[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-recurrent":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,74,108,130,155,178,200],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100484813","partial-breast-re-irradiation-using-ultra-hypofractionation-preserve-100484813",false,"NCT05592938","Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)","Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)","PRESERVE","Inclusion Criteria:\n\n* Age \\> 18 years\n* In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)\n* Tumour \\\u003C3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components\n* \\>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)\n* Clinically node negative\n* Negative margins (no tumour on ink)\n* Recovered from surgery with the incision completely healed and no signs of infection\n\nExclusion Criteria:\n\n* Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)\n* Tumour histology limited to lobular carcinoma only\n* Extensive intraductal component\n* T4 disease\n* Node positive or distant metastatic disease\n* Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment\n* Currently pregnant or lactating\n* Presence of an ipsilateral breast implant or pacemaker\n* Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy\n* Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).\n* Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol\n* Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0","FEMALE","18 Years","99 Years",{"count":21,"type":22},171,"ESTIMATED","INTERVENTIONAL",[25],"NA","Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\\\u003C13% grade \\>3 toxicity).",[28,29],"Breast Cancer","Breast Cancer Recurrent",[31],"Hypofractionated","RECRUITING","2026-05-22",{"date":35,"type":36},"2026-05-28","ACTUAL",{"date":38,"type":36},"2023-06-27",{"date":40,"type":22},"2027-06-27",{"name":42,"class":43},"University Health Network, Toronto","OTHER",19,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100639217","phase-1-apbi-re-irradiation-100639217","NCT07612254","aPBI Re-irradiation","REPEAT: RE-irradiation With a Partial brEast, Accelerated Technique: A Single-Center, Multi-site, Prospective, Phase I\u002FII Clinical Trial","REPEAT","Inclusion Criteria\n\n1. Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy.\n2. Patients must have received prior radiotherapy to the breast\n3. Patients must have an intact, involved breast.\n4. Patients must meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation.\n\n   * Grade 1-2 disease\n   * ER-positive histology\n   * Tumor size up to 2 cm\n   * Patient's age 40 or older\n5. Patients who will undergo breast radiation therapy at D-H Lebanon, D-H St. Johnsbury, or Cheshire Medical Center.\n6. Patients must have a lumpectomy cavity that can be delineated on CT scan.\n7. Patients who are able to provide informed consent.\n8. Females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.\n9. Females of childbearing potential must not be pregnant and not lactating and willing to use medically acceptable form of contraception during radiation therapy.\n\nExclusion Criteria\n\nPatients who meet any of the criteria below may NOT participate in this study:\n\n1. Patients who have not received prior radiotherapy to the ipsilateral breast.\n2. Patients who do not meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation, including those who meet criteria for conditionally recommended, conditionally not recommended, and not recommended for partial breast irradiation.\n3. Patients who are \\\u003C 40 years of age.\n4. Patients with breast implants or other breast reconstruction.\n5. Patients who received a prior course of aPBI or breast brachytherapy in the ipsilateral breast.\n6. Patients who are actively receiving treatment or within 1 year of treatment from another malignancy, excluding non-melanoma skin cancers.\n7. Patients who are pregnant.\n8. Patients who are unable to provide informed consent.\n9. Patients who decline participation in the study.\n10. Patients with active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash are excluded.","ALL","40 Years",{"count":56,"type":22},30,[58,59],"PHASE1","PHASE2","This study is to determine whether acute treatment-associated adverse events following breast re-irradiation with aPBI are acceptably low and to assess local control following breast re-irradiation with aPBI. An exploratory aim is to assess cosmetic outcomes following breast re-irradiation with aPBI.",[29],[63],"Ipsilateral","NOT_YET_RECRUITING","2026-05-20",{"date":35,"type":36},{"date":68,"type":22},"2026-06-03",{"date":70,"type":22},"2033-04",{"name":72,"class":43},"Dartmouth-Hitchcock Medical Center",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100577497","phase-1-first-in-human-study-of-atx-295-an-oral-inhibitor-of-kif18a-in-patients-with-advanced-or-metastatic-solid-tumors-including-ovarian-cancer-100577497","NCT06799065","First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer","Key Inclusion Criteria:\n\n* Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC\n* Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant\n* There is no limit to the number of prior treatment regimens\n* Have measurable or evaluable disease\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nKey Exclusion Criteria:\n\n* Clinically unstable central nervous system (CNS) tumors or brain metastasis\n* Any other concurrent anti-cancer treatment, except for hormonal blockade\n* Has undergone a major surgery within 3 weeks of starting study treatment\n* Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial\n* Clinically significant (ie, active) or uncontrolled cardiovascular disease\n* Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.\n* Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers\n* Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment\n\nOther inclusion and exclusion criteria as defined in the study protocol",{"count":82,"type":22},90,[58],"The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-295 in patients with advanced solid tumors and ovarian cancer.",[86,29,87,88,89],"Advanced Solid Tumors","Ovarian Cancer","High-grade Serous Ovarian Carcinoma","Triple Negative Breast Cancer",[91,92,93,94,95,96],"KIF","KIF18A","HGSOC","Platinum-resistant","Platinum-intolerant","Platinum-refractory","2026-02-21",{"date":99,"type":36},"2026-02-24",{"date":101,"type":36},"2025-03-21",{"date":103,"type":22},"2027-08-30",{"name":105,"class":106},"Accent Therapeutics","INDUSTRY",5,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":73},"100474913","phase-2-functional-precision-oncology-to-predict-prevent-and-treat-early-metastatic-recurrence-of-tnbc-100474913","NCT05464082","Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of TNBC","Towards Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of Triple Negative Breast Cancer","TOWARDS-II","Registration: Pre-tumor Collection Eligibility Participant Inclusion Criteria\n\n* Subject aged ≥ 18 years.\n* Subject has Stage I-III disease.\n* Histologically or cytologically confirmed invasive breast carcinoma that is triple negative (TNBC) or hormone receptor (HR)-low\u002FHer2 negative\n\n  --TNBC is defined as:\n  * HER2 expression 0 or 1+ on immunohistochemistry (IHC) or non-amplified (defined as HER2\u002FCEP17 ratio \\\u003C2 or copy number \\\u003C6) on fluorescence in situ hybridization (FISH). If HER2 expression is 2+ on IHC, non-amplified HER2 expression must be confirmed by FISH. Pathologic diagnosis of TNBC (negative HER2 status by cytogenetics, \\\u003C1% of cells stained positive for estrogen receptor (ER) by IHC, and \\\u003C1% of cells stained positive for progesterone receptor (PR) by IHC).\n\n    --HR-low\u002FHer2(-) is defined as:\n  * HER2 expression 0 or 1+ on IHC or non-amplified (defined as HER2\u002FCEP17 ratio \\\u003C2 or copy number \\\u003C6) on fluorescence in situ hybridization (FISH). If HER2 expression is 2+ on IHC, non-amplified HER2 expression must be confirmed by FISH.1-10% of cells stained positive for ER by IHC, and\u002For 1-10% of cells stained positive for PR by IHC).\n* Primary tumor OR local lymph node metastasis that is ≥ 1.5 cm. Patients with inflammatory breast cancer are eligible, regardless of tumor size. Patients with multifocal or multicentric breast cancer are eligible so long as ALL tumors biopsied per standard of care guidelines and\u002For investigator discretion meet receptor status criteria, and at least one tumor measures ≥ 1.5 cm.\n* Patient is considered for preoperative cytotoxic chemotherapy per standard of care or in the context of a separate, ongoing clinical trial.\n* Patient has not received any prior therapy for thier breast cancer.\n* Willing and capable (per treating investigator's assessment) to undergo baseline tumor material collection from the primary tumor or lymph node metastasis.\n* Patient can safely undergo tumor collection:\n\n  * The tumor is reasonably accessible to tumor collection\n  * The tumor is amenable to tumor collection (e.g. does not abut neurovascular structures)\n  * If the patient receives anticoagulation, anticoagulation can be safely withheld to accommodate for tumor material acquisition\n  * The patient does not have a medical condition that would render tumor acquisition a high-risk procedure (e.g. tumor material acquisition from lung metastases in a patient with emphysema)\n* Life expectancy of ≥ 12 months as assessed by the treating investigator.\n* ECOG Performance Status ≤ 2.\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have estradiol and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* No prior history of local or locally advanced hormone receptor positive (ER and\u002For PR expression \\>10% on immunohistochemistry) breast cancer, unless the following conditions are met:\n\n  * All treatment with curative intent has been completed, except adjuvant medical non-chemotherapy treatments (e.g. adjuvant endocrine therapy with any hormonal agent and\u002For CDK4\u002F6 inhibitors), AND\n  * An interval of ≥6 months has elapsed between completion of these treatments and histologic diagnosis of eligible breast cancer.\n\nPhysician Inclusion Criteria\n\n* Physician is the treating medical oncologist for a patient who meets all of the inclusion criteria and none of the exclusion criteria. If care has been transferred to a new physician while the patient is on-study, physician is the treating medical oncologist for the patient who met all of the inclusion criteria and none of the exclusion criteria at the time of patient study enrollment.\n* Willing and able to answer the physician questionnaires at the protocol required time points.\n* Willing and able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nParticipant Exclusion Criteria\n\n* Evidence of metastatic breast cancer\n* ER and\u002For PR expression \\>10% on immunohistochemistry\n* Her2(+) and\u002For Her2-amplified breast cancer. HER2 expression 3+ on IHC or amplified (defined as HER2\u002FCEP17 ratio ≥2 or copy number \\>6) on fluorescence in situ hybridization (FISH). If HER2 expression is 2+ on IHC, reflex FISH must be performed to determine eligibility.\n* Patient has bilateral breast cancer\n* Patient received any anti-cancer therapy or any investigational therapy prior to study entry and collection of tumor.\n\n  --Treatment includes: neoadjuvant therapy, radiation therapy, chemotherapy, bisphosphonates for an indication other than osteopenia\u002Fosteoporosis, and\u002For hormonal therapy administered for the currently diagnosed primary breast cancer prior to study entry. Hormonal therapy for a prior diagnosis of a hormone receptor-positive breast cancer us allowed.\n* The diagnosis of another malignancy, unless the patient is considered disease-free for ≥5 years before study entry. Patients are eligible if diagnosed and treated for carcinoma in situ of the cervix, melanoma in situ, colon cancer in situ, ductal carcinoma in situ, and basal and\u002For squamous cell carcinoma of the skin, early stage papillary thyroid cancer, and other low risk malignancies per investigator discretion.\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (\\> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication.\n  * Renal or liver disease that prohibits the patient from receiving at least single-agent full recommended dose chemotherapy.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 500 ms.\n    * Known congenital long QT.\n    * Left ventricular ejection fraction \\\u003C 55%.\n    * Uncontrolled hypertension defined as ≥ 160\u002F100 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.\n  * Any other 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 (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\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.",{"count":117,"type":22},80,[59],"This is a prospective phase 2 study to use Functional Precision Oncology (FPO) to predict, prevent and treat early metastatic recurrence in subjects with HR-low\u002FHer2 negative or triple negative breast cancer.",[29],"2026-02-18",{"date":123,"type":36},"2026-02-20",{"date":125,"type":36},"2023-01-06",{"date":127,"type":22},"2028-09-30",{"name":129,"class":43},"University of Utah",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100566743","thermotherapy-in-addition-to-soc-palliative-radiotherapy-100566743","NCT06659146","Thermotherapy in Addition to SOC Palliative Radiotherapy","Prospective Study to Assess the Real-world Implementation of Thermotherapy Using wIRA (Water-filtered Infrared A Superficial Hyperthermia) in Addition to Standard of Care (SOC) Palliative Radiotherapy (RT)","ThermoRad wIRA","Inclusion Criteria:\n\n1. Patient with histologically confirmed incurable or inoperable cancers with disease \\[at least one superficial lesion(s) or lymph node(s)\\] suitable for hydrosun® TWH1500 treatment\n2. Patient undergoing standard of care palliative radiotherapy (suitable with the pre-specified dose and fractionation in the protocol\n3. Aged ≥18 years old\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n5. Patient with capacity to consent\n\nExclusion Criteria:\n\n1. No superficial tumour lesion or lymph node that is suitable for hydrosun® TWH1500 treatment.\n2. Patients are not suitable for one of the pre-specified palliative radiotherapy dose and fractionation\n3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.",{"count":139,"type":22},60,[25],"This study aims to investigate the efficacy and safety profile of superficial hyperthermia (wIRA) in addition to standard of care (SOC) palliative radiotherapy in patients with inoperable\u002Fincurable locally advanced or recurrent\u002Fmetastatic HNSCC or cutaneous SCC superficial tumours not suitable for radical treatment.\n\nThe investigators will assess the best objective response rate (ORR) of patients with Inoperable\u002Fincurable or recurrent\u002Fmetastatic HNSCC or cSCC with superficial lesion(s) treated with the combination of superficial hyperthermia (wIRA) and palliative radiotherapy.",[143,144,29],"Head and Neck Squamous Cell Carcinoma","Cutaneous Squamous Cell Carcinoma","2025-12-15",{"date":147,"type":36},"2025-12-22",{"date":149,"type":36},"2024-10-14",{"date":151,"type":22},"2028-03-01",{"name":153,"class":43},"King's College London",2,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":73},"100551309","phase-2-utidelone-capsule-plus-capecitabine-cap-for-metastatic-breast-cancer-100551309","NCT06458413","Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer",":Single-arm, Phase II Clinical Trial of Utidelone Capsule Plus Capecitabine (CAP) in Patients With Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily participate in this study, sign an informed consent form, have good compliance, and are willing to follow-up.\n2. Female, aged ≥ 18 and ≤ 70 years, with an ECOG score of 0-1 and an expected survival time of ≥ 12 weeks.\n3. The pathological and\u002For cytological diagnosis (based on the latest biopsy results) is HER2 negative recurrent or metastatic breast cancer, regardless of hormone receptor status (ER\u002FPR positive or negative, but the hormone receptor status needs to be determined);\n4. All patients have received at least paclitaxel and\u002For anthracycline as a treatment option;\n5. All patients with prior treatment ≤ 3 lines (for those who progress during the neoadjuvant\u002Fadjuvant period or within 12 months after the end of the last treatment, it is considered as the first line, and no progress is counted as the number of lines); For HR+\u002FHER2- breast cancer patients, they also need to have received the first line systemic CDK4\u002F6 inhibitor+endocrine therapy before the disease progresses.\n6. According to RECIST 1.1 standard, there is at least one measurable extracranial lesion present.\n7. Within one week before enrollment, the blood routine examination was basically normal (no blood transfusion within two weeks, no use of drugs to increase white blood cells or platelets):\n\n   Neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 90 × 109\u002FL; Hemoglobin ≥ 9.0 g\u002FdL.\n8. Within one week before enrollment, the blood biochemistry test was basically normal (based on the normal values of each research center laboratory): Total bilirubin (TBIL) ≤ 1.5 x Upper limit of normal value (ULN) SGPT\u002FALT ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); SGOT\u002FAST ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); The creatinine clearance rate (Ccr) is ≥ 50 ml\u002Fmin (Cockcroft Gault formula).\n9. No major organ dysfunction\n10. Women with fertility must agree to use effective contraceptive methods during the study period and within 6 months after the last study medication. Women with fertility must have a negative blood or urine pregnancy test before enrollment.\n\nExclusion Criteria:\n\n1. Other malignant tumors within the 5 years prior to enrollment, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid carcinoma without lymph node metastasis, or squamous cell carcinoma of the skin.\n2. Those who meet the following conditions:\n\n   1. Received systemic anti-tumor therapy within 2 weeks prior to enrollment, including but not limited to endocrine therapy, small molecule targeted therapy, anti-tumor traditional Chinese medicine, etc;\n   2. Within the 4 weeks prior to enrollment, chemotherapy, targeted biological therapy or immunotherapy, other clinical investigational drugs, radiation therapy, or major organ surgery (excluding biopsy) or significant trauma have been received, or elective surgery is required during the trial period. Those who have undergone major surgeries;\n   3. Received nitroso urea or mitomycin C within 6 weeks prior to enrollment;\n3. Individuals who have previously received treatment with Utidelone injection.\n4. Peripheral neuropathy CTCAE 5.0 grade evaluation ≥ 2.\n5. Those who have received treatment with capecitabine or other drugs with an active ingredient of 5-fluorouracil (excluding those who relapse after more than 12 months of treatment).\n6. Pregnant and lactating patients.\n7. Adverse reactions from previous anti-tumor treatments have not yet recovered to CTCAE 5.0 grade ≤1 (excluding toxicity judged by researchers to have no safety risk for hair loss).\n8. Accompanied by meningeal metastasis; Accompanied by uncontrollable brain metastases (researchers have determined that new asymptomatic brain metastases or those known to have stable brain metastases after treatment can be enrolled); Or uncontrollable bone metastasis, which refers to patients who have or have recently been at risk of fractures or have obvious symptoms or other critical situations.\n9. Uncontrollable pleural effusion, pericardial effusion, or abdominal effusion.\n10. Individuals with active infections who currently require systematic anti infection treatment.\n11. Have a history of immunodeficiency, including HIV antibody testing positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.\n12. Individuals with active hepatitis B or hepatitis C; Known active syphilis infection.\n13. Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade II-III atrioventricular block, etc; At rest, the average QTcF obtained from three 12 lead electrocardiogram examinations is\\>470ms; Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular events occurring within 6 months prior to the first administration; Hypertension that cannot be controlled clinically. Other researchers have identified high-risk heart diseases.\n14. Uncontrolled diabetes patients.\n15. Patients with active gastrointestinal ulcers.\n16. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n17. Participate in another clinical trial or use other investigational treatments simultaneously.\n18. Individuals known to be allergic to the investigational drug or any of its excipients.\n19. The researchers believe that the subjects have a history of other serious systemic diseases or other reasons that make them unsuitable to participate in this trial.","70 Years",{"count":164,"type":22},40,[59],"This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients.\n\nThis study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and\u002For anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.",[29],"2024-06-10",{"date":170,"type":36},"2024-06-13",{"date":172,"type":36},"2024-06-05",{"date":174,"type":22},"2025-12-05",{"name":176,"class":177},"Min Yan, MD","OTHER_GOV",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":73},"100495393","18f-fdg-petct-imaging-for-breast-cancer-100495393","NCT05730608","18F-FDG PET\u002FCT Imaging for Breast Cancer","Improving Breast Cancer Staging With 18F-FDG PET\u002FCT Imaging (The IMBRECAS PET Study)","Inclusion Criteria:\n\n* Patients with high risk primary or recurrent breast cancer\n* Non pregnant women \\> 18 years\n* Not receiving active treatment of other cancer types.\n* Eastern Cooperative Oncology Group (ECOG) status 0-2.\n\nExclusion Criteria:\n\n* Pregnant woman\n* Males\n* Age under 18\n* Patients receiving active treatment for other cancers\n* Poor general conditipon (ECOG 3 or higher)",{"count":186,"type":22},300,[25],"Purpose To investigate the ability of 18F-FDG PET\u002FCT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II\u002FIII and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.\n\nHypothesis The hypothesis is that 18F-FDG PET\u002FCT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II\u002FIII or locoregional recurrent BC.\n\nObjectives\n\nPrimary:\n\nTo evaluate if a 18F-FDG PET\u002FCT scan in the initial work up of patients diagnosed with stage II\u002FIII or locoregional recurrent BC will lead to change in staging and\u002For treatment.\n\nSecondary:\n\n* Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET\u002FCT scan compared with the patients with unchanged stage of disease following 18F-FDG PET\u002FCT.\n* Obtain size of the primary BC from CT\u002FMRI scan and evaluate if these metrics are correlated to outcome.\n* Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.\n* Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.\n* Blood and tumor samples for molecular characterisation:",[190,29],"Breast Cancer Female","2024-05-08",{"date":193,"type":36},"2024-05-09",{"date":195,"type":36},"2023-02-16",{"date":197,"type":22},"2032-12-31",{"name":199,"class":43},"Vestre Viken Hospital Trust",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":210,"studyType":211,"phases":4,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100470499","registry-of-local-recurrences-after-breast-conserving-surgery-100470499","NCT05406661","Registry of Local Recurrences After Breast-conserving Surgery","Registry of Local Recurrences After Breast-conserving Surgery in Portugal and Spain","R_ReLoCC","Inclusion Criteria:\n\n1. Female patients\n2. Age \\> 18 years\n3. Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer\n\n   1. and adjuvant breast RT: total (WBI) or partial (PBI)\n   2. without adjuvant radiotherapy to the breast\n4. Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma\n\nExclusion Criteria:\n\n1. Male\n2. Age \\\u003C 18 years\n3. Stage 4 at diagnosis\n4. Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment\n5. History of other primary invasive malignant tumor (except non-melanoma skin carcinomas)\n6. Patients already treated for another local recurrence of breast carcinoma\n7. Absence of clinical follow-up and records in clinical process",{"count":209,"type":22},3000,"5 Years","OBSERVATIONAL","The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain.\n\nThe comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.",[29],[215,216,217],"Breast cancer treatment","Local recurrences","Breast-conserving surgery","2023-10-18",{"date":220,"type":36},"2023-10-19",{"date":222,"type":22},"2023-12-01",{"date":224,"type":22},"2026-12",{"name":226,"class":43},"Universidade do Porto"]