[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundacio Clinic Barcelona\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100550423","diagnostic-her2dx-guided-treatment-for-patients-with-early-stage-her2-positive-breast-cancer-100550423",false,"NCT06446882","Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer","Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer","DEFINITIVE","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to any trial-specific procedure. Note: Candidate patients in France must be affiliated to a Social Security System (or equivalent).\n2. Male\u002Ffemale patients who are at least 18 years of age on the day of signing informed consent.\n3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n4. Eligible for any of the following drugs: taxane, carboplatin, trastuzumab, pertuzumab and T-DM1 therapy.\n5. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed.\n6. Stage at presentation: cT1 cN1-2 or cT2-3 cN0-2 as determined by AJCC staging system, 8th edition (specifically in accordance with Anatomic Stage group rules).\n\n   Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy. This procedure at screening will be omitted if there is no suspicion for positive axillary lymph node(s) radiographically or if a pathological report of suspicious lymph nodes of the results of a fine needle biopsy or core biopsy is available prior to the screening period.\n7. Absence of distant metastasis (i.e., cM0).\n8. Patients with multifocal tumors (more than one mass confined to the same quadrant as primary tumor) are eligible provided at least one focus is sampled and locally confirmed as HER2-positive.\n9. Patients with multicentric tumors (multiple tumors involving more than one quadrant) are eligible provided all discrete lesions are sampled and locally confirmed as HER2-positive.\n\n   Note: In patients with multifocal or multicentric breast cancer, the largest lesion should be measured to determine T stage and to performe the HER2DX test.\n10. HER2 positivity defined as either of the following: IHC 3+ or HER2 2+\u002F ISH positive as per most recent ASCO- CAP guideline according to the local laboratory as determined on the most recently analyzed tissue sample.\n11. ER\u002FPR status determined local based on pretreatment breast biopsy material according to the most recent ASCO\u002FCAP guidelines.\n12. Candidates for neoadjuvant treatment.\n13. Patient agreement to undergo appropriate surgical management, including axillary lymph node surgery and partial or total mastectomy, after completion of neoadjuvant treatment\n14. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.\n15. Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor in the breast for diagnostic HER2DX test. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Archival tumor tissue or ex professo biopsy are acceptable.\n16. Adequate hematologic and end-organ function.\n17. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n\n    * Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period, 6 months after the final dose of doxorubicin, 12 months after the final dose of cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last. Women must refrain from donating eggs during this same period.\n    * A woman is of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\> 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n    * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, copper intrauterine devices, hormonal contraceptives that inhibit ovulation, and hormone-releasing intrauterine devices in women with hormone receptor-negative tumors only; the use of hormonal contraceptives and hormone releasing intrauterine devices are prohibited in women with hormone receptor-positive tumors.\n    * The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n18. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n    * With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 6 months after the final dose of doxorubicin and\u002For cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last. Men must refrain from donating sperm during this same period. Male patients are encouraged to seek advice regarding cryoconservation of sperm prior to commencing study treatment because of the possibility of infertility with CT.\n    * With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of doxorubicin and\u002For cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last to avoid exposing the embryo.\n    * The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer.\n2. Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, carboplatin, T-DM1, docetaxel or paclitaxel.\n3. Patients with synchronous bilateral invasive breast cancer.\n4. Prior systemic therapy for treatment of breast cancer.\n5. Ulcerating or inflammatory breast cancer.\n6. Undergone incisional and\u002For excisional biopsy of primary tumor and\u002For axillary lymph nodes.\n7. Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy.\n8. Patients with a history of previous breast cancer are excluded. Patients with a history of any other cancers (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years are excluded. For patients with a history of other non-breast cancerscancerscancers within 3 years and considered of low risk of recurrence per investigator's judgment (for example, papillary thyroid cancer treated with surgery), eligibility is to be discussed with the Sponsor.\n9. Cardiopulmonary dysfunction as defined by any of the following prior to randomization:\n\n   * History of congestive heart failure of any classification.\n   * Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease.\n   * High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate \\> 100\u002Fmin at rest, significant ventricular arrhythmia \\[ventricular tachycardia\\], or higher-grade atrioventricular \\[AV\\]-block \\[second degree AV-block Type 2 \\[Mobitz 2\\] or third-degree AV-block\\]).\n   * Significant symptoms (Grade \\> 1) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia.\n   * Myocardial infarction within 12 months prior to randomization.\n   * Evidence of transmural infarction on ECG.\n   * Requirement for oxygen therapy.\n   * Dyspnea at rest.\n10. Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the Study.\n11. Severe infection within 4 weeks prior to initiation of Study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n12. History of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the Study, the evaluation of response, or with consent procedure.\n13. Pregnancy or breastfeeding, or intention of becoming pregnant during Study treatment or within 6 months after the final dose of paclitaxel, or 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last.\n\n    Note: Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of Study treatment.\n14. Persons deprived of their liberty or under protective custody or guardianship.\n15. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.","ALL","18 Years",{"count":20,"type":21},304,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary goal of the DEFINITIVE trial is to demonstrate the effectiveness of the HER2DX diagnostic assay in enhancing the management of patients with early-stage HER2- positive breast cancer.\n\nPatients randomized to arm A will receive adjuvant treatment by physician´s choice, blinded to the diagnostic HER2DX test results. Patients randomized to Arm B will receive personalized treatment according to HER2DX results.",[27,28],"HER2-positive Breast Cancer","Early-stage Breast Cancer","RECRUITING","2026-02-19",{"date":32,"type":33},"2026-02-20","ACTUAL",{"date":35,"type":33},"2024-10-11",{"date":37,"type":21},"2028-11",{"name":39,"class":40},"Fundacio Clinic Barcelona","OTHER",29,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100473968","phase-1-treatment-of-advanced-or-metastatic-triple-negative-breast-cancer-with-adoptive-therapy-of-pd1-tils-100473968","NCT05451784","Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS","Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ Tumor-infiltrating Lymphocytes (TILS001 Trial)","TILS001","Eligibility criteria for Part #1 (Molecular pre-screening: Determination of PD1 by mRNA analysis from an archival FFPE tumor sample):\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Age ≥ 18 years.\n2. Estimated life expectancy of ≥6 months.\n3. Histologically confirmed diagnosis of unresectable or metastatic breast cancer.\n4. Histologically confirmed diagnosis of advanced triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria: HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+, and ER and PgR expressions \\\u003C10% as determined locally by IHC assay as per most recent ASCO\u002FCAP guidelines.\n5. Patients could have received a maximum of 5 lines of prior standard of care chemotherapy in the inoperable\u002Fmetastatic setting.\n6. Patients must not have history of other malignancy within the past 3 years with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease at the time of enrollment; adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment; adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment; prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment; adequately treated superficial or in-situ carcinoma of the bladder without evidence of disease at the time of enrollment.\n7. Subject likely to be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the subject and investigator's knowledge.\n8. Absence of psychiatric or physiologic history, substance abuse, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n9. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n10. Pregnant or breastfeeding women will NOT be eligible.\n11. Subject has known sensitivity to any of the products or components to be administered during dosing will NOT be eligible.\n12. NOT having an immediate family member (eg, spouse, parent\u002Flegal guardian, sibling, or child) who is investigational site or sponsor staff directly involved in this trial, unless prospective institutional review board (IRB)\u002Findependent ethics committee (IEC) approval (by chair or designee) is given allowing an exception to this criterion for a specific subject\n13. Patients must NOT have undergone prior allogeneic hematopoietic stem cell transplantation\n14. Patients with a history or evidence of symptomatic autoimmune will NOT be eligible: glomerulonephritis, vasculitis, or other symptomatic autoimmune diseases, or active autoimmune disease or syndrome that has required systemic treatment in the past 2 years (ie, with the use of disease-modifying agents, corticosteroids or immunosuppressive drugs) except vitiligo or resolved childhood asthma\u002Fatopy. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n15. Absence of active bacillus tuberculosis history.\n16. Absence of a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.\n17. Absence of a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required.\n18. To be able to provide either a newly obtained tumor biopsy (preferred) or archival tumor tissue of an FFPE tumor block. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for gene expression analysis prior to enrollment in Part #2.\n\nEligibility criteria for Part #2 (Pre-Screening Phase: Selection, isolation and partial expansion of PD1+ TILs from a fresh tumor sample):\n\nParticipants are eligible to be included in the study only if all the previous and the following criteria apply:\n\n1. Patients will be eligible for Part #2 if they have a PD-1 mRNA expression above the 20th percentile in the FFPE tumor sample analyzed in Part 1.\n2. At least 1 resectable target lesion\n3. Patients must NOT have clinically active cerebral metastases. Carcinomatous meningitis is not allowed regardless of clinical stability.\n\nEligibility criteria for Part #3 (Screening and treatment Phase: Complete expansion of PD1+TILs. Treatment of patients with PD1+ TILs infusion):\n\nParticipants are eligible to be included in the study only if all of the previous and the following criteria apply. For being included in this section, the following criteria must apply:\n\n1. PD1+ TILs selection in Part #1 and successful partial expansion of tumor sample in Part #2\n2. Treatment-related toxicities (except alopecia and neuropathy G2) must ≤ Grade 1 at the time of allocation according to CTCAE version 5.0.\n3. All patients must have received two or more prior systemic therapies, including at least one of them for advanced disease and an ADC. A maximum of five chemotherapy-based lines are permitted in the metastatic setting. Prior treatment should be discontinued 28 days or 5 half-lives, whichever is shorter, before day 1 of NMA-LD.\n4. Measurable disease according to RECIST 1.1 criteria.\n5. Adequate organ function determined within 28 days prior to enrollment.\n6. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to enrollment.\n7. For patients ≥ 60 years or patients who have a history of ischemic heart disease, chest pain, or clinically significant atrial and\u002For ventricular arrhythmias, a cardiac stress tests must be performed showing normal LVEF, NYHA functional classification \\\u003C class 1 and if any wall movement abnormalities, they must be reversible.\n8. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO or MUGA\n9. Patients must not be currently receiving treatment with another investigational device or drug study. No other investigational procedures (of any kind) are permitted while participating in this study.\n10. Systemic steroid therapy is not permitted (patients who require replacement therapy for adrenal insufficiency may be enrolled if the steroid treatment dose does not exceed 10 mg of prednisone or equivalent).\n11. Patients with evidence of clinically significant immunosuppression will NOT be eligible.\n12. Patients with evidence of (non-infectious) pneumonitis that required steroids or current pneumonitis will NOT be eligible.",{"count":51,"type":21},20,[53,54],"PHASE1","PHASE2","This is a prospective, multicenter, phase I\u002FII, open-label, two-stage design of PD1+ TILs infusion in metastatic or advanced TNBC. TILS001 includes 3 parts. Previous to each phase inclusion, a specific ICF must be signed by the patient. Participants potentially eligible to participate in the clinical trial will be offered to sign a ICF three times prior to TILs treatment: 1) to allow for collection of archival FFPE tissue samples for determination PD1 by mRNA (Part #1), 2) prior to a fresh metastatic biopsy for selection, isolation and partial expansion of PD1+ TILs (Part #2) and 3) prior to allow for remaining study procedures and TILs therapy (Part #3, Main Consent).",[57],"Metastatic Triple-Negative Breast Carcinoma",[59,60,61,62],"TNBC","Breast Cancer","metastatic","triple negative","2023-11-21",{"date":65,"type":33},"2023-11-24",{"date":67,"type":33},"2022-07-20",{"date":69,"type":21},"2027-09-30",{"name":39,"class":40},4,""]