[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ductal-carcinoma-in-situ\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ductal-carcinoma-in-situ":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,73,114,137,171,195,221,247,272,295,318,338,362],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100582817","phase-2-evaluation-of-novel-iron-based-lymphatic-mapping-agent-magtrace-for-delayed-sentinel-lymph-node-biopsy-slnb-in-ductal-carcinoma-in-situ-dcis-100582817",false,"NCT06868238","Evaluation of Novel Iron-based Lymphatic Mapping Agent, Magtrace, for Delayed Sentinel Lymph Node Biopsy (SLNB) in Ductal Carcinoma In-Situ (DCIS)","Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* Patients with a core needle biopsy diagnosis consistent with ductal carcinoma in-situ (DCIS), Stage 0 breast cancer, who are planning to undergo a mastectomy.\n\n  o The mastectomy can be with or without reconstruction and with or without contralateral prophylactic mastectomy.\n* Patients with a negative pre-operative axillary ultrasound.\n* For subjects of childbearing potential, a pregnancy test that has resulted as negative is required preoperatively.\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.\n\nExclusion Criteria:\n\n* Patients with contralateral invasive breast cancer requiring traditional sentinel lymph node biopsy at time of index operation or additional chemotherapy that may have been omitted for DCIS.\n* Any history of receiving chemotherapy\n* Prior ipsilateral breast cancer with treatment that included radiation, lumpectomy, chemotherapy, or sentinel lymph node biopsy.\n* Ipsilateral prior axillary sentinel lymph node biopsy for other malignancy (i.e., melanoma).\n* Patients with a history of upper extremity blood clot, lymphangitis\u002Fcellulitis, lymphedema, or those who use a pacemaker device\n* Patients with an allergy to iron, dextran, or any other ingredient in Magtrace.\n* Patients with an abnormal pre-operative axillary ultrasound.\n* Subjects who are confirmed to be pregnant.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","The standard surgical approach for all patients undergoing mastectomy for the treatment of non-invasive, ductal carcinoma in situ (DCIS) is to perform axillary lymph node staging through use of a traditional sentinel lymph node biopsy (SLNB) procedure where the lymph nodes that drain the breast first are removed at the time of mastectomy. This recommendation for traditional SLNB is due to the risk of finding invasive cancer during surgical evaluation of the mastectomy specimen and the inability to accurately map the lymphatic channels once the breast is removed.\n\nIn a study by Herremans et al, the majority of traditional SLNBs were demonstrated to be unnecessary. By using Magtrace, a novel iron based lymphatic mapping agent, a delayed SLNB could eliminate these unnecessary traditional SLNBs.\n\nMagtrace, or superparamagnetic oxide (SPIO), was developed in 2018. Unlike traditional mapping agents of blue dye and technetium that clear the body within 24-48 hours, Magtrace remains in the lymph nodes for at least 4 weeks. Magtrace's ability to remain in the lymph node allows accurate mapping of the lymph nodes at the time of the mastectomy with the ability to return to the operating room for a delayed sentinel lymph node biopsy if invasive cancer is found on final pathology.\n\nThis study will investigate whether the use of Magtrace will successfully allow patients with DCIS undergoing mastectomy to avoid undergoing SLNB.",[25],"Ductal Carcinoma in Situ",[27,28,29,30,31,32],"ductal carcinoma in situ","superparamagnetic oxide (SPIO\u002FMagtrace)","sentinel lymph node biopsy","mastectomy","breast","lymphedema","RECRUITING","2026-06-04",{"date":36,"type":37},"2026-06-08","ACTUAL",{"date":39,"type":19},"2026-08",{"date":41,"type":19},"2029-06",{"name":43,"class":44},"University of Florida","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100521927","phase-2-dcis-recast-trial-ductal-carcinoma-in-situ-re-evaluating-conditions-for-active-surveillance-suitability-as-treatment-100521927","NCT06075953","DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment","DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study","Inclusion Criteria:\n\nA. Female, at least 18 years old\n\nB. Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion\n\n* Patients with a diagnosis of hormone positive DCIS who have undergone surgery with positive margins that have not been re-excised are candidates to enroll in the trial.\n\nC. Patients who have previously received endocrine therapy should have a washout period of at minimum 4-6 weeks prior to the screening MRI on the RECAST-DCIS trial\n\nD. Bilateral mammogram performed within up to 6 months (180 days) of the start of trial treatment may be used for screening evaluation. If a bilateral mammogram has been performed within 1 year (12 months) of the start of trial treatment, then a diagnostic unilateral mammogram within 6 months (180 days) of the start of trial treatment will be acceptable for screening evaluation.\n\nE. MRI performed on an I SPY (RECAST) approved scanner within 2 months (60 days) of the start of trial treatment for lesion evaluation may be used for screening evaluation.\n\nF. CBC w\u002F diff, CMP, and Lipid Panel within normal limits within a year of the start of trial treatment. Abnormal labs to be repeated within 60 days prior to the start of trial treatment. Patients will be considered eligible for screening labs that are abnormal or out-of-range if the investigator has deemed the lab results not-clinically significant\n\nG. Negative urine or serum pregnancy test within 1 month of the start of trial treatment\n\nH. Controlled HIV positive patients are allowed as long as their current medication does not contraindicate the study's investigational agent\n\nI. Willingness and ability to provide tumor samples for research\n\nExclusion Criteria:\n\nA. Pregnant or actively breastfeeding women\n\nB. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history\n\nC. Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer\n\nD. Co-enrollment in clinical trials of pharmacologic agents requiring an IND\n\nE. Ongoing treatment for DCIS other than what is specified in this protocol\n\nF. Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements\n\nG. Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and\u002For tamoxifen. Active inflammatory bowel disease or chronic diarrhea, known active hepatitis A\u002FB\u002FC\\*, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures\n\n\\*Active hepatitis, defined as: A (positive HA antigen or positive IgM); B (either positive HBs antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay); C (positive hepatitis C antibody result, and quantitative hepatitis C (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay)\n\nH. Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment","FEMALE",{"count":55,"type":19},400,[22],"The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease.\n\nParticipants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.",[25],[60,61,62],"active surveillance","hormone therapy","endocrine therapy","2026-05-19",{"date":65,"type":37},"2026-05-22",{"date":67,"type":37},"2024-02-17",{"date":69,"type":19},"2033-11",{"name":71,"class":44},"QuantumLeap Healthcare Collaborative",28,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":20,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":45},"100633498","hismar-intraoperative-margin-assessment-using-the-histolog-scanner-to-reduce-reoperation-in-breast-conserving-surgery-100633498","NCT07527468","HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery","HISMAR: A Prospective Post-Market Performance Follow-up Study of the Histolog Scanner for Intraoperative Margin Assessment in Breast-Conserving Surgery for High-Risk Histological Subtypes (ILC, DCIS, NST+DCIS)","HISMAR","1. Female patient, aged 18 years or older at time of surgery.\n2. Pre-operative core needle biopsy (CNB) or vacuum-assisted biopsy (VAB) with histological diagnosis of one of the following:\n\n   1. invasive lobular carcinoma (ILC\u002FCLI),\n   2. pure ductal carcinoma in situ (DCIS), or\n   3. invasive carcinoma of non-special type (NST) with an associated DCIS component.\n3. Planned breast-conserving surgery (BCS \u002F lumpectomy) at CHVR.\n4. Signed electronic informed consent (eIC) obtained prior to any study procedure.\n\nExclusion Criteria:\n\n1. Pregnancy (confirmed or suspected) at time of surgery.\n2. Prior neo-adjuvant treatment (hormonal therapy or chemotherapy) for the current breast cancer diagnosis.\n3. Surgical indication for mastectomy rather than BCS.\n4. Known hypersensitivity or allergy to acriflavine (fluorescent staining agent used with the Histolog Scanner).\n5. Incapacity to provide informed consent.\n6. Previous enrolment in this study.",{"count":82,"type":19},228,[84],"NA","This study evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS).\n\nAfter lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing.\n\nBased on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.",[87,88,89,90],"Breast Cancer","Ductal Carcinoma In Situ","Invasive Lobular Carcinoma","Breast Neoplasm Female",[92,93,94,95,96,97,98,99,100,101,102,103],"breast-conserving surgery","lumpectomy","surgical margins","intraoperative imaging","confocal microscopy","reoperation","re-excision","histological scanning","DCIS","ILC","post-market performance follow-up","PMPF","NOT_YET_RECRUITING","2026-04-07",{"date":107,"type":37},"2026-04-14",{"date":109,"type":19},"2026-09-01",{"date":111,"type":19},"2030-06-01",{"name":113,"class":44},"Hôpital du Valais",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":20,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":45},"100624378","phase-1-can1012-in-pre-malignant-dcis-and-lcis-100624378","NCT07408856","CAN1012 in Pre-Malignant DCIS and LCIS","A Phase I\u002FIb Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Ductal Carcinoma in Situ and Lobular Carcinoma in Situ","Inclusion Criteria:\n\n1. Male or female patients with DCIS or LCIS found on core biopsy.\n2. Tumor types allowed:\n\n   Biopsy-identified DCIS or LCIS comprising a single lesion ≥ 1 cm and ≤ 5 cm in size by imaging (mammogram or MRI or ultrasound (US)) without evidence of invasive disease on the biopsy and US negative for suspicious ipsilateral lymph nodes.\n3. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.\n5. Laboratory values within 72 hours of Day 0:\n\n   1. WBC ≥ 2.0 K\u002FµL, ANC ≥ 1.0 K\u002FµL\n   2. Hgb ≥ 10 g\u002FdL\n   3. Platelets ≥ 100,000 K\u002FµL\n   4. Creatinine Clearance (using Cockcroft-Gault) ≥ 60.\n   5. AST\u002FALT ≤ 2.5 x ULN\n   6. Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg\u002FdL)\n   7. Negative pregnancy test for people of childbearing potential (bHCG urine or serum)\n6. Patients and their partners who are capable of conceiving must agree to use effective methods of contraception (non-hormonal only) during the course of treatment and for 165 days after last dose of CAN1012.\n\nExclusion Criteria:\n\n1. Any serious underlying medical or psychiatric condition that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study procedures, completion, or evaluation.\n2. Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.\n3. Need for hormonal contraception including oral contraceptives, implant, injectable depots, vaginal rings, skin patches, and the progestin IUD; or any medication that is a sensitive substrate of the major CYPs.\n4. History of or current active autoimmune diseases which, in the judgment of the investigator, pose an active and significant risk. Vitiligo, lichen planus or lichenoid inflammation, and adequately controlled endocrine deficiencies such as hypothyroidism\u002Fhyperthyroidism are not exclusionary.\n5. Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).\n6. Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.\n7. Has active or uncontrolled Hepatitis B, Hepatitis C, or HIV with AIDS (acquired immunodeficiency syndrome)- defined opportunistic infection.\n8. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known history of Hepatitis C virus (defined as HCV RNA) infection. Testing for Hepatitis B and Hepatitis C is not required unless mandated by local health authority.\n9. Has a baseline electrocardiogram (ECG) with a prolonged QTc interval \\> 480 msec. Medications which have a known and clinically significant risk of QT prolongation may be allowed per investigator discretion.\n10. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.",{"count":122,"type":19},24,[124],"PHASE1","This is a Phase I\u002FIb study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ.",[25,127],"Lobular Carcinoma in Situ","2026-04-02",{"date":130,"type":37},"2026-04-08",{"date":132,"type":19},"2026-05",{"date":134,"type":19},"2035-05",{"name":136,"class":44},"Providence Health & Services",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":53,"minAge":144,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":20,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":45},"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":146,"type":19},90,[22],"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.",[87,150,25,100],"Early-stage Breast Cancer",[152,153,154,155,156,157,158,159,160,161],"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":164,"type":37},"2026-03-30",{"date":166,"type":37},"2025-02-19",{"date":168,"type":19},"2028-02",{"name":170,"class":44},"UNC Lineberger Comprehensive Cancer Center",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":45},"100630774","breast-tumour-size-measurement-by-field-cycling-imaging-100630774","NCT07492043","Breast Tumour Size Measurement by Field Cycling Imaging","BREVIA","Inclusion Criteria:\n\n* Females ≥ 18 years old.\n* Subjects diagnosed with DCIS on initial biopsy.\n* Lesion size \\>1 cm on imaging.\n* Subjects undergoing surgery as part of their treatment.\n* Able to fit comfortably in the scanners.\n* Able to understand written and spoken English.\n\nExclusion Criteria:\n\n* Subjects undergoing chemotherapy or hormonal therapy.\n* Individuals unable to give informed consent.\n* Contra-indications to MRI scanning such as implantable cardiac devices.\n* Known allergy to contrast agent.",{"count":179,"type":19},12,"OBSERVATIONAL","The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can accurately estimate tumour size in patients with a type of breast cancer called ductal carcinoma in situ (DCIS). The main question it aims to answer is:\n\nCan FCI accurately estimate DCIS lesion size compared with histology results?\n\nParticipants will have a standard MRI scan and an FCI scan before undergoing surgery to remove the tumour.",[87,88],[184,185,100,87],"Field-Cycling Imaging","FCI","2026-03-19",{"date":188,"type":37},"2026-03-25",{"date":190,"type":19},"2026-04",{"date":192,"type":19},"2026-12",{"name":194,"class":44},"University of Aberdeen",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":45},"100629695","exploring-inflammation-and-social-determinants-study-in-breast-cancer-patients-100629695","NCT07478016","EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients","EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients","EXIST","Inclusion Criteria:\n\n* Individuals must meet all the following inclusion criteria to be eligible to participate in the study:\n\n  1. Female\n  2. \\>18 years old at time of consent\n  3. Biopsy proven invasive breast cancer or ductal carcinoma in situ\n  4. Candidate has not yet received cancer therapy for their breast cancer diagnosis\n  5. ECOG Performance Status \\\u003C 2\n  6. Able to provide consent\n  7. Must be English speaking\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Patient has started therapy or already had definitive oncologic surgery\n  2. Another malignancy within the past 6 months that was not a non-melanomatous skin lesion",{"count":204,"type":19},200,"This is a pilot trial to assess how measures of inflammation are correlated with Social Determinants of Health (SDoH) in breast cancer patients. Expected duration of subject participation is one single time point. The patients will fill out questionnaires and provide a plasma sample.",[87,88],[208,209,210,211],"Social Determinants of Health","IL-6","cytokine profile","immune marker profile","2026-03-13",{"date":214,"type":37},"2026-03-17",{"date":216,"type":37},"2022-12-21",{"date":218,"type":19},"2028-12-31",{"name":220,"class":44},"Thomas Jefferson University",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":20,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":45},"100532860","phase-1-prototype-daataa-vaccine-targeting-muc1-for-immune-interception-and-prevention-in-ductal-carcinoma-in-situ-100532860","NCT06218303","Prototype DAA\u002FTAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ","A Clinical Study of a Prototype DAA\u002FTAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ","Inclusion Criteria:\n\n1. Females, 18 years of age or older. Pre-menopausal women must use an effective method of contraception during the study.\n2. Capable of providing informed consent and willing to comply with study procedures\n3. Biopsy-proven ER+ DCIS\n\n   * The signed pathology report from the attending pathologist will be used to determine eligibility\n   * Sufficient amount of DCIS remaining in the diagnostic core biopsy block(s) and available for research\n   * Patients with DCIS suspicious for microinvasion on core biopsy will be eligible because many of these patients will not have invasion on final pathology\n   * Women presenting with concurrent bilateral DCIS are eligible only if both the right and left DCIS lesions are ER+, and tissue from both sides will be analyzed and must meet the criteria below\n4. DCIS must be ≥ 1cm based on the extent of calcifications on mammogram, the presence of a mass on ultrasound or enhancement on MRI OR DCIS ≥ 5mm on one single core by pathologic evaluation OR DCIS \\\u003C 5mm if identified in ≥ 2 cores\n5. Candidate for selective estrogen receptor modulator or aromatase inhibitor\n6. Surgery planned as part of definitive local therapy\n7. ECOG PS 0-1\n8. Absolute neutrophil count ≥ 1.5 x 109\u002FL\n9. Platelet count ≥ 100 x 109\u002FL\n10. Hemoglobin ≥ 9 g\u002Fdl or ≥ 5.6 mmol\u002FL\n11. Creatinine ≤ 1.5X the upper limit of normal OR creatinine clearance ≥ 60 ml\u002Fmin\n12. Total bilirubin ≤ 1.5X the ULN; ≤ 2x ULN for patients with Gilbert's disease\n13. AST and ALT ≤ 2.5X ULN\n14. INR\u002FPT\u002FaPTT ≤ 1.5X ULN or within the therapeutic range if on anti-coagulation\n15. If pre-menopausal, negative urine or serum pregnancy test\n\nExclusion Criteria:\n\n1. Invasive breast cancer \\> 1mm on pathologic evaluation\n2. Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)\n3. Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study\n4. Recurrent ipsilateral DCIS\n5. Current steroid therapy (doses for physiologic replacement in adrenal dysfunction or for contrast allergy pre-medication for contrast allergy or similar indication allowed, topical, ocular and intranasal steroids allowed)\n6. Current Immunomodulator therapy (includes anti-CD20 antibodies)\n7. History of autoimmune disease requiring systemic immunosuppression, or active autoimmune disease. Replacement therapy with thyroxine, insulin, and physiologic corticosteroids for adrenal or pituitary insufficiency is acceptable.\n8. History of immune deficiency\n9. Active infection requiring systemic therapy\n10. Any medical or psychiatric condition, substance abuse disorder, medical therapy, or laboratory abnormality that might interfere with the patient's participation for the full duration of the study or compliance with the requirements of the study\n11. Known active hepatitis B (hepatitis B surface antigen-reactive) or hepatitis C (hepatitis C virus RNA positive). Patients who are hepatitis B core antibody positive without hepatitis B surface antigen reactivity are eligible. Patients who have antibody for hepatitis C are eligible only if hepatitis C RNA is negative by PCR.\n12. Known history of HIV (presence of HIV antibodies for HIV 1 and HIV 2)\n13. Received a live vaccine within 30 days of the first dose of treatment\n14. History of allergies to any component of the MUC1 vaccine or HiltonolR adjuvant\n15. Participation on any investigational vaccine, drug, or device trial within the last 30 days\n16. Pregnant or breastfeeding",{"count":229,"type":19},50,[124],"Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.",[25],[234,235,236,237],"T cells","cancer vaccine","immune checkpoint","lyse tumor cells","2026-03-09",{"date":240,"type":37},"2026-03-12",{"date":242,"type":37},"2024-02-07",{"date":244,"type":19},"2029-03-31",{"name":246,"class":44},"Finn, Olivera, PhD",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":20,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":45},"100585523","novel-cavity-marking-technique-in-breast-cancer-patients-undergoing-breast-conservation-surgery-with-oncoplastic-reconstruction-for-the-delivery-of-adjuvant-radiotherapy-and-accuracy-of-recommended-re-excisions-100585523","NCT06903468","Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions","Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* A pathological diagnosis consistent with non-invasive ductal carcinoma in-situ (DCIS) and invasive breast cancer, Tis-T3N0-3M0\n* Subject is planning to undergo or has undergone breast conservation surgery and oncoplastic reconstruction with cavity marking surgery.\n* ECOG Performance status of 0-1\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.\n* Subjects must not have more than one active malignancy at the time of enrollment (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 \\[as determined by the treating physician or approved by the PI\\] may be included).\n* Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy during surgery and radiation therapy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during the surgery and radiation portions of the trial and the potential risk factors for an unintentional pregnancy. SOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as amenorrhea that has lasted for ≥ 12 consecutive months without another cause.\n\nExclusion Criteria:\n\n* Patient not recommended for, or have declined, adjuvant radiotherapy\n* Subjects with prior ipsilateral breast surgery and identifiable surgical clips.\n* Subjects who are confirmed to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detailed for treatment of either a psychiatric or physical illness.",{"count":229,"type":19},[84],"This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery. Our proposed cavity marking schema will allow radiation oncology to identify the cavity margins more accurately on CT simulation for radiation planning and delivery. This cavity marking schema also provides more accurate margin identification in patients recommended for re-excision of close or positive margins.",[25,87],[258,259,260,261,262,263,31],"invasive breast cancer","non-invasive ductal carcinoma in-situ","oncoplastic reconstruction","breast conservation surgery","boost volume","cavity marking","2025-12-08",{"date":266,"type":37},"2025-12-15",{"date":268,"type":37},"2025-10-27",{"date":270,"type":19},"2029-11",{"name":43,"class":44},{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":20,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":45},"100600255","a-study-of-disappearing-markers-for-daily-radiation-treatment-delivery-for-breast-cancer-patients-100600255","NCT07095114","A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.","A Phase I\u002FII Study of Disappearing Markers for Daily Radiation Treatment Delivery","Inclusion Criteria:\n\n* Participant must have histologically or cytologically confirmed stage 0 ductal carcinoma in situ (DCIS), I, II or III breast cancer and be planning to undergo radiation therapy (RT) after surgery\n* Participants must be 18 years of age or older\n* Participant must be able to understand a written informed consent document and be willing to sign it\n* Participant must be assigned female at birth\n* Participant must have a Karnofsky performance score of greater than or equal to 70%\n* Women of child bearing potential must agree to avoid becoming pregnant through defined periods during the course of RT and must meet one of the following:\n\n  * Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy\n  * Post-menopausal, defined as no menses for at least 12 months prior to the screening visit without alternative medical causation\n  * Agree to practice true abstinence from sexual intercourse\n  * Not in a sexual relationship in which the may become pregnant (i.e., same-sex relationship)\n  * If they are childbearing potential, agree to use at least one highly effective and at least one additional method of contraception.\n* For the first six participants only: Participant must have a Fitzpatrick Skin Tone Scale of 5 or 6\n\nExclusion Criteria:\n\n* Participants who have received prior radiation treatment to the affected breast.\n* Participants with a history of allergic reaction or hypersensitivity attributed to any tattoo ink\n* Participants with active chronic skin diseases such as psoriasis. Participants with inactive or controlled skin diseases are eligible for this study\n* Participants that are pregnant or breastfeeding. If a participant wishes to participate in this study, breastfeeding should be discontinued\n* Participants with a BMI greater than 44.5 as calculated within six months prior to the starting of the study. If there are multiple BMI measurements available in the chart, the most recent will be used to determine eligibility.",{"count":18,"type":19},[84],"The goal of this clinical trial is to learn if tattoos applied with Magic Ink is as safe as commercially available standard tattoo ink for the purpose of radiation in women with breast cancer undergoing radiation treatment. The main questions are:\n\n* Is the Magic Ink as safe as standard tattoo ink\n* Does Magic Ink continue to function and remain visible for radiation therapists during the treatment Participants will be consented and given a skin assessment. Once enrolled participants will be administered the Magic Ink tattoo instead of the standard tattoo ink in preparation for their radiation treatment. Participants will also complete a survey regarding body image. Skin assessment will occur again after the first week of radiation and at 3 months later. Throughout the radiation therapy the medical physicist will complete surveys about ease of set-up of the equipment.",[25,283,284,285],"Stage I Breast Cancer","Stage II Breast Cancer","Stage III Breast Cancer","2025-09-12",{"date":288,"type":37},"2025-09-18",{"date":290,"type":37},"2025-08-18",{"date":292,"type":19},"2026-08-08",{"name":294,"class":44},"Barbara Ann Karmanos Cancer Institute",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":53,"minAge":302,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":20,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":45},"100568186","phase-2-preoperative-partial-breast-irradiation-in-early-stage-breast-cancer-100568186","NCT06677944","Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer","Impact of Preoperative Stereotactic Partial Breast Irradiation on Treatment Response, Treatment-related Toxicity, and Cosmetic Outcomes in Early-stage Breast Cancer: A Prospective, Phase II Clinical Trial","Inclusion Criteria:\n\n* Histologically confirmed ductal carcinoma in situ (DCIS) and invasive breast cancer.\n* Age ≥ 45\n* cT1\u002FcN0, tumor size ≤ 2.5cm\n* ECOG 0\\~2 -ER+, HER2-\n\nExclusion Criteria:\n\n* cN+\n* Tumor located too close to the skin or chest wall (within 5 mm)\n* With previous treatment history for breast cancer\n* Neoadjuvant chemotherapy\n* Multicentric disease\n* Diffuse microcalcification\n* BRCA mutation\n* Paget's disease\n* In cases where tumor delineation is not achievable on CT\u002FMRI images","45 Years",{"count":304,"type":19},47,[22],"In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment. Over the past two decades, significant changes have occurred in radiotherapy for breast cancer, encompassing dose fractionation methods, radiotherapy techniques, and delineation of the radiation field. Hypofractionated radiotherapy has been reported in numerous randomized phase 3 studies to show equivalent tumor control rates, reduced acute side effects, and similar late side effects compared to conventional fractionation. Among hypofractionated radiotherapy approaches, particularly in early-breast cancer, accelerated partial breast irradiation (APBI) may be chosen over whole breast irradiation (WBI). This approach is based on data indicating that the majority of local recurrences in breast cancer occur around the site of the primary tumor. By targeting radiation to the involved breast region, it becomes possible to increase the dose per fraction while shortening the overall treatment duration due to the smaller radiation treatment volume. While careful patient selection is crucial, multiple clinical studies have demonstrated that APBI, particularly after breast-conserving surgery, yields satisfactory local control rates comparable to WBI. This is accompanied by reduced side effects, improved convenience, enhanced quality of life, and potential cost savings.\n\nTraditionally, APBI has been administered after surgery, but there is a recent trend to explore preoperative APBI. The rationale for performing preoperative APBI includes several considerations. Firstly, compared to postoperative APBI, the precise location of visually identifiable tumors allows for more accurate and targeted radiation therapy, minimizing the impact on adjacent normal tissues and achieving superior cosmetic results. Secondly, reducing the size of the preoperative lesion may enable more conservative surgery, decreasing the extent of the surgical procedure. Thirdly, it can serve as a preparatory treatment to assess tumor responsiveness. Fourthly, in some cases, it may be administered for definitive purposes, especially in elderly or frail women who may find it challenging to undergo standard treatment due to concurrent health issues.\n\nSeveral clinical studies have reported the effectiveness and validity of preoperative PBI in a few cases of early breast cancer. These studies have shown low rates of acute and chronic toxicity, with excellent cosmetic outcomes. While accumulating evidence supports preoperative PBI, there is currently a lack of comparative studies with postoperative PBI. Therefore, this study aims to compare and evaluate the overall clinical advantages, including safety and efficacy, of preoperative PBI and postoperative PBI in early breast cancer patients.",[87,25,308],"Invasive Breast Cancer","2024-11-06",{"date":311,"type":37},"2024-11-07",{"date":313,"type":37},"2023-10-13",{"date":315,"type":19},"2026-10-12",{"name":317,"class":44},"Yonsei University",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":100,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":20,"phases":325,"briefSummary":326,"conditions":327,"keywords":328,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":45},"100456013","cryoablation-as-a-minimally-invasive-alternative-to-surgery-for-managing-ductal-carcinoma-in-situ-100456013","NCT05218044","Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ","Inclusion Criteria:\n\n* DCIS spanning 2 cm or less based on its radiographic appearance by mammography and\u002For breast contrast-enhanced MRI\n* Diagnosis of DCIS by minimally invasive needle biopsy\n* No prior history of DCIS or invasive breast cancer in the same breast\n* No history of surgical biopsy and\u002For lumpectomy for diagnosis\u002Ftreatment in the same breast\n* Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation\n* Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months\n* No history of breast radiation in the same breast",{"count":18,"type":19},[84],"Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.",[25],[100],"2023-03-02",{"date":331,"type":37},"2023-03-03",{"date":333,"type":37},"2021-11-01",{"date":335,"type":19},"2026-11-01",{"name":337,"class":44},"Glendale Adventist Medical Center d\u002Fb\u002Fa Adventist Health Glendale",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":345,"sex":53,"minAge":144,"maxAge":346,"enrollmentInfo":347,"targetDuration":348,"studyType":180,"phases":4,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":361},"100438111","accelerated-partial-breast-irradiation-apbi-using-stereotactic-body-radiation-therapy-sbrt-100438111","NCT04985032","Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)","Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial","Inclusion Criteria:\n\n1. Women 50 years or older\n2. Low to intermediate grade DCIS or invasive ductal carcinoma\n3. Tumor size \\\u003C 2 cm invasive ductal carcinoma and \\\u003C 2.5 cm DCIS\n4. Well defined lumpectomy cavity on CT\n5. Clear surgical ink margins \\> 2mm for invasive cancer and \\> 3 mm for DCIS\n6. Node negative\n7. Unifocal lesion\n8. ER and\u002For PR positive\n9. HER-2 negative\n10. BRCA negative\n11. Lumpectomy cavity must be \\\u003C 30% of whole breast volume\n\nExclusion Criteria:\n\n1. Lobular histology\n2. Angiolymphatic invasion\n3. Multiple foci of disease\n4. Lymphovascular invasion\n5. Active lupus or sarcoid\n6. Distant metastases\n7. Non-epithelial malignancies\n8. Synchronous contralateral breast cancer\n9. Grade 2 or higher oncoplastic surgery\n10. Ipsilateral pacemaker\n11. Ipsilateral breast implant\n12. Neoadjuvant chemotherapy\n13. Prior ipsilateral breast cancer or thoracic radiation\n14. Poor breast integrity\n15. Paget's Disease of the nipple\n16. Pregnant patients\n17. Severe cardiac, pulmonary, or liver diseases",true,"100 Years",{"count":204,"type":19},"5 Years","This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years",[25,351],"Invasive Ductal Carcinoma of Female Breast","2022-08-03",{"date":354,"type":37},"2022-08-05",{"date":356,"type":19},"2022-08-15",{"date":358,"type":19},"2027-06",{"name":360,"class":44},"RPCR, Inc.",2,{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":53,"minAge":369,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":20,"phases":372,"briefSummary":373,"conditions":374,"keywords":377,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"100413697","phase-2-impact-of-neoadjuvant-hormonal-therapy-on-the-surgical-management-of-extensive-ductal-carcinomas-in-situ-100413697","NCT04666961","Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ","HORNEO01","Inclusion Criteria:\n\n1. Patient ≥ 40 years old\n2. Histological diagnosis of ductal carcinoma in situ without infiltrating contingent\n3. Clinical T0N0\n4. Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status\n5. Indication for mastectomy\n6. DCIS visible on MRI performed with clip sequence\n7. Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.\n8. Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.\n9. Affiliated patient or beneficiary of the social security system.\n\nExclusion Criteria:\n\n1. Invasive breast carcinoma\n2. Lobular carcinoma in situ\n3. pN+ patient\n4. Indication for conservative surgery\n5. Contraindications to anastrozole or tamoxifen\n6. Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6.\n7. Histologically proven multifocal lesion\n8. Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)\n9. History of homolateral breast cancer\n10. Ongoing contralateral breast cancer\n11. Known mutation BRCA1 BRCA2\n12. Other cancer in progress at inclusion\n13. Pregnant woman, or breastfeeding,\n14. Persons deprived of liberty or under guardianship or trusteeship,\n15. Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.","40 Years",{"count":371,"type":19},262,[22],"Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications.\n\nThis mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients.\n\nNeoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy.\n\nAdjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence.\n\nThe HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.",[25,375,376],"Extensive Disease","Mastectomy",[378,379,380,381,382,383],"Neoadjuvant hormonotherapy","Tamoxifen","Anastrozole","conservative surgery","Breast cancer","extensive microcalcifications","2022-04-21",{"date":386,"type":37},"2022-04-22",{"date":388,"type":37},"2021-02-03",{"date":390,"type":19},"2033-08-01",{"name":392,"class":44},"Institut Cancerologie de l'Ouest",8]