[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-hrher2--breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-hrher2--breast-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,77,102,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100054172","phase-1-study-of-eci830-single-agent-or-in-combination-in-patients-with-advanced-hrher2--breast-cancer-and-in-patients-with-other-advanced-solid-tumors-100054172",false,"NCT06726148","Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer and in Patients With Other Advanced Solid Tumors","An Open-label, Multi-center, Phase I\u002FII Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors","Inclusion Criteria:\n\nAge ≥ 18 years old.\n\nPatients with one of the following indications:\n\nPhase I:\n\nHR+\u002FHER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n\nHistologically and\u002For cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n\nPatients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed.\n\nPhase II:\n\nHR+\u002FHER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4\u002F6 inhibitor for unresectable\u002Fmetastatic disease with no more than 2 lines of endocrine therapy.\n\nMeasurable disease as determined by RECIST v1.1.\n\nBC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n\nExclusion Criteria:\n\nPrevious treatment with a CDK2 inhibitor at any time.\n\nPatients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n\nClinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.\n\nPresence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n\nFor the combination treatment:\n\nPatients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nPatients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.\n\nFor patients with BC: Patient is concurrently using hormone replacement therapy.\n\nWOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","100 Years",{"count":20,"type":21},280,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization\u002Frecommended dose for future studies.\n\nPhase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) advanced breast cancer.",[28,29,30],"Advanced HR+\u002FHER2- Breast Cancer","Advanced CCNE1-amplified Solid Tumors","Extensive-stage Small Cell Lung Cancer",[32,33,34,35,36,37],"ECI830","Ribociclib","Fulvestrant","Breast cancer","CCNE1 amplification","Small cell lung cancer","RECRUITING","2026-07-09",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2025-04-03",{"date":46,"type":21},"2028-09-25",{"name":48,"class":49},"Novartis Pharmaceuticals","INDUSTRY",33,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100639848","phase-1-study-of-iev407-as-single-agent-or-in-combination-in-patients-with-advanced-hrher2--breast-cancer-100639848","NCT07604571","Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer","An Open-label, Multi-center, Phase I\u002FIb Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with one of the following indications:\n\n  * Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):\n\nHR+\u002FHER2- aBC with disease progression on or following, or have been intolerant to, at least one line of endocrine-based therapy in combination with a CDK4\u002F6 inhibitor and at least one additional line of systemic therapy in the unresectable\u002Fmetastatic setting and not be a candidate for any available standard therapy, in the investigator's judgement.\n\n\\- Dose expansion of IEV407 in combination with fulvestrant: HR+\u002FHER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4\u002F6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable\u002Fmetastatic setting. Prior cytotoxic chemotherapy and\u002For antibody-drug conjugate therapies in the unresectable\u002Fmetastatic setting are not allowed.\n\nExclusion Criteria:\n\n* Patients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Concurrent use of hormone replacement therapy.\n* Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n* For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":59,"type":21},194,[24],"The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.",[28],[64,65,66,67],"IEV407","HR+\u002FHER2- advanced breast cancer","letrozole","fulvestrant","2026-06-29",{"date":70,"type":42},"2026-06-30",{"date":72,"type":42},"2026-05-28",{"date":74,"type":21},"2032-06-08",{"name":48,"class":49},3,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100615111","phase-1-study-of-gvv858-as-a-single-agent-or-in-combination-with-endocrine-therapy-in-patients-with-hrher2--breast-cancer-and-other-advanced-solid-tumors-100615111","NCT07288359","Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","An Open-label, Multi-center, Phase I\u002FII Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Patients with one of the following histologically or cytologically confirmed advanced cancers:\n\nPhase I (patients with one of the following cancers, from whom no standard therapy is available or appropriate in the judgment of the investigator):\n\n* HR+\u002FHER2- advanced breast cancer (aBC) with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n* Locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n* Metastatic castration-resistant prostate adenocarcinoma, with no documented neuroendocrine component, castrate level of testosterone, and no more than 3 prior lines of systemic therapy for metastatic disease.\n\nPhase II:\n\n* HR+\u002FHER2- aBC with disease progression on or after an endocrine therapy in combination, with a CDK4\u002F6 inhibitor for advanced disease with no more than 2 lines of endocrine therapy and no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease.\n\n  \\- Measurable disease as determined by RECIST v1.1.\n* BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n* metastatic Castration-Resistant Prostate Cancer (mCRPC) only: If no measurable disease is present per PCWG3 modified RECIST, then at least 1 metastatic lesion must be present on bone scan imaging.\n\nExclusion Criteria:\n\n* Patients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including myocardial infarction (MI), coronary artery bypass graft (CABG), long QT syndrome, or risk factors for Torsades de Pointes (TdP).\n* Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n* Patients with symptomatic visceral disease, including visceral crisis.\n* For patients with BC: Patient is concurrently using hormone replacement therapy.\n* Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":85,"type":21},205,[24,25],"Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization\u002Frecommended dose for further clinical evaluation.\n\nPhase II: Further characterize the safety and tolerability of GVV858 in combination with fulvestrant in patients with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) advanced breast cancer.",[28,29,89],"Metastatic Castration-resistant Prostate Cancer",[91,34,92,93,36,94],"GVV858","Letrozole","Breast Cancer","Prostate Cancer",{"date":70,"type":42},{"date":97,"type":42},"2025-12-29",{"date":99,"type":21},"2031-05-09",{"name":48,"class":49},12,{"id":103,"slug":4,"hasResults":11,"nctId":12,"briefTitle":104,"officialTitle":14,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":26,"conditions":108,"keywords":109,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":114,"leadSponsor":115,"locationsCount":50},"100571891","Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\nAge ≥ 18 years old.\n\nPatients with one of the following indications:\n\nPhase I:\n\nHR+\u002FHER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n\nHistologically and\u002For cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n\nPhase II:\n\nHR+\u002FHER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4\u002F6 inhibitor for unresectable\u002Fmetastatic disease with no more than 2 lines of endocrine therapy.\n\nMeasurable disease as determined by RECIST v1.1.\n\nBC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n\nExclusion Criteria:\n\nPrevious treatment with a CDK2 inhibitor at any time.\n\nPatients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n\nClinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.\n\nPresence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n\nFor the combination treatment:\n\nPatients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nPatients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.\n\nFor patients with BC: Patient is concurrently using hormone replacement therapy.\n\nWOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":20,"type":21},[24,25],[28,29],[32,33,34,35,36],"2026-06-18",{"date":112,"type":42},"2026-06-23",{"date":44,"type":42},{"date":46,"type":21},{"name":48,"class":49},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100621173","phase-2-study-of-sacituzumab-govitecan-with-atropine-to-improve-tolerability-in-advanced-tnbc-and-hrher2--breast-cancer-100621173","NCT07367178","Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+\u002FHER2- Breast Cancer","Phase II Study to Improve Sacituzumab Govitecan Tolerance With Atropine in Patients With Advanced Triple-Negative and Hormone Receptor-Positive\u002FHER2-Negative Breast Cancer","SATROPIN","Inclusion Criteria:\n\n1. Participant, or legal representative (if applicable), must be capable of understanding the purpose of the Study and have signed a written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male participants ≥ 18 years of age at the time of signing ICF.\n3. ECOG performance status of 0 or 1.\n4. Minimum life expectancy of ≥ 12 weeks at screening.\n5. Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to curative therapy.\n6. For TNBC participants only:\n\n   i. Histologically confirmed TNBC of the most recent available sample per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) 2018 criteria on the most recently analyzed biopsy. TNBC status is defined as \\\u003C1% expression for estrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2) (0-1+ by immunohistochemistry \\[IHC\\] or 2+ and negative by in situ hybridization \\[ISH\\] test).\n7. For HR(+)\u002FHER2(-) breast cancer participants only:\n\n   i. Histologically confirmed HR(+)\u002FHER2(-) breast cancer of the most recent available sample per ASCO\u002FCAP 2018 criteria on the most recently analyzed biopsy. HR(+)\u002FHER2(-) status is defined as ≥1% expression for ER and\u002For PgR and negative for HER2 (0-1+ by IHC or 2+ and negative by ISH test).\n\n   ii. Disease progression to at least one prior endocrine therapy for advanced disease.\n\n   iii. Disease progression to previous CDK4\u002F6i-based therapy in any setting. For participants who received CDK4\u002F6i in the adjuvant setting, a minimum of one year of treatment and a disease-free interval (DFI) of ≤12 months are required.\n\n   Note: For participants with ER-low positive tumor (defined as ER expression between 1% and 10%) previous therapy with CDK4\u002F6 inhibitors and\u002For endocrine therapy is permitted but not required.\n8. Disease progression to no more than two prior standard of care chemotherapy-based regimens for advanced disease (prior ADC will count as a chemotherapy-based regimen).\n\n   Note: Earlier adjuvant or neoadjuvant therapy for early breast cancer will be considered as one of the required prior regimens if the development of unresectable locally advanced or metastatic disease occurred within a 12-month period after treatment completion.\n9. Prior treatment with a trophoblast cell-surface antigen 2 (TROP2) ADC and\u002For topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor is only allowed in the (neo)adjuvant setting if the development of unresectable locally advanced or metastatic disease occurred at least 12 months after treatment completion.\n10. Measurable or non-measurable, but evaluable disease, as per RECIST v.1.1.\n11. Participants must have adequate bone marrow, liver, and renal function:\n\n    i. Adequate hematologic counts without transfusion or growth factor support within two weeks before of study drug initiation (hemoglobin ≥ 9 g\u002FdL, ANC ≥ 1500\u002Fmm3, and platelets ≥ 100,000\u002F μL).\n\n    ii. Adequate renal and hepatic function (creatinine clearance of ≥ 60 ml\u002Fmin, may be calculated using Cockcroft-Gault equation; bilirubin ≤ 1.5 x ULN and AST\u002FALT ≤ 3.0 x ULN or 5 x ULN if known liver metastases).\n\n    Note: Participants with a known or genetically confirmed Gilbert's syndrome (based on UGT1A1 polymorphism testing) may be enrolled provided that total bilirubin is \\\u003C1.5 × ULN. The diagnosis of Gilbert's syndrome must be recorded in the patient's medical history, and if UGT1A1 status is available, the type of mutation should also be documented.\n12. Participants must be willing to provide the most recent archival tumor tissue sample (from the primary breast tumor or a metastatic site) at baseline, as well as biological samples (blood and stool) at the established time points.\n13. Resolution of all acute toxic effects of prior anticancer therapy to grade ≤1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v.6.0) (except for alopecia or other toxicities not considered a safety risk for the participant at investigator's discretion).\n14. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before Study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until six months after the last dose of Study treatment. Female participants must refrain from egg cell donation and breastfeeding during this same period.\n15. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until three months after the last administration of Study treatment. Male participants must not donate or bank sperm during this same period.\n16. Participants must be accessible for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial, interventional or observational, until the Study's safety visit.\n\n   Note: Participation in retrospective studies or data analysis is allowed.\n2. Known leptomeningeal disease or active uncontrolled or symptomatic central nervous system (CNS) metastases as indicated by clinical symptoms, and\u002For progressive growth are excluded.\n\n   Note: Participants with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before the first dose of Study treatment.\n3. Have a concurrent malignancy or malignancy within three years of Study enrollment with the exception of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.\n4. Known allergy or hypersensitivity reaction to any investigational medicinal product(s) (IMP\\[s\\]) or its (their) incorporated substances.\n5. Participants at risk of urinary retention (e.g.,those with prostatic hypertrophy), prior history of glaucoma, both open and closed angle, and previous diagnosis of myasthenia gravis, conditions in which atropine is contraindicated.\n6. Requirement for ongoing therapy with any prohibited medications listed in the protocol.\n7. Have received prior radiotherapy within two weeks before the first dose of Study treatment (four weeks in case of radiation therapy of the central nervous system). Participants must have recovered from all radiation-related toxicities, not require steroids.\n8. Major surgical procedure or significant traumatic injury within 14 days before the first dose of Study treatment or anticipation of need for major surgery within the course of the Study treatment.\n9. Known history of unstable angina, myocardial infarction, or cardiac heart failure present within six months of study initiation or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or history of QT interval prolongation.\n10. Clinically significant active pulmonary compromise at screening (e.g., ongoing infection, uncontrolled COPD\u002Fasthma exacerbation).\n\n    Note: Participants with stable chronic lung diseases (e.g., controlled COPD, asthma, bronchiectasis, post-COVID fibrosis) may be enrolled but atropine should be used with caution and participants should be monitored for respiratory complications.\n11. Known history of clinically significant bleeding, thrombosis, intestinal obstruction, or gastrointestinal perforation within six months of study initiation.\n12. Documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade ≥1 diarrhea).\n13. Any other serious medical condition and\u002For abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the participant's safe participation in and completion of the Study.\n14. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n15. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection.\n\n    i. Note: Participants with HIV on antiretroviral therapy (ART) with well-controlled HIV infection\u002Fdisease are allowed.\n\n    ii. Participants on ART must have a CD4+ T-cell count ≥ 350 cells\u002Fmm3 at time of screening.\n\n    iii. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies\u002FmL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening.\n\n    iv. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to Study entry.\n\n    v. The combination of the ART regimen must not contain any medications that may interfere with SN-38 metabolism (such as CYP3A4 inhibitors or inducers as raltegravir, nevirapine, or atazanavir).\n16. Other active uncontrolled infection at the time of enrollment.\n17. Receipt of live or attenuated vaccine within 30 days prior to the first dose of Study treatment.\n18. Pregnant or lactating women or participants not willing to apply highly effective contraception as defined in the protocol.\n19. Treatment with approved or investigational cancer therapy within 14 days prior to initiation of Study treatment.",{"count":125,"type":21},30,[25],"The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) or hormone receptor-positive\u002FHER2-negative (HR(+)\u002FHER2-) treated with sacituzumab govitecan.",[93,28,129],"Advanced Triple-Negative Breast Cancer",[131,132,133,134,135,136,122],"Advanced TNBC","Sacituzumab govitecan","Atropine","Tolerance","Advanced HR+\u002FHER2-","Prophylaxis","NOT_YET_RECRUITING","2026-01-26",{"date":140,"type":42},"2026-01-28",{"date":142,"type":21},"2026-07",{"date":144,"type":21},"2028-01",{"name":146,"class":147},"MedSIR","OTHER"]