[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514759":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":54,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Trastuzumab-deruxtecan","EXPERIMENTAL","5.4mg\u002Fkg on a three weekly (21 day) basis, with the goal of 16 cycles leading to a treatment period of year, including local treatment. The first 8 cycles of T-DXd are administered neo-adjuvant, and 8 cycles adjuvant, after completion of local treatment.",[13],"Drug: Trastuzumab deruxtecan",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Trastuzumab deruxtecan","T-DXd 5.4mg\u002Fkg on a three weekly (21 day) basis, with the goal of 16 cycles leading to a treatment period of year, including local treatment. The first 8 cycles of T-DXd are administered neo-adjuvant, and 8 cycles adjuvant, after completion of local treatment.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Marleen Kok, MD","Antoni van Leeuwenhoek","PRINCIPAL_INVESTIGATOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+31205129111","9111","m.kok@nki.nl",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":20},"Robbert-Jan Gielen, MD","+3120512",[36],{"facility":24,"status":37,"city":38,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Amsterdam","Netherlands","NL",{"type":42,"coordinates":43},"Point",[44,45],4.88969,52.37403,{"lat":45,"lon":44},[48,49,51],{"name":33,"role":28,"phone":20,"phoneExt":20,"email":20},{"name":50,"role":28,"phone":20,"phoneExt":20,"email":20},"Ingrid Mandjes, MSc",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[55,58],{"name":56,"class":57},"Daiichi Sankyo","INDUSTRY",{"name":59,"class":57},"AstraZeneca","100514759","phase-2-basket-study-for-oligo-metastatic-breast-cancer-100514759",false,"NCT05982678","Basket Study for Oligo-metastatic Breast Cancer","Basket Study for Oligo-metastatic Breast Cancer Part 1: Trastuzumab-deruxtecan for HER2-positive Oligo-metastatic Breast Cancer","ANISE","Inclusion Criteria:\n\n* Histologic proof of infiltrating HER2-positive breast cancer (as determined by IHC 3+ and\u002For amplification by ISH)\\[8\\]\n* Histologic or cytologic proof of breast cancer metastases (at least one lesion)\n* Histologic determination of level of ER-expression\n* Oligo-metastatic disease as determined by standard of care diagnostics. The number of total individual distant metastases is limited to five, either in one organ or in 2-5 organ systems. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as single lesion. Pleuritis carcinomatosa, miliary spread of metastases (even within one organ), or peritoneal spread of metastases rules out oligo-metastatic disease and is not allowed. Initial staging by PET-CT (whole body) and MRI of breast and brain are mandatory, as is MRI liver or spine and pelvis in case of liver or bone metastases respectively.\n* In case of recurrent disease, a disease-free interval of 24 months.\n* Measurable disease according to RECIST1.1\n* Patients must be at least 18 years of age and be able to give written informed consent and comply with study procedures.\n* World Health Organization (WHO) performance status 0 or 1\n\nExclusion Criteria:\n\n* prior line of therapy for metastatic disease. Exceptions are endocrine therapy or radiation considered to be part of the curative treatment, within 3 months before enrolment\n* leptomeningeal disease or central nervous metastases\n* clinically relevant obstruction or compression of spinal cord, central nervous, gastro-intestinal or cardiovascular system, that cannot be alleviated before start of treatment.\n* other malignancy, unless treated with curative intention and a long-term survival probability of \\>95%, including in-situ or pre-malignant lesions.","ALL","18 Years",{"count":71,"type":72},72,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","The study will include patients with HER2-positive breast cancer and 1- 3 distant metastatic lesions, all amenable for curative intervention. Patients will be stratified by prior therapy and ER expression. In the initial baskets patients with be treated with trastuzumab-deruxtecan.\n\nPatients are treated with T-DXd 5.4mg\u002Fkg on a three weekly (21 day) basis, with the goal of 16 cycles leading to a treatment period of year, including local treatment. The first 8 cycles of T-DXd are administered neo-adjuvant, and 8 cycles adjuvant, after completion of local treatment.\n\nThe proposed M22BOL trial is based on an important knowledge gap for regarding breast cancer patients with 'oligo-metastatic' disease who are usually not included in clinical trials for patients with metastatic disease since loco-regional treatments (radiation, surgery) with curative intent is not allowed in clinical trials for metastatic breast cancer. Moreover, neo-adjuvant trial protocols for early breast cancer exclude patients with distant metastases that can be treated with curative intent. This basket trial evaluates T-DXd for oligo-metastatic breast cancer with the goal to induce deep responses and subsequently long-lasting disease remissions and potentially cure.",[78],"HER2-positive Breast Cancer",[80],"Oligometastatic disease (max 3 lesions)","2025-11-21",{"date":83,"type":84},"2025-11-26","ACTUAL",{"date":86,"type":84},"2024-05-02",{"date":88,"type":72},"2034-10-01",{"name":5,"class":6},1]