[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-breast-carcinoma":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,70,97,115,150,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100404756","phase-2-measuring-the-effects-of-talazoparib-in-patients-with-advanced-cancer-and-dna-repair-variations-100404756",false,"NCT04550494","Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations","A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response","Inclusion Criteria:\n\n* Adult patients with solid tumors and documented germline or somatic aberrations in genes involved in DNA damage response (DDR) and whose disease has progressed following at least one standard therapy or who have no acceptable standard treatment options. Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable for determination of eligibility\n* Patients with the following germline or somatic genetic aberrations will be eligible based on compelling preclinical and\u002For clinical data suggesting that these deleterious mutations confer sensitivity to PARP inhibitors; no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene will be enrolled\n\n  * Deleterious BRCA1 or BRCA2 mutations\n  * Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN\n  * A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L\n* Age \\>= 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Life expectancy of greater than 3 months\n* Leukocytes \\>= 3,000\u002FmcL\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 10 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (=\\\u003C 3 x upper limit of normal in the presence of documented Gilbert's syndrome or liver metastases at baseline)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional upper limit of normal\n* Creatinine =\\\u003C 1.5 x institutional upper limit of normal OR Creatinine clearance (CrCl) \\>= 60 mL\u002Fmin\u002F1.73m\\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73m\\^2\n* Patients 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\n* Patients must have a tumor site amenable to biopsy. If avoidable, the lesion for biopsy should not be selected as a target lesion for RECIST measurements\n* The effects of talazoparib on the developing human fetus are unknown. For this reason and because PARP inhibitors are known to be teratogenic, women of child-bearing potential must agree to use a highly effective method of contraception for the duration of study participation and for at least 7 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male patients with female partners of reproductive potential and pregnant partners who are treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for at least 4 months after completion of talazoparib administration\n* Patients must be able to swallow whole tablets or capsules. Nasogastric or gastric-tube (G-tube) administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients must have recurrent, locally advanced or metastatic disease\n* Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention, except for those patients without SOC or for whom talazoparib is SOC\n* PATIENTS WITH OVARIAN CANCER:\n* All patients with ovarian cancer should have one prior platinum-based therapy\n* Patients with ovarian cancer with platinum-sensitive disease are eligible. Patients with platinum-refractory disease are not eligible\n* Patients with gBRCAm ovarian cancer must also have progressed on a PARP inhibitor. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH PANCREATIC CANCER:\n* All patients with pancreatic cancer should have received prior platinum-containing therapy in the metastatic setting\n* PATIENTS WITH BREAST CANCER:\n* Patients with HER2+ breast cancer should have had 2 prior systemic lines of therapy in the metastatic setting, including anti-HER2 therapy\n* Patients with breast cancer who are eligible for a PARP inhibitor by Food and Drug Association (FDA) approvals must have had prior PARP inhibitor as per FDA indication. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH GASTRIC CANCER:\n* Patients with HER2+ gastric cancer should have had received anti-HER2 therapy in the metastatic setting\n* PATIENTS WITH PROSTATE CANCER:\n* Patients with prostate cancer who are eligible for a PARP inhibitor by FDA approvals must have had prior PARP inhibitor for eligibility. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* All patients with prostate cancer can continue to receive treatment with gonadotropin-releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on prior therapy\n* Patients with castration resistant prostate cancer must have castrate levels of testosterone (\\\u003C 50 ng\u002FdL \\[1.74 nmol\u002FL\\])\n* Patients with metastatic hormone receptor (HR) prostate cancer and mutations in either BRCA1, BRCA2, or ATM should continue to receive anti-androgen receptor (anti-AR) therapy\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter (6 weeks for nitrosoureas or mitomycin C). Patients must be \\>= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be \\>= 1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events\n* Patients who have had prior treatment with talazoparib are ineligible\n* Patients who have had prior monoclonal antibody therapy must have completed that therapy \\>= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment) except for monoclonal antibody therapies that have been proven to be safe when combined with PARP inhibitor (PARPi) treatment (such as anti-PD-1\u002FPD-L1 and anti-HER2), which must be completed \\>= 4 weeks prior to enrollment\n* Patients who are receiving any other investigational agents\n* Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for \\>= 1 month without requiring steroid and anti-seizure medication are eligible to participate\n* Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib will be determined following review by the principal investigator\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because the effects of the study drugs on the developing fetus are unknown\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded. Low-dose warfarin (=\\\u003C 1 mg\u002Fday) is permitted\n* Women who are currently lactating\n* History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors \"one after the other\" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Castration-Resistant Prostate Carcinoma","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","HER2-Positive Breast Carcinoma","Locally Advanced Breast Carcinoma","Locally Advanced Gastric Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Ovarian Carcinoma","Locally Advanced Pancreatic Carcinoma","Locally Advanced Prostate Carcinoma","Metastatic Breast Carcinoma","Metastatic Gastric Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Ovarian Carcinoma","Metastatic Pancreatic Carcinoma","Metastatic Prostate Carcinoma","Platinum-Sensitive Ovarian Carcinoma","Recurrent Breast Carcinoma","Recurrent Gastric Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Pancreatic Carcinoma","Recurrent Prostate Carcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","RECRUITING","2026-06-18",{"date":60,"type":61},"2026-06-22","ACTUAL",{"date":63,"type":61},"2021-04-26",{"date":65,"type":20},"2026-12-01",{"name":67,"class":68},"National Cancer Institute (NCI)","NIH",4,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100402252","immune-response-to-anti-her2-therapies-in-patients-with-her2-positive-stage-i-iv-breast-cancer-100402252","NCT04517838","Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer","Immune Response to Anti-HER2 Therapies","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histological confirmed adenocarcinoma of the breast stage I-IV from the American Joint Committee on Cancer staging 8th edition\n* Any estrogen receptor (ER) or progesterone receptor (PR) but HER2 positive defined as per the most current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Provide written informed consent\n* Willingness to provide blood samples for correlative research purposes\n* BLOOD AND TISSUE COHORT: Scheduled to start new anti-HER2 therapy\u002Ftherapies\n* TISSUE-ONLY COHORT: Received or previously completed anti-HER2 therapy\u002Ftherapies\n\nExclusion Criteria:\n\n* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive\n* Receiving systemic steroid therapy or any other immunosuppressive therapy =\\\u003C 30 days prior to registration. NOTE: Inhaled steroids, low-dose corticosteroids (e.g. equivalent to or less than oral prednisone 10 mg daily), and steroid use for primary prevention of nausea per institutional guidelines are allowed.","FEMALE",{"count":79,"type":20},230,"OBSERVATIONAL","This study gathers information from the blood cells and tumor tissue during treatment with anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib, in patients with HER2 positive stage I-IV breast cancer who are scheduled to start anti-HER2 therapy. The information gained from this study may help researchers better understand the relation between cell response and anti-HER2 therapies.",[83,31,84,85,26,27],"Breast Adenocarcinoma","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","2026-06-12",{"date":88,"type":61},"2026-06-16",{"date":90,"type":61},"2020-07-31",{"date":92,"type":20},"2028-07-27",{"name":94,"class":95},"Mayo Clinic","OTHER",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":77,"minAge":4,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":114,"locationsCount":96},"100558894","impact-of-aromatase-inhibitor-therapy-on-glucose-homeostasis-and-diabetes-risk-100558894","NCT06557057","Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk","Inclusion Criteria:\n\n* Post-menopausal women with hormone receptor positive breast cancer, ductal carcinoma in situ (DCIS), or with other high risk breast conditions. Post-menopause will be defined as women who experience 12 months of amenorrhea or have undergone bilateral salpingo-oophorectomy.\n\n  * 25 women who are planning to start or are within 6 months of starting treatment with aromatase inhibitors, after consultation in breast clinic and cancer center.\n  * 25 women who will be starting Tamoxifen (comparative group)\n  * 25 healthy post menopausal women will also be recruited.\n\nExclusion Criteria:\n\n* Established diagnosis of diabetes\n* Therapy with medications that could affect glucose metabolism\n* Screening fasting glucose ≥ 126 mg\u002Fdl, and\u002For HbA1c ≥ 6.5%\n* History of upper GI surgery that alters gastric emptying or causing malabsorption e.g., bariatric surgery, fundoplication",true,{"count":105,"type":20},66,"This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.",[31],"2026-03-26",{"date":110,"type":61},"2026-03-31",{"date":112,"type":61},"2023-11-16",{"date":65,"type":20},{"name":94,"class":95},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":77,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100281599","multicenter-trial-for-eliminating-breast-cancer-surgery-or-radiotherapy-in-exceptional-responders-to-neoadjuvant-systemic-therapy-100281599","NCT02945579","Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy","Inclusion Criteria:\n\n* Cohort A1 and A2\n\n  • Conditions for patient eligibility: Patients on this portion of the study can receive radiation treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to, during, or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary nodes on initial ultrasound), clinical stage M0.\n  2. HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER\u002FPR\\< 10% HER2 negative (IHC 1+ or 2+ FISH non-amplified) receiving any standard routine clinical NST regimen.\n  3. Patient desires breast conserving therapy.\n  4. Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences \\[124, 125\\].\n  5. Female sex.\n  6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  7. Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present.\n  8. Patient understands that the breast lesion size on final breast imaging must be less than or equal to 2 cm prior to the biopsy procedure being performed on study and if the biopsy shows residual carcinoma the patient will be taken off study.\n* Cohort B1 and B2\n\n  • Conditions for patient eligibility: Patients on this portion of the study will be limited to receive radiation treatment at MD Anderson Cancer Center or other approved locations and must be enrolled prior to any neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. ER and\u002For PR positive, HER2 negative\n  2. Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion,\n  3. At least 40 years of age.\n  4. Oncotype ≤ 25 if age ≥ 50 years\n  5. Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years.\n  6. Patient agrees to take anti-estrogen therapy and is interested in breast conservation\n  7. Female sex.\n  8. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  9. No history of prior radiation to the area of the breast that would require protocol-mandated treatment\n* Cohort C\n\n  • Conditions for patient eligibility: Patients on this portion of the study can receive surgical treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0, clinical stage M0 and HER2 positive (IHC 3+ and or FISH amplified) receiving any standard routine clinical NST regimen containing her-2 directed therapy OR Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 (≤ 2 cm), N0, clinical stage M0 and triple negative, receiving any standard routine clinical NST regimen.\n  2. For cohort C patients participating in the optional pretreatment biopsy, the patient should be able undergo biopsy or surgery of the primary tumor site of suspected or proven invasive breast cancer and should be planned to receive neoadjuvant systemic therapy.\n  3. Patient desires breast conserving therapy.\n  4. Age 30 years or older if HER2 positive. Age 50 or older if HER2 negative (triple negative).\n  5. Female sex.\n  6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  7. Patient must have an initial nodal ultrasound that does not demonstrate suspicious lymph nodes; any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present.\n  8. Patient must have no evidence of residual invasive tumor or DCIS on pathologic review of the lumpectomy surgical specimen\n  9. Patient must have no evidence of metastatic disease or isolated tumor cells involving the lymph nodes on pathologic review of the lymph node surgical specimen. If treatment effect in the nodes is noted on the pathology report, the investigators would generally discourage enrollment on this protocol.\n  10. Unifocal disease or limited multifocal disease that can be excised in a single lumpectomy specimen\n* Cohort D (MD Anderson Houston patients only)\n\n  * Conditions for patient eligibility: Patients on this portion of the study meet all eligibility requirements for cohort C, but have not enrolled onto the study to omit radiation. Patients in Cohort D can be identified at the time of diagnosis or prior to lumpectomy. They are not required to participate in one of the treatment arms of the study, but can ultimately choose to move to an omission Cohort at a later time point.\n\n3.5.1 Patients with triple negative or her-2 positive tumor who are amenable to breast conserving treatment and have received or are planned for neoadjuvant systemic therapy prior to surgery are eligible for Cohort D.\n\n3.5.2 Eligible patients in cohort D who have undergone optional ARTIDIS biopsies of the primary breast tumor at the time of diagnosis, prior to starting neoadjuvant therapy, or following completion of systemic therapy, at the time of surgery, may later move to Cohort A or C if they meet all eligibility requirements and ultimately desire surgery or radiation omission\n\nExclusion Criteria:\n\n1. Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A1\u002FA2\u002FC; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in Cohort B1\u002FB2.\n2. Clinical or pathologic evidence for distant metastases.\n3. Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast.\n4. Clinical evidence of progression of disease \\>20% in the breast or new evidence of nodal metastases.\n5. Patient is known to be pregnant.\n6. Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required in Cohort A1\u002FA2\u002FB1\u002FB2.","30 Years",{"count":123,"type":20},120,[125],"NA","This clinical trial studies eliminating surgery and\u002For radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surgery. In ER positive\u002FHER2 negative breast cancers, after endocrine therapy and ablative radiotherapy, when image-guided biopsy shows no residual cancer, patients then receive standard endocrine therapy with no surgery. For patients who have HER2 positive and triple negative breast cancers and standard surgery, after systemic therapy, breast radiotherapy is being eliminated when the pathology from surgery shows no residual cancer.",[128,129,130,131,132,133,134,135,136,137,138,139],"Estrogen Receptor Negative","HER2 Positive Breast Carcinoma","HER2\u002FNeu Negative","Invasive Breast Carcinoma","Progesterone Receptor Negative","Stage I Breast Cancer AJCC v7","Stage IA Breast Cancer AJCC v7","Stage IB Breast Cancer AJCC v7","Stage II Breast Cancer AJCC v6 and v7","Stage IIA Breast Cancer AJCC v6 and v7","Stage IIB Breast Cancer AJCC v6 and v7","Triple-Negative Breast Carcinoma","2026-03-05",{"date":142,"type":61},"2026-03-09",{"date":144,"type":61},"2017-01-20",{"date":146,"type":20},"2028-01-31",{"name":148,"class":95},"M.D. Anderson Cancer Center",8,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":159,"studyType":80,"phases":4,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":96},"100570566","ai-based-pcr-assessmentprediction-in-her2-positive-bc-using-petmri-100570566","NCT06708910","AI-based pCR Assessment\u002FPrediction in HER2-Positive BC Using PET\u002FMRI","Multiparametric 18F-FDG PET\u002FMRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence","Inclusion Criteria:\n\n* Female\n* HER2-positive breast carcinoma\n* legally competent female patients aged ≥ 18 years\n* willing and able to attend scheduled examinations\n* written informed consent for study participation\n* decision to receive neoadjuvant systemic therapy \u002F exclusion of distant metastases\n\nExclusion Criteria:\n\n* previous cancer diagnosis within the last five years or second, synchronous malignancy\n* contraindication to MRI examination\n* severe renal insufficiency\n* pregnancy or lactation",{"count":158,"type":20},460,"15 Weeks","Goal of the observational study: Based on PET\u002FMRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients.\n\nThe main question it aims to answer are:\n\nPrimary endpoint:\n\n1\\) Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET\u002FMRI (response assessment)\n\nSecondary endpoint(s):\n\n1. Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET\u002FMRI (response assessment)\n2. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG PET\u002FMRI (response assessment)\n3. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET\u002FMRI (response assessment)\n4. Evaluation of pre-treatment (baseline) 18F-FDG PET\u002FMRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence (prediction)\n5. Evaluation of 18F-FDG PET\u002FMRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence (prediction)\n6. Evaluation of 18F-FDG PET\u002FMRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence (prediction)\n\nThe guideline-recommended staging procedure (S3 Germany) using CT will be replaced by a whole-body 18F-FDG PET\u002FMRI, including dedicated 18F-FDG PET\u002FMRI of the breast. The histopathologic results of tissue samples obtained during routine clinical treatment after successful neoadjuvant systemic therapy will serve as a reference standard.\n\nThe study protocol involves the following examinations for all included patients:\n\n1. Baseline (pre-treatment) examination to substitute for the staging examinations specified in the S3 guideline: Initial whole-body 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast\n2. Thoracic 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast after the first two cycles of systemic therapy\n3. Thoracic 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery",[129],"2025-09-23",{"date":164,"type":61},"2025-09-24",{"date":166,"type":61},"2025-07-18",{"date":168,"type":20},"2031-07",{"name":170,"class":95},"Heinrich-Heine University, Duesseldorf",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":180,"conditions":181,"keywords":197,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":96},"100595293","radiomics-to-predict-her2-status-and-t-dxd-efficacy-in-metastatic-breast-cancer-the-radiospher2-study-100595293","NCT07030569","RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study","RADIOSPHER2","Inclusion Criteria:\n\n* Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.\n\nExclusion Criteria:\n\n* Not available imaging (CT scan and\u002For PET-FdG scan) in the three months before the biopsy or before the last previous treatment interruption;\n* Unknown HER2 status;\n* Node, soft tissue or other visceral as biopsy site.",{"count":179,"type":20},500,"RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.",[182,183,184,185,186,187,188,189,190,191,192,193,129,194,195,196],"Radiomic","Radiomics","Breast Cancer Metastatic","Breast Cancer Stage IV","Breast Carcinoma","Breast Neoplasms","Breast Cancer","Breast Cancer With Bone Metastasis","Breast Cancer With Metastatic Bone Disease","Trastuzumab","HER2","HER2 + Breast Cancer","HER2-positive Breast Cancer","Her2\u002FNeu Positive Advanced Solid Tumors","HER2\u002FNeu-positive Breast Cancer",[183,198,199,200,201],"HER2 expression","Trastuzumab Deruxtecan","Pathomics","HER2 heterogeneity","2025-06-12",{"date":204,"type":61},"2025-06-22",{"date":206,"type":61},"2024-02-01",{"date":208,"type":20},"2027-01-01",{"name":210,"class":95},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano"]