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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04622319




Registration number
NCT04622319
Ethics application status
Date submitted
2/11/2020
Date registered
9/11/2020

Titles & IDs
Public title
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
Scientific title
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)
Secondary ID [1] 0 0
2020-003982-20
Secondary ID [2] 0 0
DS8201-A-U305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2-Positive Primary Breast Cancer 0 0
Residual Invasive 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 - DS-8201a
Treatment: Drugs - T-DM1

Experimental: Trastuzumab deruxtecan (T-DXd) - Participants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.

Active comparator: Trastuzumab ematansine (T-DM1) - Participants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.


Treatment: Drugs: DS-8201a
Administered initially as an intravenous (IV) infusion at a dose of 5.4 mg/kg on Day 1 of each 21-day cycle

Treatment: Drugs: T-DM1
Administered initially as an intravenous (IV) infusion at a dose of 3.6 mg/kg on Day 1 of each 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
Timepoint [1] 0 0
Randomization to date of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first), up to approximately 57 months postdose
Secondary outcome [1] 0 0
Disease-free Survival (DFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
Timepoint [1] 0 0
Randomization to date of the first occurrence of an IDFS event including second primary non-breast cancer event or contralateral or ipsilateral ductal carcinoma in situ (whichever occurs first), up to approximately 81 months postdose
Secondary outcome [2] 0 0
Overall Survival (OS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
Timepoint [2] 0 0
Randomization to date of death from any cause, up to approximately 81 months postdose
Secondary outcome [3] 0 0
Distant Recurrence-free Interval (DRFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
Timepoint [3] 0 0
Randomization to date of distant recurrence, up to approximately 81 months postdose
Secondary outcome [4] 0 0
Brain Metastases-free Interval (BMFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
Timepoint [4] 0 0
Randomization to date of brain metastasis, up to approximately 81 months postdose
Secondary outcome [5] 0 0
Percentage of Treatment-emergent Adverse Events in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
Timepoint [5] 0 0
Baseline up to approximately 81 months postdose
Secondary outcome [6] 0 0
Serum Concentrations of Trastuzumab Deruxtecan (T-DXd), total anti-HER2 antibody, and Active Metabolite MAAA-1181a
Timepoint [6] 0 0
Pre-dose on Day 1 of Cycles 1, 4 and 10 and within 15 minutes post-dose on Day 1 of Cycles 1 and 4 (each cycle is 21 days)
Secondary outcome [7] 0 0
Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd)
Timepoint [7] 0 0
Baseline up to approximately 81 months postdose

Eligibility
Key inclusion criteria
Key

* Adults =18 years old (local regulatory requirements will apply if the legal age of consent for study participation is >18 years old).
* Pathologically documented HER2-positive breast cancer (BC):

* HER2-positive expression defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) confirmed prior to study randomization.
* Histologically confirmed invasive breast carcinoma.
* Clinical stage at disease presentation: T1-4, N0-3, M0; patients presenting with T1N0 tumors are not eligible.
* Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting one of the following high-risk criteria:

* Inoperable breast cancer at presentation (prior to neoadjuvant therapy), defined as clinical stages T4, N0-3, M0 or T1-3, N2-3, M0.
* Operable at presentation, defined as clinical stages T1-3,N0-1,M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy.
* Completion of neoadjuvant systemic therapy, including taxane-based chemotherapy and HER2-directed treatment prior to surgery.

* Systemic therapy must consist of at least 6 cycles of neoadjuvant therapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab (± pertuzumab) and at least 9 weeks of taxane-based chemotherapy to be completed prior to surgery. Patients may have received an anthracycline as part of neoadjuvant therapy in addition to taxane chemotherapy.
* Adequate excision as confirmed per medical records: surgical removal of all clinically evident disease in the breast and axillary lymph nodes.
* An interval of no more than 12 weeks between the date of last surgery and the date of randomization.
* Known hormone receptor (HR) status, per local laboratory assessment, as defined by ASCO-CAP guidelines (=1%): HR positive status defined by either positive estrogen receptor (ER) and/or positive progesterone receptor (PR).

status. HR-negative status defined by both known negative ER and known negative PR.

* Left ventricular ejection fraction (LVEF) =50% within 28 days prior to randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
* Has adequate organ function within 14 days before randomization.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Stage IV (metastatic) BC.
* History of any prior (ipsi- or contralateral) breast cancer except lobular carcinoma in situ (LCIS).
* Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery.
* Prior treatment with T-DXd, T-DM1 or other anti-HER2 antibody-drug conjugate (ADC) or prior enrollment in a clinical study of T-DXd (regardless of treatment arm)
* History of exposure to the following cumulative doses of anthracyclines:

* Doxorubicin > 240 mg/m^2
* Epirubicin or Liposomal Doxorubicin-Hydrochloride > 480 mg/m^2
* For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m^2
* History of other malignancy within the last 5 years except for appropriately treated CIS of the cervix, nonmelanoma skin carcinoma, Stage I melanoma skin carcinoma, Stage I uterine cancer, or other appropriately treated non-breast malignancies with an outcome similar to those mentioned above.
* History of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids and/or has ILD/pneumonitis noted on computed tomography (CT) scan of the chest at Screening (asymptomatic interstitial changes confined to recent radiation therapy fields are not excluded).
* Known pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months prior to randomization, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease).
* Any autoimmune, connective tissue or inflammatory disorders (eg, Rheumatoid arthritis, Sjogren's, sarcoidosis, etc) where there is documented or a suspicion of pulmonary involvement or pneumonectomy at the time of screening.
* Medical history of myocardial infarction (MI) within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer 28 days prior to randomization.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Chris O Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Austin Hospital- Olivia Newto-John Cancer and Wellness Centre - Heidelberg
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
Breast Cancer Research Centre - WA - Nedlands
Recruitment hospital [7] 0 0
Genesis Care Northern Cancer - Saint Leonards
Recruitment hospital [8] 0 0
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC) - Subiaco
Recruitment hospital [9] 0 0
Southern Medical Day Care Centre - Wollongong
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5000 - Adelaide
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2050 - Camperdown
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3168 - Clayton
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3804 - Heidelberg
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3000 - Melbourne
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6009 - Nedlands
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2065 - Saint Leonards
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2050 - Subiaco
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2500 - Wollongong
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State/province [182] 0 0
Isehara City
Country [183] 0 0
Japan
State/province [183] 0 0
Kagoshima City
Country [184] 0 0
Japan
State/province [184] 0 0
Kashiwa City
Country [185] 0 0
Japan
State/province [185] 0 0
Koto-Ku
Country [186] 0 0
Japan
State/province [186] 0 0
Kyoto
Country [187] 0 0
Japan
State/province [187] 0 0
Matsuyama City
Country [188] 0 0
Japan
State/province [188] 0 0
Nagoya City
Country [189] 0 0
Japan
State/province [189] 0 0
Niigata City
Country [190] 0 0
Japan
State/province [190] 0 0
Nishinomiya City
Country [191] 0 0
Japan
State/province [191] 0 0
Okayama City
Country [192] 0 0
Japan
State/province [192] 0 0
Osaka City
Country [193] 0 0
Japan
State/province [193] 0 0
Saitama
Country [194] 0 0
Japan
State/province [194] 0 0
Sapporo City
Country [195] 0 0
Japan
State/province [195] 0 0
Sayama City
Country [196] 0 0
Japan
State/province [196] 0 0
Sendai City
Country [197] 0 0
Japan
State/province [197] 0 0
Shinagawa-Ku
Country [198] 0 0
Japan
State/province [198] 0 0
Shinjuku-Ku
Country [199] 0 0
Japan
State/province [199] 0 0
Shizuoka
Country [200] 0 0
Japan
State/province [200] 0 0
Yokohama City
Country [201] 0 0
Korea, Republic of
State/province [201] 0 0
Daegu
Country [202] 0 0
Korea, Republic of
State/province [202] 0 0
Gyeonggi-do
Country [203] 0 0
Korea, Republic of
State/province [203] 0 0
Incheon
Country [204] 0 0
Korea, Republic of
State/province [204] 0 0
Irwon-dong
Country [205] 0 0
Korea, Republic of
State/province [205] 0 0
Seoul
Country [206] 0 0
Korea, Republic of
State/province [206] 0 0
Songpa-gu
Country [207] 0 0
Korea, Republic of
State/province [207] 0 0
Yongsan
Country [208] 0 0
Mexico
State/province [208] 0 0
Coahuila
Country [209] 0 0
Mexico
State/province [209] 0 0
JAL
Country [210] 0 0
Mexico
State/province [210] 0 0
Nuevo Leon
Country [211] 0 0
Netherlands
State/province [211] 0 0
Noord-Holland
Country [212] 0 0
Netherlands
State/province [212] 0 0
Breda
Country [213] 0 0
Netherlands
State/province [213] 0 0
Rotterdam
Country [214] 0 0
Peru
State/province [214] 0 0
Lima
Country [215] 0 0
Peru
State/province [215] 0 0
Trujillo
Country [216] 0 0
Poland
State/province [216] 0 0
Opolskie
Country [217] 0 0
Poland
State/province [217] 0 0
Pomorskie
Country [218] 0 0
Poland
State/province [218] 0 0
Wielkopolskie
Country [219] 0 0
Poland
State/province [219] 0 0
Warsaw
Country [220] 0 0
Poland
State/province [220] 0 0
Lódz
Country [221] 0 0
Portugal
State/province [221] 0 0
Guimarães
Country [222] 0 0
Portugal
State/province [222] 0 0
Lisboa
Country [223] 0 0
Portugal
State/province [223] 0 0
Loures
Country [224] 0 0
Portugal
State/province [224] 0 0
Matosinhos
Country [225] 0 0
Portugal
State/province [225] 0 0
Porto
Country [226] 0 0
Portugal
State/province [226] 0 0
Vila Nova De Gaia
Country [227] 0 0
Romania
State/province [227] 0 0
Cluj
Country [228] 0 0
Romania
State/province [228] 0 0
Dolj
Country [229] 0 0
Romania
State/province [229] 0 0
Bucharest
Country [230] 0 0
Russian Federation
State/province [230] 0 0
Arkhangel'sk
Country [231] 0 0
Russian Federation
State/province [231] 0 0
Sochi
Country [232] 0 0
Singapore
State/province [232] 0 0
Singapore
Country [233] 0 0
Spain
State/province [233] 0 0
Bizkaia
Country [234] 0 0
Spain
State/province [234] 0 0
Murcia
Country [235] 0 0
Spain
State/province [235] 0 0
Tarragona
Country [236] 0 0
Spain
State/province [236] 0 0
Alcorcón
Country [237] 0 0
Spain
State/province [237] 0 0
Alicante
Country [238] 0 0
Spain
State/province [238] 0 0
Badajoz
Country [239] 0 0
Spain
State/province [239] 0 0
Barcelona
Country [240] 0 0
Spain
State/province [240] 0 0
Castellón
Country [241] 0 0
Spain
State/province [241] 0 0
Coruña
Country [242] 0 0
Spain
State/province [242] 0 0
Cáceres
Country [243] 0 0
Spain
State/province [243] 0 0
Girona
Country [244] 0 0
Spain
State/province [244] 0 0
Granada
Country [245] 0 0
Spain
State/province [245] 0 0
Jaén
Country [246] 0 0
Spain
State/province [246] 0 0
León
Country [247] 0 0
Spain
State/province [247] 0 0
Lleida
Country [248] 0 0
Spain
State/province [248] 0 0
Madrid
Country [249] 0 0
Spain
State/province [249] 0 0
Málaga
Country [250] 0 0
Spain
State/province [250] 0 0
Móstoles
Country [251] 0 0
Spain
State/province [251] 0 0
Navarro
Country [252] 0 0
Spain
State/province [252] 0 0
Palma De Mallorca
Country [253] 0 0
Spain
State/province [253] 0 0
San Cristobal de la Laguna
Country [254] 0 0
Spain
State/province [254] 0 0
Sant Cugat Del Vallès
Country [255] 0 0
Spain
State/province [255] 0 0
Santiago De Compostela
Country [256] 0 0
Spain
State/province [256] 0 0
Sevilla
Country [257] 0 0
Spain
State/province [257] 0 0
Valencia
Country [258] 0 0
Spain
State/province [258] 0 0
Zaragoza
Country [259] 0 0
Taiwan
State/province [259] 0 0
Yanchao District
Country [260] 0 0
Taiwan
State/province [260] 0 0
Beitou
Country [261] 0 0
Taiwan
State/province [261] 0 0
Chang Hua
Country [262] 0 0
Taiwan
State/province [262] 0 0
Kaohsiung
Country [263] 0 0
Taiwan
State/province [263] 0 0
Taichung
Country [264] 0 0
Taiwan
State/province [264] 0 0
Tainan
Country [265] 0 0
Taiwan
State/province [265] 0 0
Taipei
Country [266] 0 0
Turkey
State/province [266] 0 0
Iç Anadolu
Country [267] 0 0
Turkey
State/province [267] 0 0
Edirne
Country [268] 0 0
Turkey
State/province [268] 0 0
Istanbul
Country [269] 0 0
Turkey
State/province [269] 0 0
Izmir
Country [270] 0 0
United Kingdom
State/province [270] 0 0
Cambridgeshire
Country [271] 0 0
United Kingdom
State/province [271] 0 0
Kent
Country [272] 0 0
United Kingdom
State/province [272] 0 0
Lancashire
Country [273] 0 0
United Kingdom
State/province [273] 0 0
Merseyside
Country [274] 0 0
United Kingdom
State/province [274] 0 0
Nottinghamshire
Country [275] 0 0
United Kingdom
State/province [275] 0 0
Somerset
Country [276] 0 0
United Kingdom
State/province [276] 0 0
West Yorkshire
Country [277] 0 0
United Kingdom
State/province [277] 0 0
Bristol
Country [278] 0 0
United Kingdom
State/province [278] 0 0
Colchester
Country [279] 0 0
United Kingdom
State/province [279] 0 0
Exeter
Country [280] 0 0
United Kingdom
State/province [280] 0 0
Glasgow
Country [281] 0 0
United Kingdom
State/province [281] 0 0
London
Country [282] 0 0
United Kingdom
State/province [282] 0 0
Oxford
Country [283] 0 0
United Kingdom
State/province [283] 0 0
Peterborough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
NSABP Foundation Inc
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
German Breast Group
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Spanish Breast Cancer Research Group (SOLTI)
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


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/NCT04622319