[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-breast-cancer":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100511921","destiny-breast-respond-her2-ultralow-europe-100511921",false,"NCT05945732","DESTINY Breast Respond HER2-(Ultra)Low Europe","A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-(Ultra)Low Expressing Unresectable and\u002For Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-(Ultra)Low Europe)","Inclusion Criteria:\n\nStudy Group 1 and Study Group 2\n\n* Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and\u002For mBC\n* Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC\n* Written and signed Informed Consent to participate in the study\n\nStudy Group 1\n\n* Documented HER2-low status (IHC1+, IHC2+\u002FISH-)\n* Patients who have received prior chemotherapy in the metastatic setting or\n* Patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy\n\nStudy Group 2:\n\n* Documented HR+ status\n* Documented HER2-low status (IHC1+ or IHC2+\u002FISH-) or HER2-ultralow (defined as IHC 0 with membrane staining \\[IHC \\> 0 to \\\u003C1+\\]) status\n* Patients who have received at least one endocrine therapy in the metastatic setting\n* Patients who have NOT received prior chemotherapy in the metastatic setting\n\nExclusion Criteria:\n\nStudy Group 1 and Study Group 2\n\n* Pregnancy or breastfeeding\n* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.\n\nNo other specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.","ALL","18 Years",{"count":19,"type":20},2295,"ESTIMATED","OBSERVATIONAL","Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.\n\nBased on the extended therapeutic indication of Trastuzumab deruxtecan (Enhertu®), a new patient population will be enrolled, comprising adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.",[24,25,26,27],"Unresectable Breast Cancer","Metastatic Breast Cancer","HER2-low Expressing Breast Cancer","HER2-(Ultra)Low Expressing Breast Cancer",[24,25,26,29,30,31],"Trastuzumab Deruxtecan","Enhertu®","HER2-(ultra)low Expressing Breast Cancer","RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2023-10-24",{"date":40,"type":20},"2030-12-31",{"name":42,"class":43},"Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company","INDUSTRY",211,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100607810","phase-2-tucatinib-and-trastuzumab-in-her3-mutant-and-her2-not-amplified-metastatic-breast-cancer-100607810","NCT07193394","Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer","Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer: a Proof of Concept Study (H3RAKLES)","H3RAKLES","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Metastatic or unresectable breast cancer\n* HER2-negative (defined as having an IHC 0+, IHC 1+, or IHC 2+ and ISH non-amplified, per ASCO\u002FCAP guidelines) on last assessable tumor sample\n* Having received ≥ 2 previous chemotherapy lines for advanced breast cancer: including at least one line of conjugated antibody, at the investigator's discretion or if a germinal BRCA mutation is present, a PARP inhibitor.\n* Class IV or V somatic ERBB3 mutation as determined on a tumor sample obtained during the molecular screening step\n* ECOG performance status ≤ 2 (Appendix A)\n* Evaluable disease, per RECIST v1.1 inclusion criteria\n* Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 4 weeks prior to first dose of study treatment\n* Adequate organ function:\n\n  1. Creatinine clearance ≥ 50 mL\u002Fmin as calculated per institutional guidelines\n  2. Total bilirubin ≤1.5 X upper limit of normal (ULN), except for patients with known Gilbert's disease, who may enroll if the conjugated bilirubin is ≤1.5 X ULN.\n  3. Transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 2.5 X ULN (≤ 5 X ULN if the patient has liver metastases)\n* Women of childbearing potential (WCBP) must have a negative serum pregnancy test \\\u003C 7 days prior to first dose of treatment. A woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as the absence of menses for 12 months without an alternative cause.\n* WCBP (as defined above) and men with partners of childbearing potential must agree to use a highly effective birth control method during the study and for 3 months after completion of investigational treatment.\n* Patients should be eligible for the treatment step according to the investigator's opinion.\n* Patients must be covered by a health insurance plan.\n* Patients able to provide signed informed consent.\n\nExclusion Criteria:\n\n* Having received any prior treatment targeting HER2. Prior treatment with trastuzumab deruxtecan is allowed, per label, in patients with HER2-low metastatic breast cancer (IHC 1+ or 2+, ISH non-amplified)\n* History of allergic reactions to trastuzumab or tucatinib or chemically similar drugs\n* Patients who are pregnant, breastfeeding, or planning a pregnancy from time of informed consent until 7 months after the final dose of study drug\n* Inability to swallow pills or having a significant gastro-intestinal disease or a history of surgery which would preclude the adequate oral absorption of medications\n* Having used a strong CYP2C8 inhibitor within a duration of 5 half-lives prior to the first dose of study treatment, or have used a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment (see Appendix B and Appendix C)\n* Treatment with any systemic anti-cancer therapy (including hormonal therapy), non-central nervous system (CNS) radiation, or experimental agent ≤ 3 weeks prior to the first dose of study treatment, except gonadotropin releasing hormone (GnRH) agonists\n* Participation in another interventional clinical trial.\n* Symptomatic and untreated brain metastases or brain metastases requiring urgent treatment, or brain metastases requiring a dose \\> 2 mg of dexamethasone (or equivalent)\n* Whole brain radiotherapy \\\u003C 21 days prior to first dose of treatment, stereotactic radiotherapy \\\u003C 7 days prior to first dose of treatment\n* Leptomeningeal metastases\n* Major surgery (including surgery of brain metastases) \\\u003C 21 days prior to first dose of treatment\n* Evidence within 2 years of the start of study treatment of another malignancy that required systemic treatment\n* Have known myocardial infarction or unstable angina within 24 weeks prior to first dose of study treatment\n* Have clinically significant cardiopulmonary disease such as:\n\n  * Ventricular arrhythmia requiring therapy,\n  * Uncontrolled hypertension (defined as persistent systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\> 100 mm Hg on antihypertensive medications)\n  * Any history of symptomatic congestive heart failure\n  * Severe dyspnea at rest (CTCAE v5.0 Grade 3 or above) due to complications of advanced malignancy\n  * Hypoxia requiring supplementary oxygen therapy except when oxygen therapy is needed only for obstructive sleep apnea\n  * Presence of ≥ Grade 2 QTc prolongation on screening ECG\n* Conditions potentially resulting in drug-induced prolongation of the QT interval or torsade de pointes:\n\n  * Congenital or acquired long QT syndrome\n  * Family history of sudden death\n  * History of previous drug-induced QT prolongation\n  * Current use of medications with known and accepted associated risk of QT prolongation (see row \"Accepted Association\" in Appendix D)\n* Are known carriers of active Hepatitis B or Hepatitis C or have other known chronic liver disease\n* Are known to be positive for human immunodeficiency virus (HIV)\n* Altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.\n* Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons\n* Person deprived of liberty or under guardianship",{"count":54,"type":20},20,"INTERVENTIONAL",[57],"PHASE2","The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy. Patients included in this trial will have already received at least two lines of chemotherapy (and potentially several lines of endocrine therapy for patients with a HR+ disease). In this setting, few treatments have demonstrated a clinically meaningful benefit, and any additional option is valuable. Furthermore, the pre-clinical and clinical rationale indicate a high probability of clinical benefit, as previously shown in Table 1, with all patients treated with trastuzumab and a TKI targeting HER2 displaying a response. Besides, with several years of hindsight for the combination of lapatinib, trastuzumab and capecitabine, we expect excellent tolerance with the same treatment without capecitabine.\n\nThe H3RAKLES single-arm phase II trial will evaluate the combination of tucatinib, a HER2 TKI, and trastuzumab, a HER2-directed antibody in patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation. To demonstrate the actionability of ERBB3 mutations, all patients will receive a combination of trastuzumab and tucatinib, in 3-weeks cycles.",[60,24],"Metastatic Breast Cancer ( HER2 Negative)",[62,63,64,65,66,67,68,69],"Breast","Cancer","HER2","tucatinib","trastuzumab","HER3","metastatic","unresectable","2026-02-20",{"date":72,"type":36},"2026-02-23",{"date":74,"type":20},"2026-01-31",{"date":76,"type":20},"2029-06-08",{"name":78,"class":79},"Institut Curie","OTHER",9,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":55,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100514326","better-biomarker-driven-early-therapeutic-selection-in-patients-with-hr-her2--metastatic-or-unresectable-breast-cancer-100514326","NCT05977036","BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer","Inclusion Criteria - Patients\n\n* Diagnosis of metastatic or advanced unresectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative.\n* Planned to initiate standard of care first-line therapy with FDA-approved endocrine therapy plus CDK4\u002F6 inhibitor for the stated diagnosis at the time of study enrollment. Ribociclib is the preferred CDK4\u002F6 inhibitor. In the event this drug cannot be obtained due to insurance authorization or if there are specific side effect profile concerns from the treating physician, an alternative CDK4\u002F6 inhibitor is allowed.\n* Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.\n* Prior receipt of adjuvant CDK 4\u002F6 inhibitor therapy is permitted provided therapy completion occurred \\> 12 months prior to study enrollment.\n* Presence of RECIST-evaluable disease. Patients with bone-only disease are eligible.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Post-menopausal status, defined as one of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more\n  * Status post bilateral oophorectomy, total hysterectomy\n  * Pre- or peri-menopausal with suppressed ovarian function by use of GnRH agonist\u002Fantagonist or surgical bilateral oophorectomy\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria - Patients\n\n* Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limit to chemotherapy use in the neoadjuvant or adjuvant setting.\n* Patients with a prior or concurrent malignancy are excluded unless that malignancy's natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.\n\nEligibility Criteria - Physicians\n\n* Medical Oncologist at Siteman Cancer Center.\n* Treating patients with metastatic or advanced unresectable breast cancer.\n* Willing to complete Physician Surveys during participation.",{"count":88,"type":20},65,[90],"NA","This is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity (\"DiviTum® TKa\") in patients with HR positive, HER-2 negative metastatic or unresectable breast cancer. Patients will receive first-line treatment with a CDK4\u002F6 inhibitor (CDK4\u002F6i) and endocrine therapy. All patients will have blood drawn for thymidine kinase activity (TKa) testing at baseline and at C1D15. Patients who are found to have a lack of TKa suppression at C1D15 will be recommended to switch to an alternative therapy. Patients with suppressed C1D15 TKa levels will continue on CDK4\u002F6i and endocrine therapy until clinical progression. Patients with TKa which remains suppressed will be recommended to delay restaging scans from 24 weeks to 36 weeks.\n\nThe investigators hypothesize that a patient's TKa level at C1D15 is prognostic for progression-free survival (PFS) on a CDK4\u002F6 inhibitor and early therapeutic switching in patients with a lack of C1D15 TKa suppression will be associated with prolonged PFS.",[25,24],[94,95,96],"ER+ HER2- metastatic breast cancer","biomarkers","thymidine kinase","2025-12-11",{"date":99,"type":36},"2025-12-17",{"date":101,"type":36},"2024-09-25",{"date":103,"type":20},"2034-09-30",{"name":105,"class":79},"Washington University School of Medicine",1]