이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

이전에 진행성 또는 전이성 HER2 양성 유방암을 치료한 적이 있는 뇌 전이 유무에 관계없이 참가자의 T-DXd에 대한 연구 (DESTINY-B12)

2026년 11월 9일 업데이트: AstraZeneca

이전에 치료받은 진행성/전이성 HER2 양성 유방암(DESTINY-Breast12)이 있는 기준선 뇌 전이가 있거나 없는 환자에서 Trastuzumab Deruxtecan에 대한 공개, 다국적, 다기관, 3b/4상 연구.

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

연구 개요

상태

상태

현재 모집 상태 또는 확장 액세스 상태를 나타냅니다.
모집하지 않고 적극적으로

정황

정황

연구 중인 질병, 장애, 증후군, 질환 또는 부상입니다. ClinicalTrials.gov에서 조건에는 수명, 삶의 질 및 건강 위험과 같은 기타 건강 관련 문제도 포함될 수 있습니다.

개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.

상세 설명

Approximately 500 eligible participants will be enrolled into 1 of 2 cohorts (250 participants in each cohort) according to the presence or absence of BMs at baseline. Cohort 1 will include participants without BM at baseline and Cohort 2 will consist of participants with BM at baseline.

After study intervention discontinuation, all participants will undergo an end-of-treatment visit (within 7 days of discontinuation) and will be followed up for safety assessments 40 (+ up to 7) days after the discontinuation of all study intervention.

All participants will be followed up for survival status and duration of treatment on subsequent therapies after intervention discontinuation every 3 months (± 14 days) from the date of the safety follow-up until death, withdrawal of consent, or the end of the study, as per defined in the protocol.

연구 유형

연구 유형

임상 연구의 특성을 설명합니다. 연구 유형에는 중재 연구(임상 시험이라고도 함), 관찰 연구(환자 등록 포함) 및 확장된 액세스가 포함됩니다.
중재적

등록 (실제)

등록

임상 연구의 참가자 수. "예상" 등록은 연구원이 연구에 필요한 참가자의 목표 수입니다.
506

단계

단계

미국 식품의약국(FDA)에서 개발한 정의에 따라 약물 또는 생물학적 제품을 연구하는 임상 시험 단계입니다. 이 단계는 연구의 목적, 참가자 수 및 기타 특성을 기반으로 합니다. 초기 1단계(이전에는 0단계로 나열됨), 1단계, 2단계, 3단계 및 4단계의 5단계가 있습니다. 해당 없음은 장치 또는 행동 개입의 시험을 포함하여 FDA에서 정의한 단계가 없는 시험을 설명하는 데 사용됩니다.
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 네덜란드
      • Maastricht, 네덜란드, 6229 HX
        • Research Site
      • The Hague, 네덜란드, 2545 AA
        • Research Site
  • 노르웨이
      • Bergen, 노르웨이, 5009
        • Research Site
      • Oslo, 노르웨이, 450
        • Research Site
      • Oslo, 노르웨이, N-0379
        • Research Site
  • 덴마크
      • Copenhagen, 덴마크, 2100
        • Research Site
      • Herlev, 덴마크, 2730
        • Research Site
      • Odense C, 덴마크, 5000
        • Research Site
  • 독일
      • Berlin, 독일, 13125
        • Research Site
      • Dresden, 독일, 1307
        • Research Site
      • Erlangen, 독일, 91054
        • Research Site
      • Essen, 독일, 45136
        • Research Site
      • Frankfurt, 독일, 60389
        • Research Site
      • Hamburg, 독일, 20246
        • Research Site
      • Hanover, 독일, 30625
        • Research Site
      • Kiel, 독일, 24105
        • Research Site
      • Mannheim, 독일, 68167
        • Research Site
      • München, 독일, 80336
        • Research Site
      • München, 독일, 80637
        • Research Site
      • Münster, 독일, 48149
        • Research Site
      • Tübingen, 독일, 72076
        • Research Site
  • 미국
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • Research Site
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • Research Site
  • 벨기에
      • Anderlecht, 벨기에, 1070
        • Research Site
      • Bruges, 벨기에, 8000
        • Research Site
      • Leuven, 벨기에, 3000
        • Research Site
      • Liège, 벨기에, 4000
        • Research Site
  • 스웨덴
      • Gothenburg, 스웨덴, 413 45
        • Research Site
      • Lund, 스웨덴, 221 85
        • Research Site
      • Uppsala, 스웨덴, 751 85
        • Research Site
  • 스위스
      • Basel, 스위스, 4031
        • Research Site
      • Bellinzona, 스위스, CH-6500
        • Research Site
      • Lausanne, 스위스, 1011
        • Research Site
      • Lucerne, 스위스, 6000
        • Research Site
  • 스페인
      • Barcelona, 스페인, 08036
        • Research Site
      • Barcelona, 스페인, 8035
        • Research Site
      • Bilbao (Vizcaya), 스페인, 48013
        • Research Site
      • Granada, 스페인, 18014
        • Research Site
      • Madrid, 스페인, 28034
        • Research Site
      • Madrid, 스페인, 28041
        • Research Site
      • Madrid, 스페인, 28005
        • Research Site
      • Salamanca, 스페인, 37007
        • Research Site
      • Santander, 스페인, 39008
        • Research Site
      • Santiago de Compostela-Coruña, 스페인, 15706
        • Research Site
      • Seville, 스페인, 41013
        • Research Site
      • Valencia, 스페인, 46009
        • Research Site
  • 아일랜드
      • Cork, 아일랜드, T12 DV56
        • Research Site
      • Dublin, 아일랜드, 7
        • Research Site
      • Dublin, 아일랜드, D04 Y8V0
        • Research Site
  • 영국
      • Edinburgh, 영국, EH4 2XR
        • Research Site
  • 이탈리아
      • Ancona, 이탈리아, 60122
        • Research Site
      • Bergamo, 이탈리아, 24127
        • Research Site
      • Catania, 이탈리아, 95126
        • Research Site
      • Milan, 이탈리아, 20132
        • Research Site
      • Naples, 이탈리아, 80131
        • Research Site
      • Padova, 이탈리아, 35128
        • Research Site
      • Prato, 이탈리아, 59100
        • Research Site
  • 일본
      • Isehara, 일본, 259-1193
        • Research Site
      • Kawasaki-shi, 일본, 216-8511
        • Research Site
      • Sapporo, 일본, 003-0804
        • Research Site
      • Shinagawa-ku, 일본, 142-8666
        • Research Site
      • Yokohama, 일본, 241-8515
        • Research Site
  • 캐나다
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V5Z 1H7
        • Research Site
    • Ontario
      • Toronto, Ontario, 캐나다, M4N 3M5
        • Research Site
  • 포르투갈
      • Lisbon, 포르투갈, 1649-035
        • Research Site
      • Lisbon, 포르투갈, 1400-048
        • Research Site
      • Porto, 포르투갈, 4099-001
        • Research Site
  • 폴란드
      • Gdansk, 폴란드, 80-214
        • Research Site
      • Krakow, 폴란드, 31-501
        • Research Site
      • Opole, 폴란드, 45-060
        • Research Site
      • Warsaw, 폴란드, 02-781
        • Research Site
      • Warsaw, 폴란드, 04-141
        • Research Site
  • 핀란드
      • Helsinki, 핀란드, 00290
        • Research Site
      • Tampere, 핀란드, FI-33521
        • Research Site
      • Turku, 핀란드, 20520
        • Research Site
  • 호주
      • Adelaide, 호주, 5000
        • Research Site
      • Auchenflower, 호주, 4066
        • Research Site
      • Clayton, 호주, 3168
        • Research Site
      • Heidelberg, 호주, 3084
        • Research Site
      • St Leonards, 호주, 2065
        • Research Site
      • Subiaco, 호주, 6008
        • Research Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

자격 기준

임상 연구에 참여하고자 하는 사람들이 충족해야 하는 주요 요구 사항 또는 그들이 가져야 할 특성. 자격 기준은 포함 기준(사람이 연구에 참여하는 데 필요함)과 제외 기준(사람이 참여하지 못하게 하는 것)으로 구성됩니다. 적격성 기준 유형에는 연구가 건강한 지원자를 받아들이는지, 연령 또는 연령 그룹 요구 사항이 있는지 또는 성별에 따라 제한되는지가 포함됩니다.

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion:

  • Participants should have pathologically documented breast cancer that is: unresectable/advanced or metastatic; confirmed HER2-positive status expression as determined according to American Society of Clinical Oncology/College of American Pathologists guidelines
  • Participant must have either: no evidence of BM, or untreated BM on screening contrast brain magnetic resonance imaging/ computed tomography (MRI/CT) scan, not needing immediate local therapy or previously-treated stable or progressing BM
  • Participants with BMs must be neurologically stable
  • For participants requiring radiotherapy due to BMs, there should be an adequate washout period before day of first dosing:
  • ≥ 7 days since stereotactic radiosurgery or gamma knife
  • ≥ 21 days since whole brain radiotherapy
  • Eastern Cooperative Oncology Group performance status 0-1
  • Previous breast cancer treatment: radiologic or objective evidence of disease progression on or after HER2 targeted therapies and no more than 2 lines/regimens of therapy in the metastatic setting
  • Participant with the following measurable: at least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with CT or MRI and is suitable for accurate repeated measurements; or following Non-measurable diseases: Non-measurable, bone-only disease that can be assessed by CT or MRI or X-Ray. Lytic or mixed lytic bone lesions that can be assessed by CT or MRI or X-ray in the absence of measurable disease as defined above is acceptable; Participants with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible; and Non-measurable CNS disease (Cohort 2 only)
  • Adequate organ and bone marrow function within 14 days before the day of first dosing as defined in the protocol
  • Left ventricular ejection fraction ≥ 50% within 28 days before enrollment
  • Negative pregnancy test (serum) for women of childbearing potential

Exclusion Criteria

  • Known or suspected leptomeningeal disease
  • Prior exposure to tucatinib treatment
  • Refractory nausea and vomiting, chronic gastrointestinal disease, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of T-DXd
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence
  • Based on screening contrast brain MRI/CT scan, participants must not have any of the following: any untreated brain lesions > 2.0 cm in size; ongoing use of systemic corticosteroids for control of symptoms of BMs; any brain lesion thought to require immediate local therapy; have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to BMs not withstanding CNS-directed therapy
  • Has spinal cord compression
  • Known active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. Participants with past or resolved hepatitis B virus infection are eligible, if negative for hepatitis B surface antigen and positive for anti-hepatitis B core antigen
  • Participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of T-DXd
  • Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (New York Heart Association Class II to IV)
  • History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue or inflammatory disorders
  • Prior exposure, without adequate treatment washout period before the day of first dosing, to chloroquine/hydroxychloroquine: < 14 days
  • Anticancer chemotherapy: immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy: < 3 weeks
  • < 6 weeks for nitrosoureas or mitomycin
  • Antibody-based anticancer therapy: < 4 weeks
  • Any concurrent anticancer treatment. Concurrent use of hormonal therapy for noncancer- related conditions is allowed
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline
  • Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation, radiation to the chest, or to more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
  • Participants with prior exposure to immunosuppressive medication within 14 days prior to first study dose
  • Participants with a known hypersensitivity to study intervention or any of the excipients of the product or other monoclonal antibodies

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔

참가자 그룹 / 팔

시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.
개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: Trastuzumab Deruxtecan

Participants with or without BM at baseline will receive intravenous (IV) T-DXd, 5.4 mg/kg, every 3 weeks (21-day cycle) until Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) defined radiological progression outside central nervous system, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.
의약품: Trastuzumab Deruxtecan

Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution.

다른 이름들:
  • 팜-트라스투주맙 데룩테칸-nxki

연구는 무엇을 측정합니까?

주요 결과 측정

주요 결과 측정

임상 연구 프로토콜에서 개입/치료의 효과를 평가하는 데 가장 중요한 계획된 결과 측정. 대부분의 임상 연구에는 하나의 주요 결과 측정이 있지만 일부는 둘 이상입니다.
결과 측정
측정값 설명
기간
Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline)
기간: From first dose (Day 1) to progression of disease (up to 2 years 7 months)

The ORR is defined as the percentage (%) of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
From first dose (Day 1) to progression of disease (up to 2 years 7 months)
Progression-free Survival (PFS) Rate at 12 Months in Cohort 2 (Participants With Brain Metastasis at Baseline)
기간: At 12 months

The PFS rate is the percentage of participants alive and free of disease progression at 12 months, estimated by the Kaplan-Meier method.
At 12 months

2차 결과 측정

2차 결과 측정

임상 연구 프로토콜에서 개입의 효과를 평가하기 위한 1차 결과 측정만큼 중요하지는 않지만 여전히 관심이 있는 계획된 결과 측정입니다. 대부분의 임상 연구에는 하나 이상의 2차 결과 측정이 있습니다.
결과 측정
측정값 설명
기간
Survival Rate at 12 Months
기간: At 12 Months

Survival rate is the percentage of participants alive at 12 months, estimated by the Kaplan-Meier method.
At 12 Months
Objective Response Rate in Cohort 2 (Participants With Brain Metastasis at Baseline)
기간: From first dose (Day 1) to progression of disease (up to 2 years 7 months)

The ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.
From first dose (Day 1) to progression of disease (up to 2 years 7 months)
Duration of Response (DoR)
기간: From the date of first documented confirmed response until date of documented progression (up to 2 years 7 months)

Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by ICR or death due to any cause.
From the date of first documented confirmed response until date of documented progression (up to 2 years 7 months)
Time to Progression
기간: From first dose (Day 1) to progression of disease (up to 2 years 7 months)

Time to progression by RECIST 1.1 per ICR is defined as the time from the date of the first dose of study intervention to the date of documented disease progression.
From first dose (Day 1) to progression of disease (up to 2 years 7 months)
Duration of Treatment on Subsequent Lines of Therapy
기간: From the date of first dose of a subsequent therapy until date of last dose of therapy (up to 2 years 7 months)

Duration of treatment on subsequent therapy is defined as the time from the date of first dose of a subsequent therapy until date of the last dose of that therapy.
From the date of first dose of a subsequent therapy until date of last dose of therapy (up to 2 years 7 months)
Second Progression-Free Survival Rate at 12 Months
기간: At 12 Months

Second progression-free survival rate is the percentage of participants alive and free from a second progression on next-line treatment at 12 months, estimated by the Kaplan-Meier method. The second progression is defined as the earliest progression event subsequent to the first anti-cancer therapy after the initial progression.
At 12 Months
Incidence of New Symptomatic Central Nervous System (CNS) Metastasis During Treatment Without CNS Metastasis at Baseline (Cohort 1)
기간: From first dose (Day 1) to end of treatment (up to 2 years 7 months)

The incidence rate is defined as proportion of participants with new symptomatic CNS metastases during treatment period in participants without symptomatic CNS metastasis at baseline.
From first dose (Day 1) to end of treatment (up to 2 years 7 months)
Time to Next Progression (CNS or Extracranial) or Death
기간: From date of first documented isolated CNS progression to the date of the next documented disease progression (up to 2 years 7 months)

The time to next progression is defined as the time from the date of the first documented isolated CNS progression to the date of the next documented disease progression (CNS or extracranial) per RECIST 1.1 or death and has been summarized descriptively in participants who have developed isolated CNS progression, receive local therapy, and continue on protocol therapy.
From date of first documented isolated CNS progression to the date of the next documented disease progression (up to 2 years 7 months)
Site (CNS vs Extracranial vs Both) of Next Progression
기간: From the date of the first documented isolated CNS progression to the date of the next documented CNS disease progression (up to 2 years 7 months)

Site of next progression (CNS [CNS RECIST 1.1] or extracranial [systemic RECIST 1.1] in participants who developed isolated CNS progression, received local therapy, and continued on protocol therapy.
From the date of the first documented isolated CNS progression to the date of the next documented CNS disease progression (up to 2 years 7 months)
Central Nervous System Progression-free Survival Rate at 12 Months in Participants With Brain Metastasis at Baseline (Cohort 2)
기간: At 12 Months

Central nervous system progression free survival rate is the percentage of participants free from central nervous system progression at 12 months, estimated by the Kaplan-Meier method.
At 12 Months
Time to New CNS Lesions in Participants With Brain Metastasis at Baseline (Cohort 2)
기간: From first dose (Day 1) to the date of documented new CNS lesions (up to 2 years 7 months)

The time to new CNS lesions is defined as the time from the date of the first dose of study intervention to the date of documented new CNS lesions by RECIST 1.1 per ICR.
From first dose (Day 1) to the date of documented new CNS lesions (up to 2 years 7 months)
Central Nervous System Objective Response Rate in Participants With Brain Metastasis at Baseline by ICR (Cohort 2)
기간: From first dose (Day 1) until CNS progression of disease (up to 2 years 7 months)

The CNS ORR is defined as the percentage of participants with measurable brain metastasis at baseline who have a confirmed CR or confirmed PR of brain lesions, as determined by ICR per CNS RECIST 1.1.
From first dose (Day 1) until CNS progression of disease (up to 2 years 7 months)
Central Nervous System Duration of Response in Participants With Brain Metastasis at Baseline (Cohort 2)
기간: From date of first documented confirmed CNS response until CNS progression of disease (up to 2 years 7 months)

The CNS DoR is defined as the time from the date of first documented confirmed CNS response until date of documented CNS progression per CNS RECIST 1.1 as assessed by ICR or death due to any cause.
From date of first documented confirmed CNS response until CNS progression of disease (up to 2 years 7 months)
Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)
기간: Time from first dose up to 47 days after last dose, or prior to starting any subsequent therapy, or for up to 2 years 7 months, whichever occurred first

The EORTC QLQ-C30 is a 30-item questionnaire for cancer assessment. Increased scores indicate improvement; decreased scores indicate deterioration. Physical function: ≥+9= improvement, ≤-10=deterioration, otherwise=no change; Role functioning: ≤-6=deterioration, otherwise=no change; Social functioning: ≥+8=improvement, ≤-7=deterioration, otherwise=no change; Cognitive functioning: ≥+ 5=improvement, ≤- 4=deterioration, otherwise=no change; Global Health Status: ≥+2=improvement, ≤-8=deterioration, otherwise=no change; Fatigue: ≥+8=improvement, ≤-8=deterioration, otherwise=no change; Nausea and vomiting: ≤-11=deterioration, otherwise=no change; Appetite loss: ≤-14=deterioration, otherwise=no change; rest of scales: ≥+10=improvement, ≤-10=deterioration, otherwise=no change. Best on treatment response is best response category (improvement, no change, and deterioration) achieved by participants between first dose and 47 days after last dose, and prior to starting any anticancer therapy.
Time from first dose up to 47 days after last dose, or prior to starting any subsequent therapy, or for up to 2 years 7 months, whichever occurred first
Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale)
기간: Time from first dose up to 47 days after last dose, or prior to starting any subsequent therapy, or for up to 2 years 7 months, whichever occurred first

The NANO scale is a clinician-reported assessment of neurologic functioning in neuro-oncology participants. The instrument captures 9 domains (gait, strength, ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior) and was developed to provide a simple, objective assessment of neurologic function that would be combined with radiographic assessment to provide an overall outcome assessment for neuro-oncology participants in clinical trials and in daily practice. The soring scale for Gait consists of score range 0-3, Strength consists of score range 0-2, ataxia (upper extremity) consists of scale range 0-2 and sensation as 0. Higher scores indicate worse neurologic function. The response categories reported are changes from first post-baseline score to worst on-treatment score at any point of treatment.
Time from first dose up to 47 days after last dose, or prior to starting any subsequent therapy, or for up to 2 years 7 months, whichever occurred first
Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS)
기간: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)

The PAL is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included PAL and was a low-burden, highly sensitive, precise measure of cognitive function. The PALFAMS is the number of times a participant chose the correct box on their first attempt when recalling the pattern locations, calculated across all assessed trials. A higher number of events of selecting correct boxes indicates better cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA)
기간: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)

The PAL is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included PALTEA and was a low-burden, highly sensitive, precise measure of cognitive function. PALTEA is the number of times a participant chose the incorrect box for a stimulus on assessment problems, plus an adjustment for the estimated number of errors they would have made on any problems, attempts, and recalls they did not reach. A higher number of events of selecting incorrect boxes indicates worse cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Cognitive Functions Tests: Reaction Time (RTI)
기간: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)

This is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included Reaction Time Task (RTI) and was low-burden, highly sensitive, precise measures of cognitive function. RTI Median Five-Choice Movement Time: median time taken for a participant to release response button and select target stimulus after it flashed yellow on screen. Calculated across correct, assessed trials in which stimulus could appear in any one of five locations. RTI Median Five-Choice Reaction Time: median duration it took for a participant to release response button after presentation of target stimulus. Calculated across correct, assessed trials in which stimulus could appear in any one of five locations. Measured in milliseconds. Higher reaction times indicate worse cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Cognitive Functions Tests: Spatial Working Memory (SWM)
기간: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)

The SWM is a computerized cognitive test. The SWM Between Errors (SWMBE) is number of times a participant incorrectly revisits a box in which a token has previously been found, calculated across all 4, 6, and 8 token trials. SWM Between Errors 4 Boxes (SWMBE4), SWM Between Errors 6 Boxes (SWMBE6), and SWM Between Errors 8 Boxes (SWMBE8) are number of times a participant revisits a box in which a token has previously been found. These are calculated across all trials with 4 tokens only for SWMBE4, 6 tokens only for SWMBE6, and 8 tokens only for SWMBE8. SWM Total Errors is number of times a box is selected that is certain not to contain a token and therefore should not have been visited by participant. A higher number of incorrect revisit events to previously found token boxes indicates worse cognitive function, and a lower number of revisit events indicates better cognitive function. Here, baseline was last non-missing value prior to administration of first dose of study intervention.
Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS)
기간: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)

The SWM is a computerized cognitive test. The SWMS, the number of times a participant restarted search patterns from the same initial box, indicating their use of a planned strategy to find tokens. An increased number of events where search patterns started from the same initial box suggested participants were using a planned strategy to find tokens, which indicated better cognitive function. Here, a low score indicated high strategy use (1 = they always began the search from the same box). Conversely, high scores represented a decrease in events of beginning searches from the same box. Instead, starting from many different boxes suggested the participant was not using a consistent strategy, which indicated worse cognitive function. This was calculated across assessed trials with 6 tokens or more. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis
기간: From time of ILD/pneumonitis diagnosis (every week) until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)

The effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline brain metastasis was evaluated. The SGRQ-I is an idiopathic pulmonary fibrosis-specific version of the instrument developed and validated for use among participants with idiopathic pulmonary fibrosis, a type of ILD. The SGRQ-I was used to assess the HRQoL among participants who have been diagnosed with ILD/pneumonitis. It includes 34 of the original SGRQ items determined to be most reliable for assessing the HRQoL of participants with idiopathic pulmonary fibrosis. The instrument yields 3 domain scores (symptoms, activity, and impact) as well as a total score, with scores ranging from 0 to 100. Higher scores indicate greater impairment in HRQoL.
From time of ILD/pneumonitis diagnosis (every week) until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)
MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants
기간: Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 39 Day 1 (21 days cycle)

The T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline brain metastasis was evaluated. The MDASI brain tumor module includes 9 symptoms specific to brain tumors (weakness on one side of the body, difficulty understanding, difficulty speaking, seizures, difficulty concentrating, problems with vision, change in appearance, change in bowel pattern (diarrhea or constipation), and irritability). These 9 items will be used to capture symptoms associated with brain metastasis for those diagnosed with brain metastasis. Each item is rated on an 11-point numeric rating scale on a scale of 0-10, with higher scores indicating greater symptom severity. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 39 Day 1 (21 days cycle)
Number of Participants With Adverse Events (AEs)
기간: From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)

The safety and tolerability of the participants who received T-DXd was evaluated.

SAE=Serious adverse events; CTCAE=Common Terminology for Adverse Events
From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)
Number of Participants With Investigator-assessed ILD/Pneumonitis
기간: From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)

The number of participants with ILD/Pneumonitis were by grouped term based on Investigator-reported preferred terms. No adjudication was performed.
From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)
Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid
기간: From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)

The number of participants with ILD clinical symptoms resolution in ILD/Pneumonitis participants who have been treated with high dose steroid (>2 mg dexamethasone) were evaluated.
From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

스폰서

연구를 시작하고 연구에 대한 권한과 통제권을 가진 조직 또는 사람.
AstraZeneca

협력자

협력자

임상 연구를 지원하는 스폰서 이외의 조직. 이 지원에는 자금 조달, 설계, 구현, 데이터 분석 또는 보고와 관련된 활동이 포함될 수 있습니다.
Daiichi Sankyo

수사관

수사관

임상 연구에 참여하는 연구원. 관련 용어에는 사이트 주임 조사관, 사이트 하위 조사자, 연구 의자, 연구 책임자 및 연구 주임 조사관이 포함됩니다.
  • 수석 연구원: Nadia Harbeck, MD, PhD, Head, Breast Center, Ludwig-Maximilians-University of Munich Department of Obstetrics and Gynecology Marchioninistr. 15, 81377 Munich, Germany
  • 수석 연구원: Nancy U. Lin, MD, Associate Chief, Division of Breast Oncology, Susan F. Smith Center for Women's Cancers Director, Metastatic Breast Cancer Program, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

연구 시작

첫 번째 참가자가 임상 연구에 등록된 실제 날짜입니다. "예상" 연구 시작 날짜는 연구자가 연구 시작 날짜가 될 것이라고 생각하는 날짜입니다.
2021년 6월 22일

기본 완료 (실제)

기본 완료

임상 연구의 마지막 참가자가 1차 결과 측정을 위한 최종 데이터를 수집하기 위해 검사를 받거나 개입을 받은 날짜입니다. 임상 연구가 프로토콜에 따라 종료되었는지 또는 종료되었는지 여부는 이 날짜에 영향을 미치지 않습니다. 완료 날짜가 다른 1차 결과 측정이 둘 이상인 임상 연구의 경우 이 용어는 모든 1차 결과 측정에 대한 데이터 수집이 완료된 날짜를 나타냅니다. "예상" 기본 완료 날짜는 연구원이 연구의 기본 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2024년 2월 8일

연구 완료 (추정된)

연구 완료

임상 연구의 마지막 참가자가 1차 결과 측정, 2차 결과 측정 및 부작용(즉, 마지막 참가자의 마지막 방문)에 대한 최종 데이터를 수집하기 위해 검사를 받거나 중재/치료를 받은 날짜입니다. "예상" 연구 완료 날짜는 연구원이 연구 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2027년 5월 26일

연구 등록 날짜

최초 제출

최초 제출

연구 후원자 또는 연구자가 최초로 ClinicalTrials.gov에 연구 기록을 제출한 날짜. 일반적으로 처음 제출한 날짜와 ClinicalTrials.gov에서 기록을 사용할 수 있는 날짜(첫 게시 날짜) 사이에는 며칠의 지연이 있습니다.
2021년 1월 20일

QC 기준을 충족하는 최초 제출

QC 기준을 충족하는 최초 제출

연구 스폰서 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록을 처음 제출한 날짜입니다. 의뢰자 또는 조사자는 NLM의 QC 검토 기준이 충족되기 전에 연구 기록을 한 번 이상 수정하고 제출해야 할 수 있습니다. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2021년 2월 2일

처음 게시됨 (실제)

처음 게시됨

National Library of Medicine(NLM) 품질 관리(QC) 검토가 완료된 후 ClinicalTrials.gov에서 연구 기록을 처음 사용할 수 있는 날짜입니다. 일반적으로 연구 후원자 또는 연구자가 연구 기록을 제출한 날짜와 처음 게시된 날짜 사이에는 며칠의 지연이 있습니다.
2021년 2월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

마지막 업데이트 게시됨

ClinicalTrials.gov에서 연구 기록이 변경된 가장 최근 날짜. 연구 후원자 또는 연구자가 변경 사항을 ClinicalTrials.gov에 제출한 시점(마지막 업데이트 제출 날짜)과 마지막 업데이트 게시 날짜 사이에 지연이 있을 수 있습니다.
2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

QC 기준을 충족하는 마지막 업데이트 제출

연구 후원자 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록에 대한 변경 사항을 제출한 가장 최근 날짜. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2026년 11월 9일

마지막으로 확인됨

마지막으로 확인됨

연구 후원자 또는 조사자가 ClinicalTrials.gov에서 임상 연구에 대한 정보가 정확하고 최신 정보라고 확인한 가장 최근 날짜. 모집 상태가 모집인 연구인 경우; 아직 모집하지 않았습니다. 또는 활성, 비모집이 지난 2년 이내에 확인되지 않은 경우 연구의 모집 상태는 알 수 없음으로 표시됩니다.
2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

기타 연구 ID 번호

연구 후원자, 기금 제공자 또는 다른 사람이 임상 연구에 할당한 NCT 번호 이외의 식별자 또는 ID 번호. 이 번호에는 다른 시험 등록의 고유 식별자와 미국 국립보건원(National Institutes of Health) 보조금 번호가 포함될 수 있습니다.
  • D9673C00007
  • 2020-005048-46 (EudraCT 번호)
  • 2024-510588-53-00 (레지스트리 식별자: CTIS (EU))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 공유 기간

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 공유 액세스 기준

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

쿠키 설정

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