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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04538742
Registration number
NCT04538742
Ethics application status
Date submitted
31/08/2020
Date registered
4/09/2020
Titles & IDs
Public title
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
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Scientific title
A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)
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Secondary ID [1]
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2019-004531-22
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Secondary ID [2]
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D967JC00001
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Universal Trial Number (UTN)
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Trial acronym
DB-07
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab deruxtecan
Treatment: Drugs - Durvalumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Tucatinib
Experimental: Module 1- T-DXd and Durvalumab - T-DXd and Durvalumab
Experimental: Module 2- T-DXd and Pertuzumab - T-DXd and Pertuzumab
Experimental: Module 3- T-DXd and Paclitaxel - T-DXd and Paclitaxel (Arm not initiated in Part 2)
Experimental: Module 4- T-DXd and Durvalumab and Paclitaxel - T-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2)
Experimental: Module 0- T-DXd - T-DXd
Experimental: Module 5 - T-DXd and Tucatanib - T-DXd and tucatinib (Arm not initiated in Part 2)
Experimental: Module 6 - T-DXd and Tucatinib - T-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated)
Experimental: Module 7 - T-DXd - T-DXd monotherapy in patients with active brain metastases (Part 2 Only)
Treatment: Drugs: Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Treatment: Drugs: Durvalumab
Durvalumab: administered as an IV infusion
Treatment: Drugs: Paclitaxel
Paclitaxel: administered as an IV infusion
Treatment: Drugs: Pertuzumab
Pertuzumab: administered as an IV infusion
Treatment: Drugs: Tucatinib
Tucatinib administered orally (tablet) twice daily
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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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Occurrence of adverse events (AEs)- Part 1
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Assessment method [1]
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Occurrence of AEs in Part 1 graded according to NCI CTCAE v5.0
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Timepoint [1]
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Up to follow-up period, approximately 53 months
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Primary outcome [2]
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Occurrence of serious adverse events (SAEs)- Part 1
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Assessment method [2]
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Occurrence of SAEs in Part 1 graded according to NCI CTCAE v5.0
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Timepoint [2]
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Up to follow-up period, approximately 53 months
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Primary outcome [3]
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Occurrence of adverse events (AEs)- Part 2
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Assessment method [3]
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Occurrence of AEs in Part 2 graded according to NCI CTCAE v5.0
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Timepoint [3]
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Up to follow-up period, approximately 53 months
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Primary outcome [4]
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Occurrence of serious adverse events (SAEs)- Part 2
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Assessment method [4]
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Occurrence of SAEs in Part 2 graded according to NCI CTCAE v5.0
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Timepoint [4]
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Up to follow-up period, approximately 53 months
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Secondary outcome [1]
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Objective Response Rate (ORR)- Part 1 and Part 2
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Assessment method [1]
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ORR is defined as the proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
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Timepoint [1]
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Until progression, assessed up to approximately 53 months
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Secondary outcome [2]
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Progression Free Survival (PFS)- Part 1 and Part 2
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Assessment method [2]
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PFS is defined as time from the date of randomization until the date of progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
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Timepoint [2]
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Until progression, assessed up to approximately 53 months
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Secondary outcome [3]
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Progression Free Survival 2 (PFS2)- Part 2
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Assessment method [3]
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PFS2 is defined as time from the date of randomisation until the date of progression on next line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy) or death; second progression will be defined according to local standard clinical practice.
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Timepoint [3]
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Assessed up to approximately 53 months
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Secondary outcome [4]
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Duration of Response (DoR)- Part 2
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Assessment method [4]
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DoR is defined as time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
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Timepoint [4]
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Until progression, assessed up to approximately 53 months
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Secondary outcome [5]
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Overall Survival (OS)- Part 2
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Assessment method [5]
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OS is defined as time from the date of randomisation until the date of death due to any cause.
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Timepoint [5]
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Until death, assessed up to approximately 53 months
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Secondary outcome [6]
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Serum Concentration of Trastuzumab Deruxtecan (T-DXd)
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Assessment method [6]
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Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration
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Timepoint [6]
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While on study drug up to study completion, approximately 53 months
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Secondary outcome [7]
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Serum Concentration of Durvalumab
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Assessment method [7]
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Determination of durvalumab concentration in serum at different time points after administration
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Timepoint [7]
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While on study drug up to study completion, approximately 53 months
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Secondary outcome [8]
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Serum Concentration of Pertuzumab
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Assessment method [8]
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Determination of pertuzumab concentration in serum at different time points after administration
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Timepoint [8]
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While on study drug up to study completion, approximately 53 months
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Secondary outcome [9]
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Plasma Concentration of Paclitaxel
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Assessment method [9]
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Determination of paclitaxel concentration in plasma at different time points after administration
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Timepoint [9]
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While on study drug up to study completion, approximately 53 months
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Secondary outcome [10]
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Plasma Concentration of Tucatinib
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Assessment method [10]
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Determination of tucatinib concentration in plasma at different time points after administration
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Timepoint [10]
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While on study drug up to study completion, approximately 53 months
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Secondary outcome [11]
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Immunogenicity of trastuzumab deruxtecan
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Assessment method [11]
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Percentage of patients who develop ADA for trastuzumab deruxtecan
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Timepoint [11]
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Up to follow-up period, approximately 53 months
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Secondary outcome [12]
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Immunogenicity of Durvalumab
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Assessment method [12]
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Percentage of patients who develop ADA for durvalumab
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Timepoint [12]
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Up to follow-up period, approximately 53 months
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Secondary outcome [13]
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Immunogenicity of Pertuzumab
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Assessment method [13]
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Percentage of patients who develop ADA for pertuzumab
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Timepoint [13]
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Up to follow-up period, approximately 53 months
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Eligibility
Key inclusion criteria
Key
* Patients must be at least 18 years of age
* Pathologically documented breast cancer that:
1. Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic
2. HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment. The local HER2 result must be from a tumour sample obtained in the metastatic setting.
3. Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
* Patient must have adequate tumor sample from the metastatic setting for biomarker assessment
* ECOG Performance Status of 0 or 1
* Part 1
1. Disease progression on or after the last systemic therapy prior to starting study treatment
2. At least 1 prior treatment line in metastatic setting required.
* Part 2 (Modules 0 - 5)
a) No prior lines of therapy for advanced/MBC allowed
* Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed
CNS Inclusion
* Modules 0 - 5 Patients must have no brain metastases or stable brain metastases.
* Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy
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Minimum age
18
Years
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Maximum age
No limit
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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
* Uncontrolled or significant cardiovascular disease
* Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Lung-specific intercurrent clinically significant illnesses
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
* Spinal cord compression or a history of leptomeningeal carcinomatosis
* Prior treatment with immune checkpoint inhibitors
* Prior treatment with an ADC containing a topoisomerase I inhibitor
* Prior treatment with tucatinib
CNS Exclusion
* Modules 0 - 5: Has untreated brain metastasis
* Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg dexamethasone or any brain lesion thought to require immediate local therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
28/12/2020
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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
31/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
245
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Florida
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United States of America
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State/province [2]
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New York
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0
United States of America
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Ohio
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0
United States of America
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State/province [4]
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Tennessee
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Country [5]
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0
United States of America
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State/province [5]
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Texas
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United States of America
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State/province [6]
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Virginia
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Brazil
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State/province [7]
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Barretos
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Brazil
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Belo Horizonte
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Brazil
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Natal
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Brazil
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Sorocaba
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Canada
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Quebec
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Canada
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Toronto
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France
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Villejuif Cedex
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Germany
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München
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Germany
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Würzburg
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India
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Delhi
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India
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Gurgaon
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India
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Madurai
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India
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Mumbai
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Bologna
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Rome
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Korea, Republic of
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Busan-si
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Seoul
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Bydgoszcz
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Koszalin
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Lublin
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Lódz
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Russian Federation
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Moscow
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Russian Federation
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Barcelona
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Spain
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L'Hospitalet de Llobregat
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Spain
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Madrid
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Sevilla
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Taiwan
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Hualien
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Tainan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Turkey
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Ankara
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Edirne
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Istanbul
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Izmir
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United Kingdom
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Buckhurst Hill
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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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Other
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Name [1]
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Daiichi Sankyo Company, Limited
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Ethics approval
Ethics application status
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Summary
Brief summary
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer
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Trial website
https://clinicaltrials.gov/study/NCT04538742
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request 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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified 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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04538742