[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-i-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-i-breast-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,75,107,143,176,198],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100427966","phase-3-de-escalation-of-breast-radiation-trial-for-hormone-sensitive-her-2-negative-oncotype-recurrence-score-less-than-or-equal-to-18-breast-cancer-debra-100427966",false,"NCT04852887","De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)","A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer","DEBRA","Inclusion Criteria:\n\n* • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry\u002FStep 1 and, for patients treated in the U.S., authorization permitting release of personal health information.\n\n  * The patient must have an ECOG performance status of 0 or 1.\n  * The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection.)\n  * The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.\n  * Patient must have undergone axillary staging (sentinel node biopsy and\u002For axillary node dissection).\n  * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:\n  * By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm).\n  * By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)\n  * Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen.\n\n    \\*\\* For patients with a T1a tumor (less than or equal to 0.5 cm in size) or patients at Canadian provinces or approved international sites where Oncotype DX Recurrence Score testing would not be covered, who do not already have an Oncotype DX Recurrence Score at pre-entry\u002FStep 1, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory. Tumor size sample must be greater than or equal to 0.2 cm for analysis.\n\n    \\*\\*\\* The Oncotype RS can be run on the biopsy core or surgical specimen. The patient cannot have initiated endocrine therapy prior to tissue collection.\n  * An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary \"Low\" category will meet this eligibility criteria and an Oncotype RS does not need to be performed.\n  * The tumor must have been determined to be ER and\u002For PgR positive assessed by current ASCO\u002FCAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive.\n  * The tumor must have been determined to be HER2-negative by current ASCO\u002FCAP guidelines.\n  * Patients may be premenopausal or postmenopausal at the time of pre-entry\u002FStep 1. For study purposes, postmenopausal is defined as:\n  * Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry\u002FStep 1; or a documented hysterectomy; or\n  * Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry\u002FStep 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional\u002Flaboratory standard; or Documented bilateral oophorectomy.\n  * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry\u002FStep 1 must be no more than 70 days.\n  * The patient must have recovered from surgery with the incision completely healed and no signs of infection.\n  * Bilateral mammogram or MRI within 6 months prior to pre-entry\u002FStep 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.\n\nExclusion Criteria:\n\n* • Definitive clinical or radiologic evidence of metastatic disease.\n\n  * pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.\n  * Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.\n  * Patient had a mastectomy.\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 microcalcifications, 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) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)\n  * Paget's disease of the nipple.\n  * Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.)\n  * Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and\u002For previous contralateral LCIS are eligible.)\n  * Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.)\n  * Treatment plan that includes regional nodal irradiation.\n  * Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry\u002FStep 1.\n  * History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry\u002FStep 1.\n  * Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention.\n\n    \\*\\* Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomization\u002FStep 2) for this diagnosis after the core biopsy (and can continue postoperatively if:\n  * the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND\n  * the patient had not initiated endocrine therapy prior to core biopsy tissue collection.\n\n    \\*\\*\\* This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry\u002FStep 1).\n  * Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.\n  * Prior breast or thoracic RT for any condition.\n  * Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.\n  * Pregnancy or lactation at the time of pre-entry\u002FStep 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry\u002FStep 1.)\n  * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.\n  * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.\n  * Use of any investigational product within 30 days prior to pre-entry\u002FStep 1.","ALL","50 Years","70 Years",{"count":21,"type":22},1670,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.",[28],"Stage I Breast Cancer","RECRUITING","2026-04-22",{"date":32,"type":33},"2026-04-23","ACTUAL",{"date":35,"type":33},"2021-06-23",{"date":37,"type":22},"2041-07",{"name":39,"class":40},"NRG Oncology","OTHER",832,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100480377","telehealth-resistance-exercise-intervention-to-preserve-dose-intensity-and-vitality-in-elder-breast-cancer-patients-100480377","NCT05535192","TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients","TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)","THRIVE-65","Inclusion Criteria:\n\n* Women age \\>=65\n* Diagnosed with stage I-III invasive breast cancer\n* BMI between 18-50 kg\u002Fm2\n* Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent\n* If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents\u002Fdoses according to patient response (e.g.; I-SPY trials)\n* Self-reported ability to walk for 6 minutes and\u002For 2 blocks (with or without assistive device)\n* Ability to provide written informed consent.\n* Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters.\n\nExclusion Criteria:\n\n* Following a therapeutic diet for co-morbid disease where the THRIVE-65 diet would be contraindicated as assessed by the RD\n* Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months over the past year\n* Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year\n* Presence of medical conditions or medications that would prohibit participation in an exercise program\n* Current use of weight-loss medication\n* Documented history of alcohol or substance abuse within the past 12 months\n* History of dementia","FEMALE","65 Years",{"count":53,"type":22},270,[55],"NA","This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.",[58,59,60,28,61],"Breast Cancer","Stage III Breast Cancer","Breast Cancer Female","Stage II Breast Cancer",[58,59,61,28,63,64,65],"Exercise Intervention","Nutrition Intervention","Supportive Care","2026-04-21",{"date":32,"type":33},{"date":69,"type":33},"2023-03-20",{"date":71,"type":22},"2027-02-01",{"name":73,"class":40},"Dana-Farber Cancer Institute",3,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100485016","improving-exercise-capacity-with-a-tailored-physical-activity-intervention-100485016","NCT05595577","Improving Exercise Capacity With a Tailored Physical Activity Intervention","Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment","PALS","Inclusion Criteria:\n\nTo be considered eligible, participants must meet all of the following criteria:\n\n* Individuals aged 18- 85 years\n* Diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer\n* Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens \\[anthracyclines, trastuzumab, rituximab\\]), immuno-therapies (immune checkpoint inhibitors \\[ICI's\\]) or radiation (within 8 weeks of completion of radiation).29-31\n* Ability to speak and understand English\n* Capacity to walk at least 2 city blocks (\\~.2 miles) on a flat surface\n* Expected survival beyond 6 months.\n* Must have an assistant that will help perform the home-based testing activities\n\nExclusion Criteria:\n\nIf the patient meets any of these criteria they are excluded from the study:\n\n* Uncontrolled hypertension (systolic blood pressure \\>190 mm Hg or diastolic blood pressure \\>100 mm Hg)\n* Recent history of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion (unless approved by the participant's physician and the Principal Investigator) NOTE: In the setting of active inflammation, participation will not be approved. If chronic disease is present and stable as judged by the participant's physician and the PI, participation will be approved.\n* Contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices (unless approved by the participant's physician and the Principal Investigator)\n* Pregnant\n* Unstable angina\n* Contraindication for exercise training or testing\n* Inability to exercise on a treadmill or stationary cycle\n* Significant ventricular arrhythmias (\\>20 PVCs\u002Fmin due to gating difficulty)\n* Atrial fibrillation with uncontrolled ventricular response\n* Acute myocardial infarction within 28 days\n* Inability to provide informed consent","18 Years","85 Years",{"count":86,"type":22},110,[55],"The purpose of this research is to test whether participating in either a physical activity intervention or a series of educational classes will help to preserve exercise capability, heart function, brain-based activities (like memory), and quality of life.\n\nParticipants will be randomized to 1 of 2 pathways:\n\n* First pathway consists of organized health workshops. These workshops are intended to provide information on topics such as proper nutrition, management of stress, sleep practices, and emphasis on a healthy lifestyle that may help the participants through cancer treatment. This pathway will also test whether stretching may help participants through cancer treatment.\n* Second pathway participants will take part in some unsupervised and some potentially supervised moderate activity sessions each week throughout participants' cancer treatment to take place either remotely or in person, depending on availability of facilities at the time visits are scheduled.",[90,91,92,93,28,61,59],"Non Hodgkin Lymphoma","Heart; Functional Disturbance","Hodgkin Lymphoma","Quality of Life",[95,96],"Exercise capability","Brain activity","2026-03-19",{"date":99,"type":33},"2026-03-20",{"date":101,"type":33},"2023-03-01",{"date":103,"type":22},"2026-08-31",{"name":105,"class":40},"Wake Forest University Health Sciences",2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":127,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":5},"100596217","phase-4-a-study-of-revaree-plus-in-people-with-breast-cancer-100596217","NCT07042581","A Study of Revaree Plus in People With Breast Cancer","Evaluation of Revaree Plus in Women With Breast Cancer","Inclusion Criteria:\n\n* ≥18 years of age at the time of signing informed consent.\n* Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC\n* Able to complete study questionnaires in English or Spanish\n* Breast cancer patients must have completed primary therapy (surgery, and\u002For chemotherapy, and\u002For radiation therapy) or currently on maintenance therapy\n* Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM)\n* Currently have no clinical evidence of disease\n* Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \\[pain with intercourse or examination\\])\n* A total score of 4 or greater in VAS\n* Without history of other cancers (excluding non-melanoma skin cancer)\n* Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Vaginal bleeding of unknown etiology within 12 months of study entry\n* Currently taking hormone replacement therapy \\[local or systemic\\] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)\n* Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)\n* No known allergies to any ingredients in 10mg HLA suppository",{"count":115,"type":22},60,[117],"PHASE4","The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.",[58,120,28,61,59,121,122,123,124,125,126],"Stage 0 Breast Cancer","Stage 0 Breast Carcinoma","Stage II Breast Carcinoma","Stage III Breast Carcinoma","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast",[58,120,28,61,59,128,129,130,131,132,133,134],"Stage 0 hormone receptor positive breast cancer","Stage I hormone receptor positive breast cancer","Stage II hormone receptor positive breast cancer","Stage III hormone receptor positive breast cancer","Revaree","24-374","Memorial Sloan Kettering Cancer Center","2026-02-04",{"date":137,"type":33},"2026-02-06",{"date":139,"type":33},"2025-06-20",{"date":141,"type":22},"2029-06-20",{"name":134,"class":40},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":163,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100578450","mindfulness-based-intervention-for-depressive-symptoms-sent-via-text-mindset-100578450","NCT06811454","Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET)","A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness","Inclusion Criteria:\n\n1. Self-reported mild to moderately-severe symptoms of depression (score 5-19 on PHQ-9).\n2. A diagnosis of stage 0-III breast, prostate, or colorectal cancer.\n3. Completion of primary cancer treatment within 2 years (excludes hormone therapy).\n4. An ability to provide informed consent.\n5. An ability to read and speak English.\n6. Access to a web-enabled device (phone, tablet, computer).\n\nExclusion Criteria:\n\n1. Self-reported minimal and severe depressive symptoms (\\\u003C4 and \\> 20 on PHQ-9).\n2. Self-reported suicidal ideation (\\>1 on item 9 PHQ-9).\n3. Another psychological, medical, or other condition\u002Fissue determined that necessitates priority treatment and\u002For that would interfere with participation (e.g., schizophrenia, borderline personality disorder)\n4. Current or recent substance abuse\u002Fdependence.\n5. Stage IV cancer diagnosis.\n6. A cancer recurrence actively requiring treatment.\n7. Self-reported active mindfulness practice.\n8. Prior participation in a formal mindfulness program (e.g., MBCT, Mindfulness-Based Stress Reduction Program, Mindfulness-Based Cancer Recovery",{"count":151,"type":22},76,[55],"The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.",[155,156,59,61,28,157,158,159,160,161,162],"Depression","Cancer","Stage III Prostate Cancer","Stage II Prostate Cancer","Stage I Prostate Cancer","Stage III Colorectal Cancer","Stage II Colorectal Cancer","Stage I Colorectal Cancer",[164],"Post treatment Depression","NOT_YET_RECRUITING","2026-01-22",{"date":168,"type":33},"2026-01-23",{"date":170,"type":22},"2026-08-03",{"date":172,"type":22},"2029-03-31",{"name":174,"class":40},"Case Comprehensive Cancer Center",1,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":175},"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":184,"type":22},30,[55],"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.",[188,28,61,59],"Ductal Carcinoma in Situ","2025-09-12",{"date":191,"type":33},"2025-09-18",{"date":193,"type":33},"2025-08-18",{"date":195,"type":22},"2026-08-08",{"name":197,"class":40},"Barbara Ann Karmanos Cancer Institute",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":50,"minAge":83,"maxAge":19,"enrollmentInfo":206,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":175},"100503315","comparison-between-prepectoral-and-subpectoral-breast-reconstruction-100503315","NCT05833659","Comparison Between Prepectoral and Subpectoral Breast Reconstruction","The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy","RESPECT","Inclusion Criteria:\n\n1. Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.\n2. Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.\n3. Patients having willingness for breast reconstruction.\n4. Age between 18 to 70 years.\n5. Maximum diameter of the cancer lesion ≤ 3 cm.\n6. Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.\n7. The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.\n\nExclusion Criteria:\n\n1. patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.\n2. Having history of malignant tumor (s) within 5 years.\n3. Patients under immunosuppressive therapy for organ transplantation.\n4. Having continuous systemic steroid hormone therapy.\n5. Pregnant or lactating women.",{"count":207,"type":22},88,"OBSERVATIONAL","There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction.\n\nThis study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.",[61,28],[212,213,214,215,216],"breast cancer","endoscopic nipple-sparing mastectomy","breast reconstruction","breast satisfaction","BREAST-Q score","2023-04-16",{"date":219,"type":33},"2023-04-27",{"date":221,"type":33},"2022-03-01",{"date":223,"type":22},"2027-03",{"name":225,"class":40},"Beijing Friendship Hospital"]