[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anatomic-stage-iia-breast-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anatomic-stage-iia-breast-cancer-ajcc-v8":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,138,164,190,214,242],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":137},"100612878","social-health-activity-behaviors-and-quality-of-life-among-young-adult-cancer-survivors-100612878",false,"NCT07259304","Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors","Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors: A Longitudinal Study","Inclusion Criteria:\n\n* Diagnosed and\u002For treated with cancer between ages 18-39 at USC hospitals.\n* Cancer types prototypical for adolescents and young adults (AYAs) and cancer stages I-III; select patients with stage IV disease may be eligible, with approval by the principal investigator (PI) and in consultation with the treating clinician.\n* Must be within three months of a de novo cancer diagnosis at recruitment and on\u002Findicated for curative therapy (any modality). Patients may continue on adjuvant therapy throughout duration of the study.\n* Patients must have anticipated survival of \\>1-year at time of diagnosis.\n\nExclusion Criteria:\n\n* Diagnosis of blood malignancies such as leukemias (these cancers have divergent treatment patterns of longer duration than other cancers and are more commonly pediatric cancers). Some early stage lymphomas with favorable prognoses may be eligible, with approval by the PI and in consultation with the treating clinician.\n* Primary language other than English or Spanish.\n* Inability to complete a survey and\u002For wear an accelerometer either per the patient or in consultation with the clinician's judgment.","ALL","18 Years","39 Years",{"count":20,"type":21},250,"ESTIMATED","OBSERVATIONAL","This study assesses how personal relationships (such as friendships, family relationships, or romantic partners) influence the physical activity (exercise) and well-being of young adult cancer survivors. Researchers also hope to learn how social relationships change after a cancer diagnosis, and how these changes might impact important health behaviors. The information provided may help researchers learn more about better ways to support young cancer patients in the future through interventions that help maintain good social relationships and health levels of physical activity.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IA Breast Cancer AJCC v8","Anatomic Stage IB Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","Anatomic Stage IIB Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Central Nervous System Neoplasm","Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage IA Cutaneous Melanoma AJCC v8","Clinical Stage IB Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Clinical Stage IIA Cutaneous Melanoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Hodgkin Lymphoma","Malignant Bone Neoplasm","Malignant Brain Neoplasm","Malignant Solid Neoplasm","Malignant Testicular Neoplasm","Non-Hodgkin Lymphoma","Pathologic Stage I Cutaneous Melanoma AJCC v8","Pathologic Stage IA Cutaneous Melanoma AJCC v8","Pathologic Stage IB Cutaneous Melanoma AJCC v8","Pathologic Stage II Cutaneous Melanoma AJCC v8","Pathologic Stage IIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIC Cutaneous Melanoma AJCC v8","Pathologic Stage III Cutaneous Melanoma AJCC v8","Pathologic Stage IIIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Prognostic Stage I Breast Cancer AJCC v8","Prognostic Stage IA Breast Cancer AJCC v8","Prognostic Stage IB Breast Cancer AJCC v8","Prognostic Stage II Breast Cancer AJCC v8","Prognostic Stage IIA Breast Cancer AJCC v8","Prognostic Stage IIB Breast Cancer AJCC v8","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Stage I Cervical Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Differentiated Thyroid Gland Carcinoma AJCC v8","Stage I Ovarian Cancer AJCC v8","Stage I Thyroid Gland Medullary Carcinoma AJCC v8","Stage I Uterine Corpus Cancer AJCC v8","Stage IA Cervical Cancer AJCC v8","Stage IA Ovarian Cancer AJCC v8","Stage IA Uterine Corpus Cancer AJCC v8","Stage IA1 Cervical Cancer AJCC v8","Stage IA2 Cervical Cancer AJCC v8","Stage IB Cervical Cancer AJCC v8","Stage IB Ovarian Cancer AJCC v8","Stage IB Uterine Corpus Cancer AJCC v8","Stage IB1 Cervical Cancer AJCC v8","Stage IB2 Cervical Cancer AJCC v8","Stage IC Ovarian Cancer AJCC v8","Stage II Cervical Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Differentiated Thyroid Gland Carcinoma AJCC v8","Stage II Ovarian Cancer AJCC v8","Stage II Thyroid Gland Medullary Carcinoma AJCC v8","Stage II Uterine Corpus Cancer AJCC v8","Stage IIA Cervical Cancer AJCC v8","Stage IIA Colorectal Cancer AJCC v8","Stage IIA Ovarian Cancer AJCC v8","Stage IIA1 Cervical Cancer AJCC v8","Stage IIA2 Cervical Cancer AJCC v8","Stage IIB Cervical Cancer AJCC v8","Stage IIB Colorectal Cancer AJCC v8","Stage IIB Ovarian Cancer AJCC v8","Stage IIC Colorectal Cancer AJCC v8","Stage III Cervical Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Differentiated Thyroid Gland Carcinoma AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Thyroid Gland Medullary Carcinoma AJCC v8","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Colorectal Cancer AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Colorectal Cancer AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Colorectal Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","RECRUITING","2026-05-26",{"date":128,"type":129},"2026-05-28","ACTUAL",{"date":131,"type":129},"2021-11-24",{"date":133,"type":21},"2027-12-31",{"name":135,"class":136},"University of Southern California","OTHER",2,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":145,"minAge":146,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":137},"100468390","phase-3-testing-laser-therapy-for-treatment-of-vaginal-dryness-in-survivors-of-breast-cancer-the-revitalize-trial-100468390","NCT05379153","Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial","The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors","Inclusion Criteria:\n\n* Women with a history of breast cancer treated with curative intent who have completed primary therapy (consisting of surgery with or without chemotherapy, targeted therapy, immunotherapy and\u002For radiation) \\>= 12 months prior to registration. Concurrent trastuzumab \u002Fpertuzumab is permissible\n* May be receiving ongoing adjuvant endocrine therapy (with an AI or tamoxifen +\u002F- ovarian function suppression). Patients are not required to receive these treatments to be eligible. Participants receiving adjuvant endocrine therapy prior to registration must intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient's medical oncologist. Patients on aromatase inhibitor (AI) therapy, tamoxifen with or without ovarian function suppression therapy must have been on their current endocrine therapy regimen for at least 6 months prior to registration\n* Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as \\>= 4 on a 0-10-point scale that has been bothersome for \\>= 3 months and for which the patient wants to undergo the study procedure\n* No evidence of metastatic breast cancer. Scans to assess for metastatic disease are not required for eligibility\n* No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with cervical intraepithelial neoplasia are eligible\n* No history of scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder or collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis or vulvar vestibulitis\n* No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (Bilateral salpingooophorectomy) are eligible\n* No systemic estrogen or progesterone, vaginal estrogen, vaginal prasterone, ospemifene, and\u002For androgen therapy within 6 weeks prior to registration\n* No other suspected contraindications for undergoing laser therapy\n* No prior vaginal laser therapy at any time. Patients who would have completed any type of vaginal laser resurfacing procedure at any time prior to the start of study treatment are not eligible\n* No known concurrent invasive carcinoma\u002Fmalignancy. Patients with carcinoma in situ are eligible. Patients with a prior 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 if not currently receiving treatment\n* Postmenopausal based on at least one of the following criteria at the time of registration:\n\n  * Women 50 or older with no spontaneous regular menses \\> 12 months\n  * On ovarian suppression (i.e., gonadotrophin releasing hormone \\[GNRH\\] agonist\u002Fantagonist) for at least 6 months or greater, with plans to continue such treatment for at least 18 weeks\n  * Bilateral oophorectomy\n  * Women on AI therapy (i.e., clinically judged to be postmenopausal)\n* In order to complete the mandatory patient-completed measures, participants must be able to speak, read and understand English or Spanish\n* Age \\>= 22 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* No medical history of: keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of \\\u003C 2 cm between the vaginal opening and the anal opening)","FEMALE","22 Years",{"count":20,"type":21},"INTERVENTIONAL",[150],"PHASE3","This phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness.",[153,25,26,27,28,29,30,31,32,33,34,154],"Anatomic Stage 0 Breast Cancer AJCC v8","Vaginal Atrophy","2026-05-07",{"date":157,"type":129},"2026-05-11",{"date":159,"type":129},"2026-04-21",{"date":161,"type":21},"2027-05",{"name":163,"class":136},"Alliance for Clinical Trials in Oncology",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":145,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":148,"phases":173,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100279522","decision-making-tool-in-supporting-decision-making-in-contralateral-prophylactic-mastectomy-in-patients-with-newly-diagnosed-breast-cancer-100279522","NCT02918474","Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer","Decision Making Tool for Contralateral Prophylactic Mastectomy","Inclusion Criteria:\n\n* Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer\n* Able to speak read or write English\n\nExclusion Criteria:\n\n* Patients with previous breast cancer\n* Prior history of bilateral prophylactic mastectomy\n* Known to have a germline mutation that predisposes them to an increased risk of breast cancer (e.g. BRCA1\u002F2) and\u002For they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer",{"count":172,"type":21},15,[174],"NA","This trial studies the acceptability and how well decision making tool works in supporting decision making in contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer. Decision making tool may help patients with early stage breast cancer make decisions regarding their surgical options.",[25,26,27,28,29,30,31,32,33,34,177,178,62,63,64,65,66,67,68,69,70,71,179],"Ductal Breast Carcinoma In Situ","Invasive Breast Carcinoma","Sporadic Breast Carcinoma","2026-04-13",{"date":182,"type":129},"2026-04-16",{"date":184,"type":129},"2017-04-28",{"date":186,"type":21},"2026-09-30",{"name":188,"class":136},"M.D. Anderson Cancer Center",1,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":145,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":148,"phases":199,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":212,"locationsCount":189},"100471317","early-phase-1-topical-or-oral-minoxidil-for-the-treatment-of-endocrine-therapy-induced-alopecia-in-patients-with-stage-i-iv-breast-cancer-100471317","NCT05417308","Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer","A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients","Inclusion Criteria:\n\n* Women \\>= 18 years of age\n* Established diagnosis of breast cancer stages I-IV\n* On endocrine therapy including tamoxifen or aromatase inhibitors with or without concurrent use of ovarian function suppression\n* Self-reporting hair loss since starting endocrine therapy\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Current chemotherapy use or prior chemotherapy use within the last 2 years\n* History of scarring\u002Fcicatricial alopecia or alopecia areata\n* Prior use of oral or topical minoxidil\n* Prior or ongoing use of spironolactone\n* Known sensitivity to minoxidil\n* Untreated hypothyroidism or iron deficiency as determined by thyroid stimulating hormone (TSH) with reflex free T4 and ferritin level \\> 40 to be checked at the time of enrolling if not completed in the 12 months prior",{"count":198,"type":21},50,[200],"EARLY_PHASE1","This early phase I trial studies the possible benefits and\u002For side effects of topical or oral minoxidil in treating endocrine therapy-induced hair loss (alopecia) in patients with stage I-IV breast cancer. Endocrine therapy-induced alopecia (EIA) is a distressing side effect that leads to reduced quality of life and early cessation of therapy in women undergoing treatment for breast cancer. Patients on endocrine therapy commonly report hair loss or thinning. Minoxidil is a drug that may promote hair growth and reduce hair loss. Oral minoxidil may increase hair density in women with EIA, and work the same as topical minoxidil in treating EIA in patients with breast cancer.",[25,26,27,28,29,30,31,32,33,34,203,204,62,63,64,65,66,67,68,69,70,71,205],"Anatomic Stage IV Breast Cancer AJCC v8","Endocrine Therapy-Induced Alopecia","Prognostic Stage IV Breast Cancer AJCC v8","2026-03-06",{"date":208,"type":129},"2026-03-10",{"date":210,"type":129},"2023-03-01",{"date":133,"type":21},{"name":213,"class":136},"Ohio State University Comprehensive Cancer Center",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":148,"phases":223,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100541006","phase-1-personalized-vaccine-immunotherapy-in-combination-with-checkpoint-inhibitor-for-treatment-of-triple-negative-breast-cancer-100541006","NCT06324240","Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer","Clinical Evaluation of a Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Triple Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n* Must be age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days prior to tissue consent\n* Absolute neutrophil count \\> 1500\u002FmcL (obtained within 14 days prior to vaccine administration)\n* Absolute lymphocyte count \\>= 600 cells\u002Fµl (obtained within 14 days prior to vaccine administration)\n* Platelets \\> 100,000 mm (obtained within 14 days prior to vaccine administration)\n* Hemoglobin \\> 9.0 g\u002FdL (obtained within 14 days prior to vaccine administration) (NOTE: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\> 9.0g\u002Fdl is acceptable)\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or calculated creatinine clearance \\>= 60 mL\u002Fmin using Cockcroft-Gault equation for patients with creatinine levels \\> 1.5 x institutional ULN (obtained within 14 days prior to vaccine administration)\n* Total bilirubin =\\\u003C 1.5 x ULN OR direct bilirubin =\\\u003C 1 x ULN (obtained within 14 days prior to vaccine administration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN unless liver metastases are present, in which case they must be =\\\u003C 5 x ULN (obtained within 14 days prior to vaccine administration)\n* Bilirubin =\\\u003C 1.5 X ULN (except in participants with documented Gilbert's disease, who must have a total bilirubin =\\\u003C 3.0 mg\u002FdL) (obtained within 14 days prior to vaccine administration)\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (obtained within 14 days prior to vaccine administration)\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (obtained within 14 days prior to vaccine administration)\n* TNBC as defined by estrogen receptor (ER)\u002Fprogesterone receptor (PR) =\\\u003C 10% if Allred =\\\u003C 3; Her2\u002Fneu negative as defined by scores of 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \\\u003C 2.0 or \\\u003C 6 Her2 copies per cell\n* Patients with metastatic or inoperable locally advanced disease: Metastatic or inoperable locally advanced disease is defined as either histologically confirmed metastatic breast cancer by biopsy; or locally advanced breast cancer that, in the opinion of the treating physician, is not amenable to curative intent surgical resection; or, radiological or clinical evidence suggestive and supportive of metastatic disease\n\n  * Documented metastatic biopsy is not required provided the patient has a prior diagnosis of TNBC that otherwise meets the eligibility criteria\n  * Eligible patients must have =\\\u003C 3 lines of chemotherapy in the metastatic\u002Fadvanced disease setting. For patients who have relapsed within 6 months of systemic therapy given within curative intent, that therapy will count as a line of metastatic therapy. Last cycle of cytotoxic therapy must be \\>= 21 days prior to cycle (C)1 day (D)1 of vaccine. Last cycle of checkpoint inhibitor therapy be \\>= 28 days prior to C1D1 of vaccine. Last dose of radiotherapy must be \\>= 14 days prior to C1D1 of vaccine\n  * Prior checkpoint inhibitor is permitted. Patients who are known to have PD-L1 positive with combined positive score (CPS) \\>= 10 will be required to have had pembrolizumab therapy prior to enrollment\n  * Patients who are metastatic or inoperable, locally advanced will only be eligible for the Phase 1b combination cohort. They will not be eligible for the Phase 1a dose escalation cohort. Patients who have received prior anti-CTLA-4 antibody will preferentially be enrolled to cohort B (combination of TMV vaccine with pembrolizumab). Patients who have received prior PD-L1 or PD-1 antibody therapy will preferentially be enrolled to cohort C (combination of TMV vaccine with ipilimumab). Patients with metastatic disease who have received no prior immune checkpoint inhibitor therapy will be assigned to a treatment arm based on available slots and discretion of treating physician\n* Patients with early stage TNBC: Early stage TNBC is defined as clinical or pathologic Stage I-III TNBC\n\n  * After resection of disease in the breast and axilla, early stage patients are eligible for either the Phase 1a dose escalation of TMV vaccine monotherapy Cohort A or the Phase 1b combination arm of the vaccine with immune checkpoint inhibitor (ICI)\n  * Patients will be required to have completed adjuvant radiotherapy (if indicated) \\>= 14 days prior to initiation of vaccine on trial\n  * Patients who have residual disease after completion neoadjuvant therapy that proceed with adjuvant capecitabine can enroll \\>= 28 days after completion of final dose of capecitabine. Patients electing to enroll onto the Phase 1a Cohort A monotherapy arm can enroll prior to initiation of capecitabine, however must not initiate capecitabine prior to the Week 12 blood draw (measurement of immune biomarkers) on study\n  * Patients who have a germline BRCA 1\u002F2 mutation that meet the Food and Drug Administration (FDA) indication for use of adjuvant Olaparib can enroll \\>= 28 days after completion of final dose of olaparib. Patients electing to enroll onto the Phase 1a Cohort A monotherapy arm can enroll prior to initiation of olaparib, however must not initiate olaparib prior to the Week 12 blood draw (measurement of immune biomarkers) on study\n  * Patients who undergo upfront surgery: Patients may initiate injection of vaccine \\>= 28 days after completion of final cycle of adjuvant chemotherapy\n  * Patients who have early stage breast cancer that have residual disease after completing neoadjuvant chemotherapy with the KEYNOTE 522 regimen (pembrolizumab at a dose of 200 mg every 3 weeks plus weekly paclitaxel and carboplatin for 4 cycles followed by pembrolizumab-doxorubicin-cyclophosphamide or of pembrolizumab-epirubicin-cyclophosphamide every 3 weeks for 4 cycles):\n\n    * Patient enrolling onto Phase 1a Cohort A will initiate injection of vaccine \\>= 28 days after completion of final cycle of standard of care adjuvant pembrolizumab\n    * Patient enrolling onto Phase 1b Cohort B or C will initiate injection of vaccine \\>= 28 days surgical resection. Patients who have received pembrolizumab as part of the preoperative KEYNOTE 522 regimen will preferentially be enrolled to cohort B (combination of TMV vaccine with pembrolizumab) and will receive up to 9 cycles of adjuvant pembrolizumab every 3 weeks as per standard of care. Vaccine will be administered every 2 weeks for 3 doses prior to the first three ICI cycles\n  * Patients who have early stage breast cancer that have that have residual disease after completing neoadjuvant chemotherapy with either dose-dense doxorubicin-cyclophosphamide followed by paclitaxel or docetaxel-cyclophosphamide:\n\n    * Patient enrolling onto Phase 1a Cohort A will initiate injection of vaccine \\>= 28 days surgical resection\n    * Patient enrolling onto Phase 1b Cohort B or C will initiate injection of vaccine \\>= 28 days surgical resection. Patients will be assigned to receive either pembrolizumab (Cohort B) every 3 weeks for 6 cycles or ipilimumab (Cohort C) every 3 weeks for 4 cycles in combination with TMV vaccine based on available slots in each arm and discretion of treating physician. Vaccine will be administered every 2 weeks for 3 doses; the TMV vaccine will be administered prior to the ICI cycle if ICI is due.\n* Weight of tumor tissue for production of vaccine must be at least 1 gram. In metastatic patients, preferentially, invasive tumor in breast or lymph node tissue will be retrieved by excisional biopsy to ensure sufficient yield. In metastatic patients who undergo initiation of first-line standard of care systemic therapy off study (i.e. pembrolizumab and chemotherapy in a PD-L1 positive patient), then ideally collection of tumor tissue will occur prior to treatment initiation of standard of care therapy to maximize cellularity. Metastatic patients who have undergone mastectomy during curative treatment initially or have no invasive disease in the breast, chest wall, or accessible regional lymph nodes, will be evaluated for image-guided core biopsies of liver metastasis or video-assisted thorascopic wedge resection of lung metastasis\n\n  * In patients with early stage TNBC undergoing upfront surgery, the tumor tissue will be retrieved during lumpectomy\u002Fmastectomy. In early stage patients who are identified as high risk of having residual disease after neoadjuvant chemotherapy or undergo upfront resection, tissue will be retrieved during planned lumpectomy or mastectomy\n* Measurable disease is not required in metastatic patients but patients must have sufficient tumor to yield 1g on biopsy to enable production of personalized TMV vaccine product\n* Patients will undergo germline testing to assess for a BRCA1\u002FBRCA2 deleterious mutation. Knowledge of germline status is not required to enroll on the study\n* Able and willing to complete the entire study according to the study schedule\n* Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart\n\nExclusion Criteria:\n\n* Weight of the tumor tissue is less 1 gram\n* Clinically significant comorbid conditions such as cardiovascular disease or significant peripheral vascular (e.g., uncontrolled hypertension, myocardial infarction, unstable angina) within 6 months of study entry, serious cardiac arrhythmia requiring medication, and uncontrolled infection\n* No second malignancy except prior breast cancer or except non-melanomatous skin cancer within the past 5 years\n* Ongoing or planned systemic anti-cancer therapy or radiation therapy. Last cycle of cytotoxic therapy must be \\>= 21 days prior to C1D1 of vaccine. Last cycle of checkpoint inhibitor therapy be \\>= 28 days prior to C1D1 of vaccine. Last dose of radiotherapy must be \\>= 14 days prior to C1D1 of vaccine\n* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment\n* Has a known history of active tuberculosis (Bacillus Tuberculosis)\n* History of allogeneic organ transplant\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for management of brain metastases for at least 7 days prior to study treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Known history of non-infectious pneumonitis that required steroids or any evidence of active pneumonitis\n* Failure to recover from grade 3 or 4 toxicity from previous treatment\n* For the combination cohort: prior grade 4 immune-related adverse events due to previous ICI. Patients who experienced grade 2 or 3 toxicity with prior ICI therapy may enroll if toxicity reverted to =\\\u003C grade 1",{"count":222,"type":21},18,[224],"PHASE1","This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.",[25,26,27,28,29,30,31,32,33,34,203,227,228,229,62,63,64,65,66,67,68,69,70,71,205,230,231],"Early Stage Triple-Negative Breast Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Metastatic Triple-Negative Breast Carcinoma","Recurrent Breast Carcinoma","Unresectable Triple-Negative Breast Carcinoma","2026-01-23",{"date":234,"type":129},"2026-01-26",{"date":236,"type":129},"2025-12-02",{"date":238,"type":21},"2026-12-31",{"name":240,"class":136},"Emory University",4,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":145,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":148,"phases":251,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":189},"100527905","phase-2-neurotization-of-the-nipple-areolar-complex-to-restore-sensation-for-patients-with-breast-cancer-undergoing-nipple-sparing-mastectomy-and-reconstruction-100527905","NCT06153836","Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction","Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction","Inclusion Criteria:\n\n* Female patients age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Planned nipple sparing mastectomy (NSM)\n* Ideal NSM candidates would meet the following criteria:\n\n  * Cup size A-C\n  * BMI \\\u003C34\n  * Ptosis grade \\\u003C 2\n  * Clinical stage 0 - T2N0\n  * Final planned implant volume \\\u003C 400cc\n  * Inframammary or lateral mammary incision\n  * Tumor \\> 0.5cm from the nipple areolar complex (NAC)\n  * No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM\n  * No prior breast radiation on side of planned NSM\n  * Tumor \\\u003C0.5cm from NAC (including suspicious calcifications or MRI enhancement)\n  * No planned post mastectomy radiation (PMRT)\n  * No nicotine use within 4 weeks of surgical date\n\nExclusion Criteria:\n\n* Planned autologous reconstruction (immediate or delayed)\n* Pregnancy",{"count":250,"type":21},20,[252],"PHASE2","This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.",[153,25,29],"2025-12-03",{"date":257,"type":129},"2025-12-04",{"date":259,"type":129},"2023-12-05",{"date":261,"type":21},"2026-11-10",{"name":263,"class":136},"Mayo Clinic"]