[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514759":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":35,"armGroups":43,"interventions":50,"overallOfficials":56,"centralContacts":61,"locations":70,"responsibleParty":87,"collaborators":89,"id":95,"slug":35,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":35,"enrollmentInfo":104,"targetDuration":35,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":72,"whyStopped":35,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Complete radiologic response","Number of patients to achieve radiologic response as defined by RECIST 11 with clearnace of ctDNA","up to one year after start treatment",[14,18,21,25,29,31],{"measure":15,"description":16,"timeFrame":17},"Number of patients free of progression","as defined by RECIST","assessed up to 10 years",{"measure":19,"description":20,"timeFrame":17},"Overall Survival","time from start treatment to death from any cause",{"measure":22,"description":23,"timeFrame":24},"Number of patients with pathological complete response","after resection of primary tumor and\u002For metastatic lesions after neo-adjuvant treatment","assessed immediately after surgery",{"measure":26,"description":27,"timeFrame":28},"Number of patients with metabolic response","as measured with PDG-PET","assessed up to 12 months",{"measure":26,"description":30,"timeFrame":17},"as measured by clearance of ctDNA",{"measure":32,"description":33,"timeFrame":34},"Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)","determined accoriding to CTCAE v5.0 or Clavien-Dindo (in case of surgical resection)","assessed up to 30 days after last treatment",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"NA","SINGLE_GROUP","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE","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. Given the basket-design of this trial other baskets for oligo-metastatic breast cancer can be added, such as but not limited to other breast cancer subtypes or with other promising drugs.\n\nBaskets for de novo oligo-metastatic disease I. ER+\u002FHER2+ II. ER-\u002FHER2+ Baskets for oligo-metastatic disease after prior chemo\u002Fanti-HER2 therapy for primary disease III. ER+\u002FHER2+ IV. ER-\u002FHER2+",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"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.",[49],"Drug: Trastuzumab deruxtecan",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":35},"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.",[45],[57],{"name":58,"affiliation":59,"role":60},"Marleen Kok, MD","Antoni van Leeuwenhoek","PRINCIPAL_INVESTIGATOR",[62,67],{"name":58,"role":63,"phone":64,"phoneExt":65,"email":66},"CONTACT","+31205129111","9111","m.kok@nki.nl",{"name":68,"role":63,"phone":69,"phoneExt":65,"email":35},"Robbert-Jan Gielen, MD","+3120512",[71],{"facility":59,"status":72,"city":73,"state":35,"zip":35,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Amsterdam","Netherlands","NL",{"type":77,"coordinates":78},"Point",[79,80],4.88969,52.37403,{"lat":80,"lon":79},[83,84,86],{"name":68,"role":63,"phone":35,"phoneExt":35,"email":35},{"name":85,"role":63,"phone":35,"phoneExt":35,"email":35},"Ingrid Mandjes, MSc",{"name":58,"role":60,"phone":35,"phoneExt":35,"email":35},{"type":88,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[90,93],{"name":91,"class":92},"Daiichi Sankyo","INDUSTRY",{"name":94,"class":92},"AstraZeneca","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":105,"type":106},72,"ESTIMATED","INTERVENTIONAL",[109],"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.",[112],"HER2-positive Breast Cancer",[114],"Oligometastatic disease (max 3 lesions)","2025-11-21",{"date":117,"type":118},"2025-11-26","ACTUAL",{"date":120,"type":118},"2024-05-02",{"date":122,"type":106},"2034-10-01",{"name":5,"class":6},1]