},"100417975","phase-3-delayed-sentinel-lymph-node-biopsy-in-ductal-cancer-in-situ-100417975","NCT04722692","Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ","Sentinel Lymph Node Biopsy in Ductal Cancer in Situ or Unclear Lesions of the Breast and How to Not do it. An Open-label, Phase 3, Randomised Controlled Trial. (SentiNot 2.0).","SENTINOT_2","Inclusion Criteria:\n\nA. Preoperative diagnosis of DCIS, of any grade and any size if planned for mastectomy.\n\nB. Planned Risk-reducing mastectomy, if it would be considered for upfront SLND due to institutional practice or in case of an individualised recommendation.\n\nC. Any case with a preoperative diagnosis of pre-invasive or unclear lesion, that upfront SLND would be otherwise considered, such as, but not limited to:\n\n* Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than or equal to 20 mm on mammography and planned for breast conserving surgery or\n* Patients with a preoperative diagnosis of DCIS on core biopsy with a palpable mass on clinical examination or mass effect on radiology or\n* Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy or\n* Patients with a mammographic\u002Fultrasound\u002FMRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer or\n* Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a complex oncoplastic procedure or\n* Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a procedure that may compromise detection rate for a future SLND, such as, but not confined to: lesions in the upper outer quadrant or the axillary tail, removal of the nipple areola complex and so on or\n* The above mentioned categories with a preoperative diagnosis of pleomorphic Lobular Cancer in Situ (pLCIS), classic Lobular Neoplasia (LN) or Atypical Ductal Hyperplasia (ADH).\n\nExclusion Criteria:\n\n* Intolerance\u002Fhypersensitivity to iron, dextran compounds or SPIO\n* An iron overload disease\n* Patient deprived of liberty or under guardianship\n* Pregnant or lactating patients",{"count":316,"type":21},500,[318],"PHASE3","The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed.",[25,59,157,321],"Sentinel Lymph Node",[323,324,325,326,321,327],"Sentinel Lymph Node Dissection","DCIS; Ductal Cancer In situ of the breast","Breast cancer","Superparamagnetic Iron Oxide Nanoparticles","Risk reducing mastectomy","2023-08-02",{"date":330,"type":34},"2023-08-03",{"date":332,"type":34},"2020-03-01",{"date":334,"type":21},"2027-12-30",{"name":336,"class":41},"Uppsala University"]