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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04739761
Registration number
NCT04739761
Ethics application status
Date submitted
20/01/2021
Date registered
5/02/2021
Date last updated
20/02/2024
Titles & IDs
Public title
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
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Scientific title
An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)
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Secondary ID [1]
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0
2020-005048-46
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Secondary ID [2]
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0
D9673C00007
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Universal Trial Number (UTN)
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Trial acronym
DESTINY-B12
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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0
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Condition category
Condition code
Cancer
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Breast
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Cancer
0
0
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0
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab Deruxtecan
Experimental: 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.
Treatment: Drugs: Trastuzumab Deruxtecan
Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) in Participants without BM at Baseline (Cohort 1)
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Assessment method [1]
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To describe the overall treatment effect of T- DXd in HER2-positive metastatic breast cancer (MBC) participants without baseline BM. An ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by independent central review (ICR) per RECIST 1.1.
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Timepoint [1]
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From screening until progression of disease [PD] (Up to 2.5 Years)
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Primary outcome [2]
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Progression-free Survival (PFS) in Participants with BM at Baseline (Cohort 2)
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Assessment method [2]
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To describe the overall treatment effect of T- DXd in HER2-positive MBC participants with baseline BM. The PFS will be defined as the time from the date of the first dose of study intervention until the date of objective PD per RECIST 1.1 as assessed by ICR or death.
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Timepoint [2]
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From screening until PD (Up to 2.5 Years)
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Secondary outcome [1]
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Overall Survival (OS) in Months
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Assessment method [1]
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To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. An OS is defined as the time from the date of the first dose of study intervention until death due to any cause.
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Timepoint [1]
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At safety F/U (40+7 days after last dose) visit, thereafter survival F/U q3months ± 14 days (Approximately 2.5 Years)
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Secondary outcome [2]
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Duration of Response (DoR)
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Assessment method [2]
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To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. The DoR will be 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.
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Timepoint [2]
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Screening Day (-28 days) until end-of-treatment (EOT) (Approximately 2.5 Years)
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Secondary outcome [3]
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Time to Progression
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Assessment method [3]
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To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. 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.
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Timepoint [3]
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Screening Day (-28 days) until PD (Approximately 2.5 Years)
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Secondary outcome [4]
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Duration of Treatment on Subsequent Lines of Therapy
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Assessment method [4]
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To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. Duration of treatment on subsequent therapy will be defined as the time from the date of first dose of a subsequent therapy until date of the last dose of that therapy.
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Timepoint [4]
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At safety follow-up (40+7 days after last dose) then survival F/U q3months ± 14 days (Approximately 2.5 Years)
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Secondary outcome [5]
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Time to Second Progression or Death (PFS2)
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Assessment method [5]
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To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. The PFS2 is defined as time from the first dose of study intervention to second progression (the earliest of the progression event subsequent to first subsequent therapy) or death.
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Timepoint [5]
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At safety F/U (40+7 days after last dose) visit, thereafter survival F/U q3months ± 14 days (Approximately 2.5 Years)
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Secondary outcome [6]
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Incidence of new Symptomatic Central Nervous System (CNS) Metastasis During Treatment in Participants without BM at Baseline (Cohort 1)
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Assessment method [6]
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To describe the treatment effect on the development and progression of BM in participants without baseline BM using additional efficacy measurements.
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Timepoint [6]
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At Screening day (-28 days), Cycle 1 (15 days ± 2 days) Day 1 and Cycle 3 (15 days ± 2 days) Day 1 and thereafter every 3 subsequent cycles (Approximately 2.5 Years)
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Secondary outcome [7]
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Time to Next Progression (CNS or extracranial) or Death
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Assessment method [7]
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To describe the treatment effect on the development and progression (central nervous system [CNS] progression) of BM in participants without baseline BM using additional efficacy measurements. 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 will be summarized descriptively in participants who develop isolated CNS progression, receive local therapy, and continue on protocol therapy.
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Timepoint [7]
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Screening Day (-28 days) until next PD (Approximately 2.5 Years)
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Secondary outcome [8]
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Site (CNS vs extracranial vs both) of Next Progression
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Assessment method [8]
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To describe the treatment effect on the development and progression (CNS progression) of BM in participants without baseline BM using additional efficacy measurements. Site of next progression will be summarized descriptively in participants who develop isolated CNS progression, receive local therapy, continue on protocol therapy, and have a subsequent documented disease progression (CNS or extracranial) per RECIST 1.1.
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Timepoint [8]
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Screening Day (-28 days) until next PD (Approximately 2.5 Years)
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Secondary outcome [9]
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Objective Response Rate in Participants with BM at Baseline (Cohort 2)
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Assessment method [9]
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To describe efficacy in participants with stable or untreated BM. An ORR will be evaluated by RECIST 1.1 per ICR.
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Timepoint [9]
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From screening until PD (Up to 2.5 Years)
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Secondary outcome [10]
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Central Nervous System Progression-free Survival in Participants with BM at Baseline (Cohort 2)
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Assessment method [10]
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To describe efficacy in participants with stable or untreated BM. The CNS PFS is defined as time from the first dose of study intervention to CNS progression per CNS RECIST 1.1 or death resulting from any cause, whichever occurs first.
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Timepoint [10]
0
0
At safety follow-up (40+7 days after last dose) then survival F/U q3months ± 14 days (Approximately 2.5 Years)
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Secondary outcome [11]
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Time to new CNS Lesions in Participants with BM at Baseline (Cohort 2)
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Assessment method [11]
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To describe efficacy in participants with stable or untreated BM. 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.
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Timepoint [11]
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Screening Day (-28 days) until EOT (Approximately 2.5 Years)
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Secondary outcome [12]
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Central Nervous System Objective Response Rate in Participants with BM at Baseline by ICR (Cohort 2)
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Assessment method [12]
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To describe efficacy in participants with stable or untreated BM. The CNS ORR is defined as the proportion of participants with measurable BM at baseline who have a confirmed CR or confirmed PR of brain lesions, as determined by ICR per CNS RECIST 1.1.
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Timepoint [12]
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Screening Day (-28 days) until EOT (Approximately 2.5 Years)
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Secondary outcome [13]
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Central Nervous System Duration of Response in Participants with BM at Baseline (Cohort 2)
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Assessment method [13]
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To describe efficacy in participants with stable or untreated BM. The CNS DoR will be 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.
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Timepoint [13]
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Screening Day (-28 days) until EOT (Approximately 2.5 Years)
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Secondary outcome [14]
0
0
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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Assessment method [14]
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To describe the effect of T-DXd on symptoms, functioning, and health-related quality of life (HRQoL) in HER2+ MBC participants with or without baseline BM.
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Timepoint [14]
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Cycle 1 (15 days ± 2 days) Day 1, thereafter every 3 weeks (q3w) until 24 weeks post EOT visit and prior to second progression, and at the EOT visit (Approximately 2.5 Years)
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Secondary outcome [15]
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Neurologic Assessment in Neuro-Oncology Scale
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Assessment method [15]
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To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
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Timepoint [15]
0
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Cycle 1 (15 days ± 2 days [Day 1]), Cycle 2 (15 days ± 2 days) Day 1, Cycle 3 (15 days ± 2 days) Day 1, Cycle 4 (15 days ± 2 days) Day 1 thereafter subsequent Cycles until PD and at EOT visit (Approximately 2.5 Years)
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Secondary outcome [16]
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Cognitive Functions Tests
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Assessment method [16]
0
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To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
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Timepoint [16]
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Cycle 1 (15 days ± 2 days) Day 1, thereafter q12w and at EOT visit (Approximately 2.5 Years)
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Secondary outcome [17]
0
0
MD Anderson Symptom Inventory Brain Tumor-specific Items
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Assessment method [17]
0
0
To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
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Timepoint [17]
0
0
Cycle 1 (15 days ± 2 days) Day 1, thereafter q3w until 24 weeks post EOT visit and prior to second progression, and at the EOT visit (Approximately 2.5 Years)
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Secondary outcome [18]
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0
St. George's Respiratory Questionnaire - idiopathic pulmonary fibrosis version in Participants with Interstitial Lung Disease (ILD)/Pneumonitis
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Assessment method [18]
0
0
To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
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Timepoint [18]
0
0
After diagnosis of ILD/pneumonitis and thereafter once weekly until EOT and safety F/U (40+7 days after last dose) (Approximately 2.5 Years)
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Secondary outcome [19]
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0
Number of Participants with Adverse Events
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Assessment method [19]
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0
To describe the safety profile of T-DXd.
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Timepoint [19]
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Cycle 1 (15 days ± 2 days) Day 1 until safety F/U (40+7 days after last dose) (Approximately 2.5 Years)
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Secondary outcome [20]
0
0
Number of Participants with Investigator-assessed ILD/Pneumonitis or Rate of Investigator-assessed ILD/Pneumonitis
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Assessment method [20]
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To describe the safety profile of T-DXd.
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Timepoint [20]
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Cycle 1 (15 days ± 2 days) Day 1 until C4 (15 days ± 2 days) Day 1 and thereafter subsequent cycles until PD (Approximately 2.5 Years)
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Secondary outcome [21]
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Number of Participants with Adverse Events with BM at Baseline
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Assessment method [21]
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To describe the safety profile of T-DXd.
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Timepoint [21]
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Cycle 1 (15 days ± 2 days) Day 1 until safety F/U (40+7 days after last dose) (Approximately 2.5 Years)
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Eligibility
Key inclusion criteria
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
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/02/2024
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Sample size
Target
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Accrual to date
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Final
506
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
Research Site - Adelaide
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Recruitment hospital [2]
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Research Site - Auchenflower
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Recruitment hospital [3]
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Research Site - Clayton
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Recruitment hospital [4]
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Research Site - St Leonards
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Recruitment hospital [5]
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Research Site - Subiaco
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment postcode(s) [5]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Massachusetts
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Country [2]
0
0
United States of America
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State/province [2]
0
0
North Carolina
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Country [3]
0
0
Belgium
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State/province [3]
0
0
Anderlecht
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Country [4]
0
0
Canada
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State/province [4]
0
0
British Columbia
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Country [5]
0
0
Canada
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State/province [5]
0
0
Ontario
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Country [6]
0
0
Denmark
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State/province [6]
0
0
Copenhagen
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Country [7]
0
0
Denmark
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State/province [7]
0
0
Herlev
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Country [8]
0
0
Denmark
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State/province [8]
0
0
Odense C
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Country [9]
0
0
Finland
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State/province [9]
0
0
Helsinki
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Country [10]
0
0
Finland
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State/province [10]
0
0
Tampere
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Country [11]
0
0
Finland
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State/province [11]
0
0
Turku
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Country [12]
0
0
Germany
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State/province [12]
0
0
Berlin
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Country [13]
0
0
Germany
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State/province [13]
0
0
Dresden
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Country [14]
0
0
Germany
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State/province [14]
0
0
Erlangen
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Country [15]
0
0
Germany
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State/province [15]
0
0
Essen
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Country [16]
0
0
Germany
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State/province [16]
0
0
Frankfurt
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Country [17]
0
0
Germany
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State/province [17]
0
0
Hamburg
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Country [18]
0
0
Germany
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State/province [18]
0
0
Hannover
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Country [19]
0
0
Germany
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State/province [19]
0
0
Kiel
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Country [20]
0
0
Germany
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State/province [20]
0
0
Mannheim
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Country [21]
0
0
Germany
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State/province [21]
0
0
München
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0
0
Germany
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State/province [22]
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0
Münster
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0
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Germany
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State/province [23]
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0
Tübingen
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Country [24]
0
0
Ireland
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State/province [24]
0
0
Cork
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Country [25]
0
0
Ireland
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State/province [25]
0
0
Dublin
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Country [26]
0
0
Italy
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State/province [26]
0
0
Ancona
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Country [27]
0
0
Italy
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State/province [27]
0
0
Bergamo
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Country [28]
0
0
Italy
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State/province [28]
0
0
Catania
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Country [29]
0
0
Italy
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State/province [29]
0
0
Milano
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Country [30]
0
0
Italy
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State/province [30]
0
0
Napoli
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Country [31]
0
0
Italy
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State/province [31]
0
0
Padova
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Country [32]
0
0
Italy
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State/province [32]
0
0
Prato
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Country [33]
0
0
Japan
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State/province [33]
0
0
Isehara
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Country [34]
0
0
Japan
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State/province [34]
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0
Kawasaki-shi
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0
0
Japan
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State/province [35]
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0
Sapporo-shi
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0
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Japan
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State/province [36]
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0
Shinagawa-ku
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0
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Japan
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State/province [37]
0
0
Yokohama-shi
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Country [38]
0
0
Netherlands
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State/province [38]
0
0
Den Haag
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Country [39]
0
0
Netherlands
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State/province [39]
0
0
Maastricht
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Country [40]
0
0
Norway
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State/province [40]
0
0
Bergen
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Country [41]
0
0
Norway
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State/province [41]
0
0
Oslo
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Country [42]
0
0
Poland
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State/province [42]
0
0
Gdansk
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Country [43]
0
0
Poland
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State/province [43]
0
0
Kraków
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Country [44]
0
0
Poland
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State/province [44]
0
0
Opole
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Country [45]
0
0
Poland
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State/province [45]
0
0
Warszawa
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Country [46]
0
0
Portugal
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State/province [46]
0
0
Lisboa
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Country [47]
0
0
Portugal
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State/province [47]
0
0
Porto
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Country [48]
0
0
Spain
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State/province [48]
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Barcelona
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Spain
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Bilbao (Vizcaya)
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Spain
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Granada
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Santiago De Compostela-Coruña
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Spain
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Sevilla
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Spain
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Valencia
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Country [57]
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Sweden
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Göteborg
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Sweden
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Lund
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Sweden
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Uppsala
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Switzerland
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Basel
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Switzerland
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Bellinzona
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Country [62]
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Switzerland
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Lausanne
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Switzerland
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Luzern
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Country [64]
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United Kingdom
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Edinburgh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Daiichi Sankyo
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04739761
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Nadia Harbeck, MD, PhD
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Address
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Head, Breast Center, Ludwig-Maximilians-University of Munich Department of Obstetrics and Gynecology Marchioninistr. 15, 81377 Munich, Germany
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04739761
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