[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604597":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":35,"locations":43,"responsibleParty":75,"collaborators":40,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":40,"enrollmentInfo":87,"targetDuration":40,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":105,"whyStopped":40,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"UNICANCER","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sacituzumab-Govitecan and Trastuzumab-deruxtecan in alternating shema","EXPERIMENTAL","Patients will receive either SG and T-DXd in an upfront alternating schema: two cycles of SG, followed by two cycles of T-DXd, then two cycles of SG, and so on, until RECIST 1.1-defined disease progression, unless there is unacceptable toxicity, withdrawal of consent or end of study.",[13],"Drug: Sacituzumab Govitecan \u002F Trastuzumab Deruxtecan",{"label":15,"type":16,"description":17,"interventionNames":18},"Sacituzumab-Govitecan alone","ACTIVE_COMPARATOR","Patient will receive Sacituzumab-Govitecan 1(monotherapy) until RECIST 1.1-defined disease progression, unless there is unacceptable toxicity, withdrawal of consent or end of study",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sacituzumab Govitecan \u002F Trastuzumab Deruxtecan","Sacituzumab govitecan is administered intravenously at a dose of 10 mg\u002Fkg on Day 1 and Day 8 of each 3-week cycle. In this study, patients receive two cycles of sacituzumab govitecan followed by two cycles of trastuzumab deruxtecan, alternating throughout the study.\n\nTrastuzumab deruxtecan is administered intravenously at a dose of 5.4 mg\u002Fkg on Day 1 of each 3-week cycle. In this study, patients receive two cycles of trastuzumab deruxtecan followed by two cycles of sacituzumab govitecan, alternating throughout the study.\n\nBoth Treatment are continued until disease progression as defined by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or the end of the study.",[15,9],[26,27],"Trodelvy","Enhertu",[29,33],{"name":30,"affiliation":31,"role":32},"Alexandre TASSIN DE NONNEVILLE","Institut Paoli-Calmettes","STUDY_CHAIR",{"name":34,"affiliation":31,"role":32},"François BERTUCCI",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"GERALD BAGOE","CONTACT","+337714415 82",null,"g-bagoe@unicancer.fr",{"name":30,"role":38,"phone":40,"phoneExt":40,"email":40},[44,61],{"facility":45,"status":40,"city":46,"state":40,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"institut Paoli calmette","Marseille","13009","France","FR",{"type":51,"coordinates":52},"Point",[53,54],5.38107,43.29695,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":40,"email":60},"Alexandre Alexandre TASSIN DE NONNEVILLE","+33491223333","denonnevillea@ipc.unicancer.fr",{"facility":62,"status":40,"city":63,"state":40,"zip":64,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Gustave Roussy","Villejuif","94800",{"type":51,"coordinates":66},[67,68],2.35992,48.7939,{"lat":68,"lon":67},[71],{"name":72,"role":38,"phone":73,"phoneExt":40,"email":74},"Chayma BOUSRIH","+33142114370","chayma.bousrih@gustaveroussy.fr",{"type":76,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100604597","phase-2-testing-two-different-drugs-sacituzumab-govitecan-and-trastuzumab-deruxtecan-combinations-prescribed-in-an-alterning-pattern-to-patients-with-metastatic-or-locally-advanced-triple-negative-breast-cancer-100604597",false,"NCT07151586","Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer","A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer","ALTER","Inclusion Criteria:\n\n* Patient must have signed a written informed consent prior to any trial specific procedures. (Note : When the patient is physically unable to give his\u002Fher written consent, a impartial witness of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent)\n* Men or women ≥ 18 years of age\n* Histologically confirmed metastatic or locally advanced and unresectable triple-negative breast cancer, meeting both of the following criteria by local testing:\n\nHER2-low breast cancer, defined as either immunohistochemistry (IHC) 2+ \u002F in situ hybridization (ISH)-negative or IHC 1+ (ISH-negative or untested), on either the primary or any metastatic site\n\nEstrogen receptor (ER) expression \\\u003C10% and progesterone receptor (PR) expression \\\u003C10% (Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours correspond to a triple-negative breast cancer meeting the above criteria)\n\n* Patient eligible to receive sacituzumab-govitecan and T-Dxd according to their indication\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n* Women of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment for women and up to 4 months for men.\n\nA woman is considered to be of childbearing potential if she is not postmenopausal or has not undergone hysterectomy. Postmenopausal is defined as any of the following:\n\nAge ≥ 60 years Age \\\u003C 60 years and ≥ 12 continuous months of amenorrhea with no identified cause other than menopause Surgical sterilization (bilateral oophorectomy)\n\n\\- Adequate organ and bone marrow function within 28 days before enrollment. The most recent results available must be used for all parameters below:\n\nHemoglobin ≥ 9 g\u002FdL. Red blood cell transfusion is not allowed within 1 week prior to screening assessment\n\nAbsolute neutrophil count (ANC) ≥ 1,500\u002Fmm³. Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment\n\nPlatelet count ≥ 100,000\u002Fmm³. Platelet transfusion is not allowed within 1 week prior to registration\n\nTotal bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases, or \\\u003C 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline\n\nAlanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or \\\u003C 5 × ULN in patients with liver metastasis\n\nSerum albumin ≥ 2.5 g\u002FdL\n\nCreatinine clearance (CrCl) ≥ 30 mL\u002Fmin, calculated using the Cockcroft-Gault equation: CrCl (mL\u002Fmin) = \\[(140 - age in years) × weight in kg\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\] (× 0.85 for females)\n\n* Adequate cardiac function, defined as a left ventricular ejection fraction ≥ 55% estimated by echocardiogram or multigated acquisition scintigraphy\n* Women of childbearing potential must have a negative serum or urine pregnancy test done within 7 days before randomization\n* Affiliated to the French Social Security System (or equivalent)\n* Patient willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n* Patient previously treated with any ADC targeting HER2 or TROP2\n* Patient with uncontrolled or significant cardiovascular disease\n* Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline\u002Fscreening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening\n* Any medical history or condition that per protocol or in the opinion of the investigator is incompatible with the study\n* Patients with known allergy or severe hypersensitivity to any of the trial drugs or their excipients\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may cause misleading study interpretation or prevent completion of study procedures and followup examinations\n* Patients with any other disease or illness that requires hospitalisation or is incompatible with the trial treatment are not eligible\n* Patients enrolled in another therapeutic trial within 30 days of inclusion\n* Pregnant or breast-feeding women at the time of randomization or intention to become pregnant during the study and up to 7 months after treatment\n* Person deprived of their liberty or under protective custody or guardianship\n* 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":88,"type":89},260,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer.\n\nThe goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?",[95,96,97],"Triple Negative Breast Neoplasms","Neoplasm Metastasis","HER 2 Low-expressing Breast Cancer",[99,100,101,102,103,104],"Antibody-drug conjugates","HER2-low","Triple Negative Breast Cancer","Locally Advanced Breast Cancer","HER2-negative","Metastatic Breast Cancer","NOT_YET_RECRUITING","2025-08-25",{"date":108,"type":109},"2025-09-03","ACTUAL",{"date":111,"type":89},"2025-10",{"date":113,"type":89},"2029-10",{"name":5,"class":6},2]