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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04494425




Registration number
NCT04494425
Ethics application status
Date submitted
20/07/2020
Date registered
31/07/2020
Date last updated
19/04/2021

Titles & IDs
Public title
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scientific title
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Secondary ID [1] 0 0
D9670C00001
Universal Trial Number (UTN)
Trial acronym
DB-06
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab deruxtecan
Treatment: Drugs - Capecitabine
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-Paclitaxel

Experimental: Trastuzumab deruxtecan - Trastuzumab deruxtecan (T-DXd; DS-8201a) arm

Active Comparator: Standard of Care - Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm


Treatment: Drugs: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion

Treatment: Drugs: Capecitabine
Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.

Treatment: Drugs: Paclitaxel
Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.

Treatment: Drugs: Nab-Paclitaxel
Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - in HR+, HER2-low populaton - Defined as time from date of randomization until the date of objective radiological disease progression by blinded independent central review (BICR) assessment according to RECIST 1.1 or death.
Timepoint [1] 0 0
Until progression or death, assessed up to approximately 60 months
Secondary outcome [1] 0 0
Overall Survival (OS) - in HR+, HER2-low population - Defined as the time from randomization to death due to any cause
Timepoint [1] 0 0
Until death, assessed up to approximately 60 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+) - PFS by BICR according to RECIST 1.1 in ITT population
Timepoint [2] 0 0
Until progression or death, assessed up to approximately 60 months
Secondary outcome [3] 0 0
Overall Survival - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+) - OS in the ITT population
Timepoint [3] 0 0
Until death, assessed up to approximately 60 months
Secondary outcome [4] 0 0
Objective Response Rate (ORR) in HR+, HER-2 low populaton - ORR defined as the percentage of patients with at least one visit response of complete or partial response (CR or PR) by BICR and Investigator assessment according to RECIST 1.1.
Timepoint [4] 0 0
Until progression, assessed up to approximately 60 months
Secondary outcome [5] 0 0
Duration of response (DoR) - in HR+, HER-2 low populaton - DoR defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by BICR and Investigator assessment according to RECIST 1.1
Timepoint [5] 0 0
Until progression, assessed up to approximately 60 months
Secondary outcome [6] 0 0
Progression Free Survival by Investigator assessment - in the HR+, HER2-low population - PFS using investigator assessments according to RECIST 1.1 in the HER2-low population
Timepoint [6] 0 0
Until progression or death, assessed up to approximately 60 months
Secondary outcome [7] 0 0
Objective Response Rate (ORR) in the ITT population - ORR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population
Timepoint [7] 0 0
Until progression, assessed up to approximately 60 months
Secondary outcome [8] 0 0
Duration of response (DoR) - in the ITT population - DoR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population
Timepoint [8] 0 0
Until progression, assessed up to approximately 60 months
Secondary outcome [9] 0 0
PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population - PFS2 defined as time from randomisation to second progression or death. TFST defined as a time elapsed from randomization to first subsequent therapy or death. TSST defined as a time elapsed from randomization to second subsequent therapy or death.
Timepoint [9] 0 0
Assessed up to approximately 60 months
Secondary outcome [10] 0 0
Safety and tolerability of drugs; number of adverse events (AEs) - Number of AEs according to NCI-CTCAE Version 5.0 per each treatment arm
Timepoint [10] 0 0
Up to follow-up period, approximately 60 months
Secondary outcome [11] 0 0
Serum concentration of trastuzumab deruxtecan - Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration
Timepoint [11] 0 0
Up to Cycle 8, approximately Week 24; each cycle is 21 days
Secondary outcome [12] 0 0
Immunogenicity of trastuzumab deruxtecan - Percentage of patients who develop ADA for trastuzumab deruxtecan
Timepoint [12] 0 0
Up to follow-up period, approximately 60 months
Secondary outcome [13] 0 0
Health-related quality of life - EORTC-QLQ-C30 - Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Timepoint [13] 0 0
Assessed up to approximately 60 months
Secondary outcome [14] 0 0
Time to deterioration in EORTC-QLQ-C30 scores - Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Timepoint [14] 0 0
Assessed up to approximately 60 months
Secondary outcome [15] 0 0
Health-related quality of life - EORTC QLQ-BR45 - Change from baseline in the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR45) score. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Timepoint [15] 0 0
Assessed up to approximately 60 months

Eligibility
Key inclusion criteria
Key

- Patients must be =18 years of age

- Pathologically documented breast cancer that:

1. is advanced or metastatic

2. has a history of HER2-low or negative expression defined as IHC 2+/ISH- or IHC 1+
(ISH- or untested) or HER2 IHC 0 (ISH- or untested)

3. has HER2-low or HER2 IHC >0 <1+ expression

4. was never previously HER2-positive

5. is documented HR+ disease in the metastatic setting.

- No prior chemotherapy for advanced or metastatic breast cancer.

- Has adequate tumor samples for assessment of HER2 status

- Either disease progression on at least 2 previous lines of endocrine therapy with or
without a targeted therapy in the metastatic setting or disease progression within 24
months of starting adjuvant endocrine therapy and on at least 1 previous line of
endocrine therapy in the metastatic setting

- Has protocol-defined adequate organ and bone marrow function

Key
Minimum age
18 Years
Maximum age
105 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Ineligible for all options in the investigator's choice chemotherapy arm

- Lung-specific intercurrent clinically significant illnesses

- Uncontrolled or significant cardiovascular disease or infection

- Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected
ILD/pneumonitis that cannot be ruled out by imaging at screening

- Patients with spinal cord compression or clinically active central nervous system
metastases

- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless
of treatment arm assignment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Auchenflower
Recruitment hospital [2] 0 0
Research Site - Birtinya
Recruitment hospital [3] 0 0
Research Site - Concord
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Research Site - Darlinghurst
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Research Site - Frankston
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Research Site - Hobart
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Research Site - St Leonards
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Research Site - Waratah
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4066 - Auchenflower
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4575 - Birtinya
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2139 - Concord
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2010 - Darlinghurst
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3065 - Fitzroy
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3199 - Frankston
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7000 - Hobart
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2065 - St Leonards
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2298 - Waratah
Recruitment outside Australia
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Sweden
State/province [182] 0 0
Stockholm
Country [183] 0 0
Sweden
State/province [183] 0 0
Umeå
Country [184] 0 0
Sweden
State/province [184] 0 0
Uppsala
Country [185] 0 0
Sweden
State/province [185] 0 0
Växjö
Country [186] 0 0
Sweden
State/province [186] 0 0
Örebro
Country [187] 0 0
Taiwan
State/province [187] 0 0
Taichung
Country [188] 0 0
Taiwan
State/province [188] 0 0
Tainan
Country [189] 0 0
Taiwan
State/province [189] 0 0
Taipei
Country [190] 0 0
Taiwan
State/province [190] 0 0
Tao-Yuan
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Cambridge
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Cardiff
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Edinburgh
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Guildford
Country [195] 0 0
United Kingdom
State/province [195] 0 0
London
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Manchester
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Northwood
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan
compared with investigator's choice chemotherapy in human epidermal growth factor receptor
(HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has
progressed on endocrine therapy in the metastatic setting.
Trial website
https://clinicaltrials.gov/show/NCT04494425
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04494425