[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-female\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-female":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,82,0,25,[9,53,83,110,141,161,184,210,240,266,294,315,344,389,417,441,464,490,517,542,568,589,616,648,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100555094","phase-3-pre-operative-window-of-et-to-inform-rt-decisions-power-ii-100555094",false,"NCT06507618","Pre-Operative Window of ET to Inform RT Decisions (POWER II)","A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)","POWER II","Inclusion Criteria (summary):\n\n* Diagnosis of ER+, PR +\u002F-, and HER2- non amplified invasive breast cancer and clinically negative nodes\n* ECOG performance status 0-2\n* Females, aged ≥ 65 years\n* Patient is eligible for BCS and opted for BCS\n* Patient is a candidate for radiation therapy\n* Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)\n* Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS\n* Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Bilateral synchronous breast cancer\n* Multicentric disease\n* Prior use of Tamoxifen or aromatase inhibitors\n* History of ipsilateral breast radiation therapy\n* Has a known additional malignancy that is progressing and\u002For requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI.\n* Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.","FEMALE","65 Years",{"count":21,"type":22},354,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups:\n\nIntervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery.\n\nBoth arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).",[28],"Breast Cancer Female",[30,31,32,33,34,35,36,37,38,39],"breast cancer","endocrine therapy","radiation","letrozole","anastrozole","exemestane","tamoxifen","survey","questionnaire","geriatric","RECRUITING","2026-06-25",{"date":43,"type":44},"2026-06-30","ACTUAL",{"date":46,"type":44},"2024-07-19",{"date":48,"type":22},"2034-03-01",{"name":50,"class":51},"University of Virginia","OTHER",6,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100642611","safety-feasibility-and-outcomes-of-early-rehabilitation-after-breast-cancer-surgery-100642611","NCT07651696","Safety, Feasibility, and Outcomes of Early Rehabilitation After Breast Cancer Surgery","Evaluation of the Safety, Feasibility, and Functional Outcomes of a Structured Early Rehabilitation Protocol Following Breast Cancer Surgery: A Prospective Study in Routine Clinical Practice.","EMOVE-BCS","Inclusion Criteria:\n\n* Women aged ≥18 years undergoing breast cancer surgery at Hospital Universitari i Politècnic La Fe and referred to the early postoperative rehabilitation programme through the usual care pathway.\n* Any type of breast surgery, including breast-conserving surgery and\u002For mastectomy, with or without reconstruction\u002Fprosthesis, and bilateral surgery.\n* Any type of axillary surgery, including sentinel lymph node biopsy (SLNB) and\u002For axillary lymph node dissection (ALND).\n* Patients undergoing surgery for recurrence and\u002For reoperation, for example margin widening, reoperation due to complications, or reoperation for oncological reasons, provided that it is clinically possible to start the programme.\n* Ability to understand instructions, complete questionnaires, and sign the informed consent form.-\n\nExclusion Criteria:\n\n* Inability to safely start the protocol during the first postoperative weeks due to medical or surgical contraindication, or due to severe clinical complications, for example the need for strict immobilization, specific restrictions, or prolonged hospital admission, according to the criteria of the surgical team or the rehabilitation service, preventing the protocol from being initiated according to the usual care schedule.\n* Severe pre-existing upper limb condition, unilateral or bilateral, causing significant limitation of mobility or function before surgery and making the interpretation of clinical progression unreliable, for example shoulder arthroplasty, recent fracture, frozen shoulder in the inflammatory phase with severe limitation, or untreated massive rotator cuff tear with marked functional impairment.\n* Severe neurological or musculoskeletal disease that significantly affects upper limb function and may influence the main outcome variables, for example stroke with major sequelae, spinal cord injury, or severe neuropathy.\n* Cognitive impairment, severe decompensated psychiatric disorder, or language barrier without available support, preventing the participant from understanding instructions and completing assessments.\n* Participation in another study that may substantially interfere with the results, according to the investigator's judgment.","18 Years",{"count":63,"type":22},110,[65],"NA","Breast cancer is one of the most common tumours in women. Advances in diagnosis and treatment have increased survival, but many women experience functional sequelae after breast and\u002For axillary surgery, including pain, reduced shoulder range of motion, loss of strength, difficulties in daily activities, axillary web syndrome, and possible lymphoedema. These impairments may affect autonomy, self-care, return to daily life, and correct arm positioning during adjuvant treatments such as radiotherapy.\n\nAlthough therapeutic exercise and rehabilitation are recommended within oncology care, the implementation of early rehabilitation programmes after breast cancer surgery remains variable. This study aims to evaluate a structured, individualised, and supervised early rehabilitation protocol, EMOVE-BCS-LaFe, applied in routine clinical practice during the first three months after surgery.\n\nThe main hypothesis is that the protocol is safe and feasible, with a low frequency of physiotherapy-related adverse events requiring urgent care or programme suspension for more than 7 days, and high completion and adherence rates. Secondary outcomes include improvements in shoulder mobility, pain, upper limb function, strength, overall functional capacity, satisfaction, and differences according to type of breast and axillary surgery.\n\nA prospective, single-centre, observational, single-arm cohort study will be conducted at HUIP La Fe. Adult women undergoing breast cancer surgery and referred to the programme will be consecutively included. The intervention includes preoperative education, therapeutic exercise initiated from the first postoperative day, home-based and supervised sessions, individualised progression, self-care recommendations, and early detection and management of axillary web syndrome and lymphoedema.\n\nFollow-up will extend from preoperative assessment to three months after surgery. Safety, adherence, programme completion, range of motion, pain, upper limb function, shoulder strength, functional capacity, and satisfaction will be assessed using adverse event records, adherence data, goniometry, VAS, QuickDASH, dynamometry, 30-second Sit-to-Stand test, CSQ-8, and specific satisfaction items. Data analysis will be descriptive, estimating proportions, clinical-functional changes over time, and exploratory differences according to surgery type.",[28],[69,70,71,72],"Breast cancer surgery","Postoperative rehabilitation","Early rehabilitation","Physical Therapy","NOT_YET_RECRUITING","2026-06-11",{"date":76,"type":44},"2026-06-16",{"date":78,"type":22},"2026-09-01",{"date":80,"type":22},"2027-08",{"name":82,"class":51},"Marta Aguilar-Rodriguez",{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100514745","phase-2-18f-fes-petmri-for-tailoring-treatment-of-luminal-a-and-lobular-breast-cancer-100514745","NCT05982496","18F FES-PET\u002FMRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer","18F-FES PET\u002FMRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer: a Phase II Prospective Cohort Study Evaluating the Performance of FES PET\u002FMRI in Axillary Staging Compared With Axillary Surgery","FESTA","Inclusion Criteria:\n\n* Female patients, age\\>= 18 yrs, diagnosed with primary or advanced breast cancer\n* LumA or ER-positive Lobular subtypes\n\n  * candidates to surgery as first treatment regardless of cN\n  * ER-positive Her2 negative BC with ki67\\>10%\n\nExclusion Criteria:\n\n* ER-negative tumors\n* Pregnancy;\n* Contraindication to PET;\n* Contraindication to MRI;\n* Claustrophobia;\n* Allergy to the MR contrast agent;\n* Severe renal insufficiency",{"count":92,"type":22},119,[94],"PHASE2","Study hypothesis is that combining the advantages of hybrid PET\u002FMRI and the high sensitivity\u002Fspecificity of 16-alpha-18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, the investigators could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lobular tumours.",[28,97,98,99,100],"Lobular Breast Carcinoma","PET\u002FMRI","Axillary Lymphadenopathy","Luminal A Breast Cancer","2026-06-09",{"date":103,"type":44},"2026-06-12",{"date":101,"type":44},{"date":106,"type":22},"2029-12-01",{"name":108,"class":51},"Università Vita-Salute San Raffaele",1,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":117,"minAge":61,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":109},"100608220","phase-1-eradicate-a-phase-ibii-study-of-elacestrant-plus-trastuzumab-deruxtecan-in-patients-with-cdk46-inhibitor-and-endocrine-resistant-hrher2-low-or-her2-ultralow-metastatic-breast-cancer-100608220","NCT07198724","ERADICATE: A Phase Ib\u002FII Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4\u002F6 Inhibitor and Endocrine-resistant HR+\u002FHER2-low or HER2-ultralow Metastatic Breast Cancer","ERADICATE","Inclusion Criteria:\n\n* Participants must have a histologically or cytologically confirmed diagnosis of HR+\u002FHER2-low metastatic or unresectable locally advanced breast cancer, defined as ER ≥ 10%, any PR in the most recent sample and HER2-low (IHC 1+ or IHC 2+ and ISH non-amplified) or HER2-ultralow (IHC 0 and any membranous staining on any prior primary or metastatic sample). Cutoff values for positive\u002Fnegative HER2 staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.76\n* Participants must have had prior CDK4\u002F6 inhibitor and may have any number of prior endocrine based therapies in the metastatic setting.\n* Participants may have progressed on up to 1 prior line of prior chemotherapy or ADC in the metastatic setting.\n* Participants must have measurable disease per RECIST 1.1 criteria. See Section 11 for the definition of measurable disease. Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n* Participants must have known ESR1 mutation status in tumor or ctDNA within 6 months of enrollment to the trial. Participants must have Guardant360 CDx testing for ESR1-mutation status if status has not been validated within 60 days of registration.\n* Women or men age ≥18 years are eligible.\n* ECOG performance status ≤ 2.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FµL\n  * Platelets ≥ 100,000\u002FµL\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 2 x ULN in patients with documented Gilbert's syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x institutional ULN (or \\\u003C 5 x ULN in patients with liver metastases)\n  * Creatinine ≤ 1.5 x institutional ULN OR\n  * Calculated creatinine clearance ≥ 45 mL\u002Fmin via the Cockcroft-Gault formula for participants with creatinine levels above institutional ULN\n  * Baseline LVEF ≥ 50% prior to registration, as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n  * Participants with a history of central nervous system (CNS) metastases are eligible if: Stable or untreated, asymptomatic brain metastases not needing immediate local therapy. For patients with untreated CNS lesions \\> 2.0 cm on screening contrast brain MRI, discussion with and approval from the Sponsor Investigator is required prior to enrollment.\n\n    1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator\n    2. Patients treated with CNS local therapy for newly identified lesions may be eligible to enroll if all of the following criteria are met: Time since WBRT is ≥ 14 days prior to first dose of treatment, time since SRS is ≥ 7 days prior to first dose of treatment, and time since surgical resection is ≥ 14 days\n* Postmenopausal women must be postmenopausal, which is defined as any of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, and estradiol in the postmenopausal range per local normal range\n  * Premenopausal women made postmenopausal through the use GnRH agonist prior to study entry are eligible and MUST remain on the GnRH agonist for the duration of protocol treatment.\n  * Status-post bilateral oophorectomy - After adequate healing post-surgery\n* Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are postmenopausal according to the definition in 3.1.10.\n* Women of child-bearing potential and men must agree to use adequate contraception at time of enrollment and for 4 months after the last dose of elacestrant or 7 months after the last dose of trastuzumab deruxtecan, whichever is later.\n* Participants must be able to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment with aatopoisomerase inhibitor antibody drug conjugate in any setting.\n* Prior treatment with an oral novel estrogen receptor degrader or modulator in the metastatic setting (SERD, SERM, PROTAC, or CERAN). Prior fulvestrant is allowed. A washout period of 7 days is required for any endocrine or targeted therapy. A washout period of 14 days is required for any chemotherapy.\n* Patients with known brain metastases that are symptomatic or that require therapy for symptom control are not eligible. Patients with stable or asymptomatic brain metastases are allowed. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 4 weeks before day 1 of study therapy will be excluded.\n* Receipt of any other investigational compound or device within 2 weeks of the first dose of treatment in this study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant or T-DXd.\n* History of (non-infectious) pneumonitis that required steroids or current ILD by imaging at screening.\n* Patients who are pregnant or breastfeeding, or who expect to become pregnant within the projected duration of the study.\n* Patients with active tuberculosis.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, uncontrolled diabetes mellitus, gastrointestinal disorders potentially affecting the absorption of elacestrant, inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or total gastric resection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Moderate or severe hepatic impairment (Child-Pugh B or C). Active hepatitis B or active hepatitis C infection. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. History of myocardial infarction, acute coronary syndrome or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the last six months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.\n* Patients with a history of different malignancy are ineligible, except for those who have been disease-free for at least three years and are deemed by the investigator to be at low risk for recurrence of the prior malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.","ALL",{"count":119,"type":22},65,[121,94],"PHASE1","The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4\u002F6 inhibitor and endocrine therapy.\n\nThe names of the study drugs involved in this study are:\n\n* Elacestrant (a type of selective estrogen receptor degrader)\n* Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)",[124,125,126,127,28],"Metastatic Breast Cancer","HER2 Low Breast Carcinoma","HER2-negative Breast Cancer","Breast Cancer",[124,125,126,127,28,129,130,131],"HR+\u002FHER2-low Breast Cancer","HR+\u002FHER2-ultralow Breast Cancer","Endocrine-resistant Breast Cancer","2026-06-08",{"date":134,"type":44},"2026-06-10",{"date":136,"type":44},"2025-11-17",{"date":138,"type":22},"2038-06-01",{"name":140,"class":51},"Kristina A. Fanucci",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":109},"100593455","anatomical-landmarks-for-chest-wall-perforators-used-for-partial-breast-reconstruction-100593455","NCT07006662","Anatomical Landmarks for Chest Wall Perforators Used for Partial Breast Reconstruction","Anatomical Landmarks for Chest Wall Perforators Used for Partial Breast Reconstruction (LaPBrecon)","(LaPBrecon)","Inclusion Criteria:\n\n* Patients undergoing elective breast surgery\n* Age ≥ 18 years\n* Female\n* BMI ≤ 30 kg\u002Fm2\n* Willing and able to give fully informed consent,\n* Willing and able to comply with the study procedures\n\nExclusion Criteria:\n\n* Pregnant patients\n* Previous bilateral Breast or axillary surgery\n* Undergoing bilateral oncoplastic procedure or requiring bilateral pre-operative marking\n* Undergoing breast surgery requiring pre-operative marking of some of the landmarks and has had contralateral breast or axillary surgery in the past\n* Surgery planned within 24 hours of screening for eligibility\n* Known history of allergy or contact dermatitis to ultrasound gels",{"count":150,"type":22},20,"OBSERVATIONAL","The aim of this 6-month proof-of-concept study is to map out the chest wall perforators in relation to anatomical landmarks for partial breast reconstruction.",[28],{"date":101,"type":44},{"date":156,"type":22},"2026-07-01",{"date":158,"type":22},"2027-12-01",{"name":160,"class":51},"University Hospitals of North Midlands NHS Trust",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":109},"100602176","transcranial-magnetic-stimulation-for-chemotherapy-induced-peripheral-neuropathy-in-breast-and-gynecologic-cancer-survivors-100602176","NCT07120100","Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy in Breast and Gynecologic Cancer Survivors","Repetitive Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Breast and Gynecologic Cancer Survivors: A Pilot Study","rTMS for CIPN","Inclusion Criteria:\n\n* Female subjects aged ≥ 18 years.\n* Histologically confirmed breast or gynecologic cancer.\n* Developed neuropathic pain with the initiation of or within one month after completion of treatment with anti-neoplastic agents from the following class:\n\n  * Platinum-based drugs\n  * Taxanes\n  * Vinca alkaloids\n* Pain score 4 or more on the Pain Numeric Rating Scale (PNRS).\n* Score 3 or more on the Douleur Neuropathique 4 (DN-4) questionnaire.\n* Subjects must have failed at least one standard-of-care neuropathic medication.\n\n  \\--- Note: Failure is defined as discontinuation of the standard-of-care neuropathic pain medication due to intolerable side effects or lack of analgesic benefit after continuing the medication for at least 6 weeks.\n* Subjects who are currently on neuropathic medication must have been on a stable dose for at least 6 weeks prior to enrollment.\n\n  \\-- Note: Additional washout periods for other pain medications may be needed and will be determined by the Investigator.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Subjects of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Evidence of recurrent breast or gynecologic cancer at the time of enrollment.\n* Current or planned treatment with chemotherapy.\n\n  --Note: Other anti-cancer treatments (e.g. hormone therapy and targeted therapies) are allowed at the Investigator's discretion.\n* History of seizure, epilepsy, or other conditions that would, in the opinion of the investigator, negatively impact the patient's safety or ability to participate in the study.\n* Presence of neuropathic pain unrelated to systemic cancer therapy, including but not limited to: painful diabetic neuropathy, HIV-induced neuropathy, neuropathic pain from radiation therapy and underlying cancer\u002Fother medical conditions.\n* Presence of implantable devices including spinal cord stimulators, dorsal root ganglion stimulators, deep brain stimulators, cochlear implants, intrathecal pain pumps, and intracranial metallic objects which are incompatible with rTMS administration in the opinion of the treating investigator.\n* Subjects on medications that, in the opinion of the investigator, significantly lower seizure threshold will be excluded.\n* Any condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* History of recent suicide attempt or active suicidal ideation that, in the opinion of the investigator, presents an increased risk for study participation\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Enrollment in another study that, in the opinion of the investigator, would negatively impact study participation or cause undue burden for the subject.",{"count":170,"type":22},19,[65],"The goal of this study is to evaluate the change in pain scores among patients with chemotherapy-induced peripheral neuropathy after receiving treatment with repetitive transcranial magnetic stimulation (rTMS).",[28,174],"Gynecologic Cancer","2026-05-29",{"date":177,"type":44},"2026-06-02",{"date":179,"type":44},"2025-08-27",{"date":181,"type":22},"2028-09-15",{"name":183,"class":51},"University of Utah",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":18,"minAge":191,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100601873","exercise-therapy-and-cognitive-behavioural-therapy-for-fatigue-in-female-cancer-patients-in-singapore-100601873","NCT07116161","Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore","Pilot Study of Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore","Inclusion Criteria:\n\nPrimary cohort (N=90):\n\n1. Female\n2. ≥21 years of age\n3. Stage I-III breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status\n4. Completed surgery\n5. Completed adjuvant chemotherapy, if indicated\n6. Reported fatigue (One-item fatigue scale score ≥ 4)\n7. Ability to read and communicate in English\n8. Willing to provide informed consent for the study participation\n\nExploratory cohort (N=10):\n\n1. Female\n2. ≥21 years of age\n3. Stage IV breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status\n4. Completed surgery\n5. Currently receiving systemic therapy (e.g. endocrine therapy, chemotherapy, targeted therapy or immunotherapy)\n6. Reported fatigue (One-item fatigue scale score ≥ 4)\n7. Ability to read and communicate in English\n8. Willing to provide informed consent for the study participation\n\nExclusion Criteria for both cohorts:\n\n1. Pregnant or lactating\n2. Presence of dementia or major psychiatric disease\n3. Deemed medically unsuitable by medical team for low to moderate intensity exercise\n4. Unable or unwilling for tele-counselling sessions\n5. Uncontrolled pain or undiagnosed pain\n6. Low blood counts: Hb \\\u003C8.0, Platelet \\\u003C50K, ANC \\\u003C1\n7. Electrolyte imbalances: K \\\u003C3.0, Na \\\u003C130\n8. Cardiovascular diseases, including but not limited to: LVEF \\\u003C35%, uncontrolled arrhythmias, severe coronary artery disease, severe valvular heart disease, uncontrolled hypertension etc. not cleared by a cardiologist\n9. Active infection\n10. Currently engaged in moderate to vigorous physical activity","21 Years",{"count":193,"type":22},100,[65],"The purpose of this research study is to investigate the acceptability, feasibility, and effectiveness of exercise therapy and cognitive behavioral therapy (CBT) in improving fatigue levels and breast cancer treatment adherence in breast cancer patients.",[197,28],"Fatigue",[199,200],"Exercise Therapy","Cognitive Behavioural Therapy","2026-05-27",{"date":175,"type":44},{"date":204,"type":44},"2025-07-14",{"date":206,"type":22},"2027-12-31",{"name":208,"class":51},"National Cancer Centre, Singapore",4,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":19,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":238,"locationsCount":109},"100555908","preventing-breast-cancer-therapy-related-cardiovascular-toxicity-with-a-daily-adapted-program-with-mhealth-support-100555908","NCT06518200","Preventing Breast Cancer Therapy-related Cardiovascular Toxicity With a Daily-adapted Program With Mhealth Support","ATOPE-PRO: Effects on the Prevention of Breast Cancer Therapy-related Cardiovascular Toxicity of a Daily-adapted and Individualized Program With Support From a Mobile Application","ATOPE-PRO","Inclusion Criteria:\n\n* Recently diagnosed with stage I-III breast cancer\n* Treatments predisposing to cardiotoxicity (anthracyclines, targeted therapies, radiotherapy)\n* Signed informed consent form\n* Medical authorisation to participate\n* Smartphone user level\n\nExclusion Criteria:\n\n* Patient underwent previous cancer treatments.\n* Patients were previously diagnosed with cancer\n* Pregnant patients. Patients performing other type of therapeutic exercise at diagnosis time with an intake \\>or = to 150 moderate-intensity or 75 min of vigorous-intensity a day\n* Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis \\>70%, metastasis etc.).",{"count":219,"type":22},102,[65],"ATOPE-PRO, was developed with the intention of consolidating the integration of an innovative system for the prevention of cancer therapy-related cardiovascular toxicity (CTR-CVT) in the continuum care of women with breast cancer in health services. It is a step further towards personalized medicine by optimizing the already available tools and integrating artificial intelligence. Breast cancer survival increases every year, a situation that poses new challenges for health professionals. The European Society for Medical Oncology, a reference in Europe, has just highlighted the need to anticipate to and prevent sequelae derived from the disease and its treatments. This, in addition to having a positive impact on improving the quality of life of people suffering from this disease, would mean a reduction in the risk of recurrence, the appearance of other tumors and other diseases, and death from cancer or other causes, which have a personal impact and represent an overload of the healthcare system. To this end, ATOPE- PRO aims to optimize and refine tools already developed in the previous project (ATOPE, Pl18\u002F01840), integrating artificial intelligence to help identify CTR-CVT, risk profiles, and effective and safe doses (at a clinical level) early on, implementing the program in a longer term, and transferring the results to the social sector (social level). The project has 4 stages: Phase 0 or start-up (to make improvements and analyse usability); Phase 1 for piloting and optimization; Phase 2, to verify efficacy (randomized controlled clinical trial) and Phase 3, in which a deep analysis will be performed and future projects will be conceived.",[28],[224,225,226,227,228,229,230,231],"Breast Neoplasms","Cancer therapy-related cardiovascular toxicity","Physical Exercise","Prevention","Quality of life","Rehabilitation","Telemedicine","Health related lifestyle","2026-04-30",{"date":234,"type":44},"2026-05-06",{"date":78,"type":22},{"date":237,"type":22},"2028-12-31",{"name":239,"class":51},"Universidad de Granada",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":18,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":252,"studyType":151,"phases":4,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":109},"100558783","evaluation-of-safety-of-acellular-dermal-matrixadm-in-breast-reconstruction-100558783","NCT06555614","Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction","Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants","ADM","Inclusion Criteria\n\nProspective Subjects (Test Group):\n\n* Female patients aged 19 to 79 years\n* Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer\n* Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits\n\nRetrospective Medical Record Collection (Control Group):\n\n* Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital\n* Availability of medical records between March 1, 2021, and March 31, 2024\n\nExclusion Criteria\n\nProspective Subjects (Test Group):\n\n\\- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments)\n\nRetrospective Medical Record Collection (Control Group):\n\n\\- Patients with no recorded follow-up visits after application of the acellular dermal matrix","19 Years","79 Years",{"count":251,"type":22},120,"12 Weeks","The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.",[28,255],"Breast Reconstruction","2026-04-23",{"date":258,"type":44},"2026-04-28",{"date":260,"type":44},"2024-06-13",{"date":262,"type":22},"2027-02-28",{"name":264,"class":265},"DOF Inc.","INDUSTRY",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":273,"sex":18,"minAge":274,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":4},"100547253","physical-activity-for-adults-in-the-ontario-breast-screening-program-100547253","NCT06405568","Physical Activity for Adults in the Ontario Breast Screening Program","Support for Physical Activity for Adults Registered in the Ontario Breast Screening Program: A Randomized Controlled Trial","Inclusion Criteria:\n\n* English- and French-speaking adults enrolled in the Ontario Breast Screening Program;\n* Aged 30-69 years;\n* Assigned female sex at birth;\n* Be at high risk for breast cancer as identified through Category A or B, after genetic assessment: (a) Category A individuals meet ≥1 of the following criteria: (i) known carrier of a gene mutation (e.g., BRCA1, BRCA2), (ii) first degree relative of a carrier of a gene mutation (e.g., BRCA1, BRCA2), received genetic counselling but declined genetic testing, (iii) previously assessed as having ≥25% lifetime risk of breast cancer on basis of family history, or (iv) received chest radiation before age 30 and ≥ 8 years previously.\n\n  (b) Category B individuals meet ≥1 of the following criteria: (i) first degree relative of a carrier of a gene mutation (e.g., BRCA1, BRCA2), has not had genetic counselling or testing, (ii) a personal or family history of ≥1 of the following: ≥2 cases of breast cancer and\u002For ovarian cancer in closely related blood relatives, bilateral breast cancer, both breast cancer and ovarian cancer in the same individual, breast cancer at age ≤35 years, invasive serous ovarian cancer, breast cancer and\u002For ovarian cancer in Ashkenazi Jewish families, an identified gene mutation (e.g., BRCA1, BRCA2) in any blood relative, male breast cancer.\n\nExclusion Criteria:\n\nIndividuals self-reporting\n\n* \\>150 minutes of moderate-to-vigorous intensity physical activity in the past week;\n* no access to an internet connected device;\n* a condition preventing physical activity (e.g., uncontrolled hypertension)",true,"30 Years","69 Years",{"count":277,"type":22},200,[65],"There is \"strong\" evidence that physical activity (PA) can reduce the risk of breast cancer (Bernstein, 2009; Kehm et al., 2020), which is important for individuals at higher-than-average risk due to their family history or genetic susceptibility. PA can also enhance quality of life (QoL), fitness, and surrogate markers (e.g., weight) linked to cancer prognosis (Ligibel et al., 2019; Patel et al., 2019). Despite this evidence, most adults are insufficiently active, meaning they do not meet Canadian recommendations of at least 150 minutes of PA each week (Statistics Canada, 2020). This study aims to develop materials that can help increase the number of adults at higher-than-average risk who meet PA recommendations, alongside improving QoL and body mass index (BMI; a measure of one's body weight-height ratio). Participants will include individuals assigned female at birth, aged 30-69 years, at high-risk of breast cancer registered in the Ontario Breast Screening Program who will be randomly assigned to receive (1) the intervention, which includes a copy of PA recommendations (Canadian Society for Exercise Physiology \\[CSEP\\] recommendations for adults plus content spotlighting PA benefits) plus a PA motivation package featuring three online webinars (explaining PA benefits and how to get started), digitized PA materials (providing evidence-based tools to modify behaviour), and a digitized logbook (to track PA) or (2) only a copy of PA recommendations.",[28,281],"Physical Inactivity",[283,284,285],"Healthcare providers","Physical activity","Breast cancer",{"date":287,"type":44},"2026-04-29",{"date":289,"type":22},"2026-05-01",{"date":291,"type":22},"2028-05-01",{"name":293,"class":51},"University of Ottawa",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":273,"sex":18,"minAge":191,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":109},"100296293","effects-of-chemotherapy-on-cognitive-function-in-breast-cancer-patients--non-cancer-control-subjects-with-optional-sub-study-research-brain-mri-100296293","NCT03137095","Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI","Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants - Optional Sub-Study: Research Brain MRI","Inclusion Criteria, Breast Cancer Patient Participants:\n\n* Females with a diagnosis of invasive non-metastatic breast cancer (stage I-IIIC)\n* Scheduled to begin a course of chemotherapy with Adriamycin and Cytoxan\n* Chemotherapy naïve\n* Able to speak and read English\n* 21 years or older\n* Give written informed consent\n\nExclusion Criteria, Breast Cancer Patient Participants:\n\n* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness\n* Must not be diagnosed with a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)\n* Must not have any Central Nervous System disease (e.g., movement disorder, multiple sclerosis)\n* Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms\n* Must not be scheduled to receive concurrent radiation treatment while receiving chemotherapy.\n* Must not be colorblind\n\nInclusion Criteria, Control Participants:\n\n* Must be female and within 5 years of the age of the subject receiving chemotherapy\n* Able to speak and read English\n* Give written informed consent\n* 21 years or older\n\nExclusion Criteria, Control Participants:\n\n* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness\n* Must not be diagnosed with a neurodegenerative disease (e.g. Alzheimer's disease, Parkinson's disease)\n* Must not have Central Nervous System disease (e.g., movement disorder, multiple sclerosis)\n* Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms\n* Must not have been diagnosed with cancer or previously have received chemotherapy\n* Must not be colorblind\n\nFor optional sub-study: MR safety assessed via Rochester Center for Brain Imaging Magnetic Resonance (MR) Safety Screening Form to confirm eligibility to participate",{"count":302,"type":22},150,"Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.",[305,28],"Cancer Related Cognitive Difficulties","2026-04-22",{"date":308,"type":44},"2026-04-24",{"date":310,"type":44},"2017-02-20",{"date":312,"type":22},"2027-07-31",{"name":314,"class":51},"University of Rochester",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":331,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":343},"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",{"count":324,"type":22},270,[65],"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.",[127,328,28,329,330],"Stage III Breast Cancer","Stage I Breast Cancer","Stage II Breast Cancer",[127,328,330,329,332,333,334],"Exercise Intervention","Nutrition Intervention","Supportive Care","2026-04-21",{"date":256,"type":44},{"date":338,"type":44},"2023-03-20",{"date":340,"type":22},"2027-02-01",{"name":342,"class":51},"Dana-Farber Cancer Institute",3,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":352,"enrollmentInfo":353,"targetDuration":355,"studyType":151,"phases":4,"briefSummary":356,"conditions":357,"keywords":363,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":109},"100631831","atusa-ultrasound-diagnostic-imaging-for-breast-lesions-evaluation-audible-100631831","NCT07505797","ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)","ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE), a Case Collection Registry for 3D Breast Automated Ultrasound Using ATUSA System as Well as Other Breast Imaging Modalities.","AUDIBLE","Inclusion Criteria:\n\n1. Provide written informed consent through a signed and dated consent form.\n2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.\n3. Be female, aged 18 to 94 years (inclusive).\n4. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.\n\nExclusion Criteria:\n\n1. Active skin lesions (open wounds or unhealed sores) on either breast.\n2. Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.\n3. Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.\n4. Previous bilateral mastectomy.\n5. Physical inability to maintain a supine position for 30 minutes.\n6. Breast anatomy incompatible with ATUSA device specifications.\n7. Recent (within 12 months) breast surgery or cancer treatment.\n8. Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.\n9. Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.","94 Years",{"count":354,"type":22},800,"7 Days","AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes.\n\nThe study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden.\n\nThis study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.",[127,358,359,224,360,28,361,362],"Benign Breast Condition","Breast Fibroadenoma","Breast Disease","Breast Pain","Breast Cancer Invasive",[30,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379],"breast lesions","dense breasts","invasive breast carcinoma","benign breast disease","ATUSA","Automated Breast Utrasound","ABUS","Ultrasound breast imaging","multimodality imaging","ultrasound","registry","image quality","AI","AI Model Training","medical device","iSono Health","2026-03-26",{"date":382,"type":44},"2026-04-01",{"date":384,"type":44},"2025-12-16",{"date":386,"type":22},"2026-12-31",{"name":388,"class":265},"iSono Health, Inc.",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":403,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100444813","phase-3-long-term-outcomes-of-lidocaine-infusions-for-post-operative-pain-lolipop-trial-100444813","NCT05072314","Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial","LOLIPOP","Inclusion Criteria:\n\n* Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected primary breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants)\\*. \\* this specifically excludes patients undergoing surgery for locoregional recurrence\n* American Society of Anaesthesiologist (ASA) physical scale 1-3\n\nExclusion Criteria:\n\n* Mastectomy or breast conserving surgery with add on procedures e.g laparoscopic salpingectomy\n* Where surgery is being performed for locoregional recurrence of breast cancer\n* Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm (at diagnosis prior to any tumor locating procedures)\n* Re-excision procedures where the margins at the index surgery have been deemed insufficient\n* When immediate autologous reconstruction surgery is planned\n* Where delayed autologous reconstruction surgery on the operative breast within one year is planned\n* Planned use of regional analgesia infusions\n* Impaired cognition\n* Pregnant or lactating females\n* Transgender patients\n* Known metastatic disease\n* History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia\n* History of epilepsy\n* Baseline heart rate \\< 50 bpm or systolic blood pressure \\< 100mmHg.\n* Acute coronary event in the last three months\n* Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated\n* Abnormal serum potassium concentration (based upon site laboratory reference ranges)\n* Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)\n* Medications within the last 7 days which are known \u002F suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)\n* Cardiac Failure (any documented heart failure at peroperative assessment or GP records)\n* Severe Renal Failure (Creatinine Clearance of less than 30ml\u002Fmin or dialysis dependent)\n* Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches",{"count":397,"type":22},4300,[25],"The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.",[127,28,401,402],"Breast Conserving Surgery","Mastectomy",[404,405,406],"Anaesthesia","Local Anaesthesia","Chronic Post Surgical Pain","2026-03-22",{"date":409,"type":44},"2026-03-25",{"date":411,"type":44},"2022-07-27",{"date":413,"type":22},"2028-07",{"name":415,"class":51},"Monash University",47,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":109},"100372720","xenografts-development-from-surgical-tumor-samples-of-patients-with-triple-negative-or-luminal-b-breast-cancer-100372720","NCT04133077","Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer","A Prospective Study of Xenografts Development From Samples Taken From Surgical Specimens of Patients With Triple Negative or Luminal B Breast Cancer","XenoBreast","Inclusion Criteria:\n\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2\n* Signature of the participation consent to the study,\n* Affiliation to a social security scheme\n* Major woman with:\n\n  * metastatic triple-negative (TN) breast cancer, histologically proven before treatment and high grade, receiving neoadjuvant chemotherapy and having, after treatment, a breast residue of at least 15 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of neoadjuvant treatment\n  * metaplastic triple-negative (TN) breast cancer, histologically proven before treatment and high grade, treated by primary surgery with a tumor size of at least 15 mm on the specimen.\n  * an inflammatory TN breast cancer (T4d), histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a breast residue of at least 15 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.\n  * non-metaplastic or inflammatory TN breast cancer, histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a mammary residue of at least 30 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.\n  * Luminal B breast cancer (LB), histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a mammary residue of at least 30 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.\n  * histologically proven metastatic TN or metastatic breast cancer with an operable metastasis whose residual size, after chemotherapy, is at least 10 mm on the specimen. Residual metastasis will be at least 15 mm on imaging.\n* Patients in a metastatic situation can be included regardless of the therapeutic line.\n\nExclusion Criteria:\n\n* Pregnant woman\n* Patient deprived of liberty by court or administrative decision\n* In neoadjuvant situation: no neoadjuvant treatment by radiotherapy or hormone therapy\n* Refusal to participate in the study",{"count":426,"type":22},85,[65],"Patient derived xenografts (PDX) from mammary tumors are usually made from metastatic tumors. Indeed, PDX from primitive mammary tumors or after neoadjuvant treatment are still rare. However, the realization of such PDX (from primitive mammary tumors or after neoadjuvant treatment) would make it possible to have a better knowledge of the tumor heterogeneity to the therapeutic response, to explore the models of tumor evolution during metastatic progression and also observe the mechanisms of tumor resistance in the case of non-metastatic tumors. It therefore seems necessary to develop PDX from primitive tumors in order to observe firstly the success rate of PDX; on the other hand, the drift of the initial heterogeneity, measured by comparison of the histomolecular profile of the tumors with that of the PDXs. It aims to develop xenografts from tumor samples from surgical specimens of patients with triple negative or luminal B breast cancer.",[28],[431],"PDX","2026-03-18",{"date":434,"type":44},"2026-03-19",{"date":436,"type":44},"2021-11-19",{"date":438,"type":22},"2030-08-31",{"name":440,"class":51},"Centre Jean Perrin",{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":462,"locationsCount":109},"100440843","phase-2-microbiome-and-association-with-implant-infections-100440843","NCT05020574","Microbiome and Association With Implant Infections","Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction","Inclusion Criteria:\n\n1. Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.\n2. Age \\>= 18 years\n3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement\n4. Ability to understand a written informed consent document, and the willingness to sign it\n5. At least 4 weeks post-completion of chemotherapy or radiation therapy.\n\nExclusion Criteria:\n\n1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study\n2. Pregnant or breastfeeding\n3. Patients who have taken antibiotics within 90 days of the consent date\n4. Patients who have taken probiotics within 90 days of the consent date\n5. Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study\n6. Male patients",{"count":277,"type":22},[94],"The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and\u002For Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.",[127,28,452],"Genetic Predisposition to Disease",[454,455,456,255,402],"Post-Surgical Antibiotics","Breast Implant Infections","Breast Microbiome","2026-03-16",{"date":432,"type":44},{"date":460,"type":44},"2021-09-28",{"date":386,"type":22},{"name":463,"class":51},"University of California, San Francisco",{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":472,"targetDuration":474,"studyType":151,"phases":4,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":209},"100328905","gammapod-registry-and-quality-of-life-nomogram-100328905","NCT03562273","GammaPod Registry and Quality of Life Nomogram","Tumor Bed Boost Using a Breast Specific Radiosurgery Device, The GammaPodTM: Registry Study and Evaluation of Quality of Life With Development of Sizing Nomogram","GCC 1876","Inclusion Criteria:\n\n* The patient must sign consent for study participation.\n* The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy.\n* The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).\n* Patients with involved lymph nodes are candidates for the study.\n* Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin).\n* The greatest dimension of the tumor is less than 4cm before surgery.\n* Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation.\n* Age 18 years and older.\n* Women of childbearing potential (pre-menopausal defined as having a menstrual period within the past 1 year) must have a negative serum pregnancy test or complete a pregnancy waiver form per institutional policy.\n* The surgical cavity is clearly visible on CT images. Of note, clips are not required but recommended.\n* The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch.\n* The patient must be less than 6'6\" in height.\n* The patient must feel comfortable in the prone position.\n* Diagnosis of prior contralateral breast cancer is allowed.\n* Diagnosis of synchronous bilateral cancers is allowed. In this case if bilateral boosts are required, a patient would not have both treatments on the same day.\n* Oncoplastic reduction surgery is allowed if the lumpectomy cavity can be clearly visualized.\n\nExclusion Criteria:\n\n* Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).\n* Prior radiation therapy to that breast or that hemi thorax.\n* Unable to fit into the immobilization breast cup with an adequate seal.\n* Male gender.\n* Patient cannot comfortably be set up in the prone position (i.e. physical disability)\n* Unable to fit into the breast immobilization device due to breast size or other anatomical reason.\n* Mastectomy is the surgery performed.\n* Patient has received prior radiotherapy to the involved breast.\n* Tumor bed is less than 3 mm from the skin surface.\n* Greater than 50% of the target volume is above the upper border of the table.\n* Patients with skin involvement, regardless of tumor size.\n* Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.\n* Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.\n* Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.\n* Patients with breast implants\u002Ftissue expanders or flap reconstruction.",{"count":473,"type":22},160,"1 Year","This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod.",[28],[478,479,480],"Breast Nomogram","Breast Cancer Quality of Life","GammaPod Registry","2026-02-18",{"date":483,"type":44},"2026-02-20",{"date":485,"type":44},"2019-01-03",{"date":487,"type":22},"2030-12",{"name":489,"class":51},"University of Maryland, Baltimore",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":497,"maxAge":498,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":501,"briefSummary":502,"conditions":503,"keywords":504,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":515,"locationsCount":109},"100557971","cognitive-rehabilitation-following-breast-cancer-treatment-100557971","NCT06545045","Cognitive Rehabilitation Following Breast Cancer Treatment","Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer","Inclusion Criteria:\n\n* self-reported CRCI (Global Rating of Cognition dysfunction as \"Moderately\" \"Strongly \"or \"Extremely\" AND a Cognitive Failures Questionnaire1 (CFQ) score \\>30)\n* completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater than 3 years prior to participation\n* able to read, write, and speak English fluently\n* able to provide valid informed consent\n* have a life expectancy of greater than 6 months at time of enrollment\n* on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants)\n\nExclusion Criteria:\n\n* prior cancer diagnoses of other sites with evidence of active disease within the past year\n* active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of \\\u003C23 on the Montreal Cognitive Assessment (MoCA)\n* severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21)\n* history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)\n* conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia)\n* blue-yellow colorblindness\n* pregnancy\n\nThe screening methods identified in parentheses next to appropriate inclusion\u002Fexclusion criteria will be used to verify appropriate selection of study participants.","20 Years","75 Years",{"count":500,"type":22},50,[65],"The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, cognition, and quality of life in breast cancer survivors with cancer-related cognitive impairment (CRCI). The other goal of this proposed project is to examine the effects of CO-OP on resting (rsFC)- and task-state functional connectivity as compared to an inactive control group.",[28],[505,127,506,507,508],"Cancer","Cognition","Metacognition","Activities of daily living","2026-02-17",{"date":511,"type":44},"2026-02-19",{"date":513,"type":44},"2024-10-31",{"date":43,"type":22},{"name":516,"class":51},"University of Missouri-Columbia",{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":109},"100558513","guided-digital-self-hypnosis-solution-for-managing-hot-flashes-in-patients-undergoing-adjuvant-hormone-therapy-100558513","NCT06552091","Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy","HYBOU","Inclusion Criteria:\n\n* Adult patient,\n* WHO ≤ 2,\n* Patient who is premenopausal, perimenopausal, or postmenopausal at diagnosis,\n* Patient being treated for non-metastatic breast cancer,\n* Ongoing adjuvant endocrine therapy, with or without concomitant anti-CDK 4\u002F6 targeted therapy,\n* Patient reporting at least 50 hot flashes per week or at least 7 hot flashes per day\n* Patient has a computer device capable of accessing the self-hypnosis program link,\n* Information provided and informed consent signed,\n* Patient affiliated with the social security system.\n\nExclusion Criteria:\n\n* Male,\n* Patient with hearing impairments,\n* Patient with psychotic and\u002For cognitive disorders As assessed by the clinician,\n* Patient who does not understand the French language,\n* Patient not diagnosed with non-metastatic breast cancer,\n* Patient not undergoing anti-aromatase treatment,\n* Patient reporting fewer than 50 hot flashes per week or fewer than 7 hot flashes per day,\n* Prior participation in a hypnosis or self-hypnosis program before inclusion,\n* Patient participating in a therapeutic program related to hot flashes,\n* Patient already included in another therapeutic trial on the same topic,\n* Patient already included in another therapeutic trial with an experimental drug,\n* Pregnant or breastfeeding woman,\n* Patient deprived of liberty (including guardianship and curatorship).",{"count":525,"type":22},76,[65],"Patients treated for breast cancer with hormone therapy (HT) suffer from hot flashes. This side effect impacts treatment adherence. Indeed, approximately 50% of women take less than 80% of the prescribed dose, and up to 50% abandon their treatment before the fifth year of prescription, significantly increasing the risk of recurrence. Moreover, these hot flashes strongly impact the quality of life. According to the CANTO study, these hot flashes can persist up to two years after diagnosis, affecting social relationships, return to work, and physical and mental health.\n\nSome side effects resulting from HT (sleep disturbances, fatigue, hot flashes) could be alleviated by a non-pharmacological approach involving the patient.\n\nOur hypothesis is that a non-pharmacological solution, such as the use of self-hypnosis, could reduce hot flashes and the side effects related to HT or the perception thereof in patients treated for breast cancer. Consequently, this could improve the quality of life and lead to better treatment adherence.\n\nThe principal objective is to evaluate the effect of daily guided self-hypnosis sessions in reducing hot flashes in patients with non-metastatic breast cancer receiving anti-aromatase hormone therapy.\n\nThe secondary objectives are to evaluate :\n\n* Patient adherence to guided self-hypnosis via a digital solution\n* Quality of life\n* Sleep quality\n* Satisfaction with care\n* Usability of the digital tool\n\nThe originality of this clinical trial is the proposal of self-hypnosis sessions over three weeks with three different themes using a digital solution.",[28],[30,530,531,532,533],"non-metastatic","hormone therapy","hot flashes","self-hypnosis","2026-02-12",{"date":509,"type":44},{"date":537,"type":44},"2024-10-17",{"date":539,"type":22},"2027-02-17",{"name":541,"class":51},"Institut de Cancérologie de Lorraine",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":273,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":567},"100611556","conformal-ablative-radiotherapy-in-older-women-carmen-with-breast-cancer-undergoing-non-operative-management-100611556","NCT07242118","Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management","CARMEN","Inclusion 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 greater than or equal to age 65 years\n* Diagnosis of invasive carcinoma of breast undergoing non-operative management\n* Previously untreated OR previously treated with primary ET or chemotherapy, with either stable or progressive localized disease.\n* Tumor measuring ≤5 cm (cT1-T2) and clinically node negative\n* Diagnostic biopsy ER-positive (greater than or equal to 10% ER by immunohistochemistry staining)\n* Diagnostic biopsy HER2-negative according to ASCO\u002FCAP guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization)\n* Suitable for SABR as deemed by the treating radiation oncologist\n* Participants 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\n* Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial\n\nExclusion Criteria:\n\n* Active treatment with systemic chemotherapy for breast cancer. Subjects will need to stop any breast cancer chemotherapy agent before enrollment to be included study.\n* Multicentric tumor.\n* Clinical or imaging evidence of distant metastases.\n* Prior ipsilateral breast or thoracic radiation.\n* Autoimmune conditions with associated radiation risks.",{"count":550,"type":22},18,[65],"This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement. Eligible patients, including those previously on endocrine therapy, receive 5 SABR treatments, followed by monitoring of quality of life and assessment of treatment-related toxicity.",[28],[555,556,557],"Geriatric","ER-positive","HER2-negative","2026-02-06",{"date":560,"type":44},"2026-02-10",{"date":562,"type":44},"2025-11-04",{"date":564,"type":22},"2027-10",{"name":566,"class":51},"University of Kansas Medical Center",2,{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":109},"100523788","breast-cancer-resiliency-through-exercise-program-b-rep-100523788","NCT06100263","Breast Cancer Resiliency Through Exercise Program (B-REP)","Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study","B-REP","Inclusion Criteria:\n\nWomen will be eligible if they meet the following criteria:\n\n* self-identify as Black or African American or Afro-Latina\u002Fe;\n* are ≥18 years old;\n* have a confirmed diagnosis of breast cancer, Stage I to IIIA;\n* have completed primary active treatment (i.e., surgery, chemotherapy, and radiation) within 5 years prior to study start where concomitant hormonal therapy is acceptable;\n* are not meeting current cancer-specific resistance exercise guidelines of ≥ 2 times per week; and\n* are able to speak and understand English.\n\nExclusion Criteria:\n\n* metastatic disease;\n* medical reason that precludes them from increasing current exercise levels;\n* planned elective surgery during study period;\n* pregnant or plans to become pregnant during the study period;\n* plans to move out of United States during the study period; (the rationale for this exclusion is that it will be difficult to conduct the in-person assessments if a participant leaves the United States);\n* current enrollment in another exercise trial; and\u002For\n* inability to pass exercise pre-screening or receive physician consent to increase current physical activity levels.",{"count":577,"type":22},75,[65],"The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and waitlist control among 30 Black breast cancer survivors",[28],"2026-02-05",{"date":560,"type":44},{"date":584,"type":44},"2024-05-28",{"date":586,"type":22},"2026-12",{"name":588,"class":51},"University of Michigan Rogel Cancer Center",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":18,"minAge":497,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":600,"conditions":601,"keywords":603,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":109},"100524957","exert-bch-exercise-regimen-to-improve-muscle-mass-after-treatment-of-breast-cancer-100524957","NCT06115486","EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer","EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy","Inclusion Criteria:\n\nAge 20-89 years\n\n* Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast\n* Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.\n\nExclusion Criteria:\n\n* Any current treatment with cytotoxic chemotherapy for breast cancer\n* Inability to safely engage in group sessions of resistance training as deemed by study PI\n* Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training","89 Years",{"count":598,"type":22},30,[65],"The purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.",[127,602,28],"Breast Carcinoma in Situ",[505,604,605,606],"Carcinoma in Situ","Hypertrophy","Exercise","2026-02-02",{"date":609,"type":44},"2026-02-04",{"date":611,"type":44},"2024-01-09",{"date":613,"type":22},"2027-01",{"name":615,"class":51},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":273,"sex":18,"minAge":622,"maxAge":623,"enrollmentInfo":624,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":626,"conditions":627,"keywords":635,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":109},"100618429","validation-of-the-oncoliq-test-for-the-early-detection-of-breast-cancer-100618429","NCT07331506","Validation of the Oncoliq Test for the Early Detection of Breast Cancer.","Inclusion Criteria:\n\nGroup 1 - Breast Cancer:\n\nAge between 40 and 70 years Diagnosis of breast cancer at any stage No prior surgical treatment No prior antineoplastic treatment Pathology report available at the time of enrollment Signed informed consent\n\nGroup 2 - No Cancer (Control):\n\nAge between 50 and 70 years No diagnosis or personal history of any type of cancer Digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2) Signed informed consent\n\nExclusion Criteria:\n\nRefusal to sign the informed consent Communication issues that hinder understanding (hearing loss, blindness, intellectual disability, or dementia) Venipuncture for blood collection impracticable or posing a risk Personal history of previous cancer","40 Years","70 Years",{"count":625,"type":22},300,"Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today.\n\nMicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection.\n\nThe research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology.\n\nThe objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.",[628,629,28,630,631,632,633,634],"Breast Cancer Detection","Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Breast Cancer - Ductal Carcinoma in Situ (DCIS)","Breast Cancer - Infiltrating Ductal Carcinoma","Breast Cancer With Low to Intermediate HER2 Expression","Breast Cancer (Early Breast Cancer)","Breast Cancer - Female",[285,636,637,638],"Detection","Liquid biopsy","miRNAs","2026-01-13",{"date":641,"type":44},"2026-01-15",{"date":643,"type":44},"2025-10-17",{"date":645,"type":22},"2026-02-28",{"name":647,"class":265},"Oncoliq US Inc",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":18,"minAge":656,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":23,"phases":659,"briefSummary":660,"conditions":661,"keywords":662,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":665,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":672},"100550335","post-operative-radiotherapy-omission-in-selected-patients-with-early-breast-cancer-trial-international-version-prospective-100550335","NCT06445738","Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)","A Two-arm, Non-randomised, Prospective, Multicentre Study Using Magnetic Resonance Imaging (MRI) Findings and Pathology Features to Select Patients With Early Breast Cancer for Omission of Post-operative Radiotherapy","PROSPECTIVE","Inclusion Criteria:\n\nFor inclusion in the study at Registration, participants must fulfil all of the following criteria:\n\n1. Has provided written, informed consent to participate in the study.\n2. Female participants ≥ 50 years old with histologically\\* confirmed ER-positive and\u002For HER2-positive invasive breast cancer.\n3. Has a life expectancy of at least 10 years and suitable for prolonged follow up for 10 years.\n4. Breast imaging indicating unifocal, unilateral breast cancer must have been performed before pre-registration.\n5. Willing\u002Fable to have surgery within 8 weeks of registration or pre-operative MRI, whichever occurs later.\n6. Have ECOG performance status 0-2.\n\n   * Oestrogen receptor and progesterone receptor status of invasive cancer will be assessed by immunohistochemistry on the diagnostic core biopsy specimen. The IHC results will be reported as percentage of nuclei stained and a score of intensity from negative, weak, intermediate or high staining\n\nHER2 neu status will be assessed by immunohistochemistry and will be scored as follows46:\n\n* 0 or 1+ (HER2 negative): No staining or membrane staining that is incomplete and is faint\u002Fbarely perceptible and in ≤ 10% of tumour cells (0); or incomplete membrane staining that is faint\u002Fbarely perceptible and in \\> 10% of tumour cells (1+).\n* 2+ (equivocal): weak to moderate complete membrane staining observed in \\> 10% of tumour cells. Must order reflex test (same specimen using ISH) or order a new test (new specimen if available using HIS or ISH).\n* 3+ (HER2 positive): Circumferential membrane staining that is complete, intense and in \\> 10% of tumour cells.\n\nExclusion Criteria:\n\nAny one of the following at Registration is regarded as a criterion for exclusion from the study:\n\n1. Triple negative breast cancer (ER-negative and PR-negative and HER2-negative) where ER and PR positivity is defined as ≥ 10% staining on IHC.\n2. Previous invasive breast cancer and\u002For DCIS in either breast.\n3. Prior RT to the breast or chest.\n4. Participants who plan to have a mastectomy for the index cancer.\n5. Lymphovascular invasion (LVI) reported on diagnostic core biopsy.\n6. Multifocal\u002Fmulticentric breast cancer on breast imaging before registration.\n7. Distant metastasis at diagnosis.\n8. Bilateral breast cancer\n9. Known breast cancer predisposition gene mutation carriers (BRCA1, BRCA2, PALB2, CHEK2, ATM, CDK1, p53, BARD1, RAD51C, RAD51D, CDH1, STK11, PTEN).\n10. Contraindication to breast MRI scanning.\n11. Concurrent illness\u002Fconditions which limits life expectancy to 10 years or less.\n12. Has moderate or marked BPE in the breast containing the index cancer (where MRI is done before registration).\n13. Inability to give informed consent.\n\nAllocation: Arm A - Radiotherapy Omission\n\nIn addition to the above criteria, for inclusion in the omission of radiation therapy arm of the study after surgery, participants must fulfil all the following criteria. Participants not fulfilling any one of the following criterial will be allocated to Arm B:\n\n1. Has nil\u002Fminimal or mild BPE in the breast containing the index lesion on pre-operative breast MRI.\n2. BCS with unifocal\\*\\*, invasive primary tumour (including any surrounding DCIS) ≤ 20 mm.\n\n   The overall tumour size (including additional foci of DCIS) must remain ≤ 20 mm. The tumour size is defined as the longest distance between the outer most edges of all foci, the space between the two or more foci is included in the overall size: Size = ('Focus A + Focus B + 'the distance between A and B').\n3. Radial resection margins must be ≥ 2 mm clear of any invasive cancer and ≥ 2 mm clear of any DCIS. Superficial or deep margins of \\\u003C 2 mm for invasive cancer and DCIS are allowed if there is no tumour on ink and all breast tissue from the subcutaneous tissue or pectoralis fascia respectively was removed and radial margins are ≥ 2 mm for invasive cancer and DCIS.\n4. pN0 (pN0 i+ is eligible for inclusion) by sentinel node biopsy and\u002For axillary dissection.\n5. Absence of LVI and extensive intraductal component (EIC) on final pathology.\n6. The extent of invasive cancer is at least 50% of the total tumour size (invasive cancer + DCIS).\n7. Have no additional BIRADS 3+ lesions not shown to be benign on pre-operative or surgical biopsy.\n8. Participants with Grade 3 cancer and\u002For HER2-positive cancer must agree to comply with systemic treatment recommendations.\n9. Participants must be allocated to a treatment arm within 8 weeks after final breast surgery.\n\n   * Where histopathology is unable to identify a 'bridge' of tumour tissue joining two or more apparent invasive cancer foci the following will be used to confirm unifocal disease:\n\n     * All foci must be of the same histological subtype\n     * All foci must have the same hormone (ER and PR) and HER2 status.\n\nAllocation: Arm B - Standard Treatment (ineligible for RT omission on study; includes management of MRI-detected lesions)\n\nIn addition to the above Inclusion Criteria, participants who fulfil one any of the following criteria will receive standard treatment:\n\n1. Has moderate or marked BPE in the breast containing the index lesion on pre-operative breast MRI.\n2. Has a biopsy-proven mOL identified on breast MRI.\n3. Suspicious lesion identified on CEM but not on MRI and confirmed on investigation to be a DCIS or invasive breast cancer.\n4. Surgical pathology does not meet the inclusion criteria. 2mm radial margins are required, as guidelines suggesting \"no tumour on ink\" relate to those receiving adjuvant RT.\n5. Clinical team meeting determination that RT be recommended.\n6. Participant chooses to have RT despite being eligible for RT omission.","50 Years",{"count":658,"type":22},1400,[65],"The PROSPECTIVE trial aims to find out if using the results of Magnetic Resonance Imaging (MRI) for early breast cancer can select people to not have radiotherapy and still have a low chance of the cancer coming back after surgery.\n\nThe main question it aims to answer is:\n\n\\* Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer, but who don't have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy.",[127,28],[663,664],"Omission of radiotherapy","Magnetic Resonance Imaging (MRI)",{"date":641,"type":44},{"date":667,"type":44},"2025-06-06",{"date":669,"type":22},"2039-06",{"name":671,"class":51},"Breast Cancer Trials, Australia and New Zealand",9,{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":677,"acronym":4,"eligibilityCriteria":678,"healthyVolunteers":273,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":23,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":4},"100519593","vascular-supply-identification-lesion-extension-and-search-for-tumor-similarity-at-a-distance-by-vtm-in-breast-cancer-100519593","NCT06045572","Vascular Supply Identification, Lesion Extension and Search for Tumor Similarity at a Distance by VTM in Breast Cancer","Inclusion Criteria:\n\nWomen ≥18 years old; Women with breast cancer before oncological treatment; Voluntary signature of the Free and Informed Consent Term.\n\nExclusion Criteria:\n\nPregnant or lactating women; Patients already included in other clinical trials; Patients who are undergoing radiotherapy, chemotherapy or post-cancer surgery treatment; Patients who need urgent or emergency care; Patients with fever or other illness that affects the integrity of the skin; Any clinically significant medical condition or medical history that, in the opinion of the investigator, may discourage participation in the study.",{"count":251,"type":22},[65],"When we talk about early identification, we are talking about an ALREADY EXISTING INJURY, triggering a change in the patient's quality of life and a projection of future costs for the health system.\n\nINNOVATIVE ASPECT: While screening mammography identifies an existing lesion, VTM could: Make an early diagnosis before the formation of a visible or palpable tumor mass; Check the metabolic activity in suspicious lesions identified by other diagnostic methods; Demarcate tumor range and tumor similarity from a distance in breast cancer.\n\nRegarding the Risk x Benefit:There are no medications incorporated, associated or administered by the equipment; There is no ionizing radiation incorporated or delivered by the equipment; There are no contraindications for the use of the equipment by the patient (Non-ionizing infrared radiation, without contrast or contact); Audience destined to operate the equipment: Physician \u002F Radiologist with training Therefore, the research in question is of great relevance for such a debilitating health problem for the patient and for the health system.",[28],"2026-01-09",{"date":685,"type":44},"2026-01-12",{"date":687,"type":22},"2026-06-01",{"date":689,"type":22},"2027-06-01",{"name":691,"class":51},"Galzu Institute of Research, Teaching, Science and Applied Technology"]