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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05950945




Registration number
NCT05950945
Ethics application status
Date submitted
22/05/2023
Date registered
18/07/2023

Titles & IDs
Public title
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Scientific title
A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)
Secondary ID [1] 0 0
2023-505616-38-00
Secondary ID [2] 0 0
DS8201-0001-CIS-MA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Experimental: Cohort 1: HR-negative, HER2-low - Participants with HR-negative HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.

Experimental: Cohort 2: HR-negative, HER2 IHC 0 - Participants with HR-negative HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.

Experimental: Cohort 3: HR-positive, HER2-low - Participants with HR-positive HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.

Participants must also have recurrent disease \<2 years from the initiation of adjuvant ET or have disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor or have disease progression within the first 12 months of CDK4/6 in the first line metastatic setting.

Experimental: Cohort 4: HR-positive, HER2 IHC 0 - Participants with HR-positive HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.


Treatment: Drugs: Trastuzumab Deruxtecan
Intravenous administration, 5.4 mg/kg on Day 1 of each 21-day cycle until radiographic disease progression as assessed by the investigator, unacceptable toxicity, other discontinuation criteria are met, or 2 years after first dose of study drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT)
Timepoint [1] 0 0
Until subsequent therapy or death, assessed up to 24 months
Secondary outcome [1] 0 0
Real-World Progression Free Survival (PFS)
Timepoint [1] 0 0
Until progression or death, assessed up to 24 months
Secondary outcome [2] 0 0
Time From Start of T-DXd to Discontinuation of T-DXd or Death (TTD)
Timepoint [2] 0 0
Until treatment discontinuation or death, up to 24 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Until progression, assessed up to 24 months
Secondary outcome [4] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [4] 0 0
Up to follow up period, up to 24 months
Secondary outcome [5] 0 0
Mean Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC-QLQ)-C30 Score
Timepoint [5] 0 0
Assessed up to 24 months
Secondary outcome [6] 0 0
Mean Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC-QLQ)-BR45 Score
Timepoint [6] 0 0
Assessed up to 24 months
Secondary outcome [7] 0 0
Time to First and Definitive Deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC-QLQ) Scales
Timepoint [7] 0 0
Assessed up to 24 months
Secondary outcome [8] 0 0
Mean Change from Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L)
Timepoint [8] 0 0
Assessed up to 24 months
Secondary outcome [9] 0 0
Mean Change From Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Index Score
Timepoint [9] 0 0
Assessed up to 24 months
Secondary outcome [10] 0 0
Mean Change From Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)
Timepoint [10] 0 0
Assessed up to 24 months
Secondary outcome [11] 0 0
Time to First and Definitive Deterioration in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)
Timepoint [11] 0 0
Assessed up to 24 months
Secondary outcome [12] 0 0
Patient's Global Impression of Change (PGI-C) Response
Timepoint [12] 0 0
Assessed up to 24 months
Secondary outcome [13] 0 0
Patient's Global Impression of Severity (PGI-S) Response
Timepoint [13] 0 0
Assessed up to 24 months
Secondary outcome [14] 0 0
Patient's Global Impression of Treatment Tolerability (PGI-TT) Response
Timepoint [14] 0 0
Assessed up to 24 months

Eligibility
Key inclusion criteria
* Sign and date the main informed consent form
* Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion.
* Pathologically documented Breast Cancer (BC) tumor

* Is unresectable and/or metastatic.
* Is hormone receptor-negative or hormone receptor-positive.

* Must include percentage of positively stained cells to characterize if hormone receptor-positive or -negative.
* Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above.
* Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines).
* Was never previously treated with anti-HER2 therapy in the metastatic setting.
* Has had at least one and up to two prior lines of therapy in the metastatic setting.

* In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3):

* Has recurrent disease <2 years from the initiation of adjuvant ET OR
* Has disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor OR
* Has disease progression within the first 12 months of CDK4/6 in the first line metastatic setting
* Presence of at least one measurable lesion based on computed tomography or magnetic resonance imaging.
* Participants with brain metastases are allowed in the study. The brain lesion(s) should be small (<2 cm), untreated, asymptomatic, not requiring urgent medical intervention, and are asymptomatic and clinically stable.
* Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
* Has a minimum life expectancy of 12 weeks at Screening.
* Has a left ventricular ejection fraction =50% within 28 days before enrollment.
* Has adequate organ and bone marrow function within 28 days before enrollment.
* Has adequate treatment washout period before enrollment.
* Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with an antibody drug conjugate (ADC).
* Uncontrolled or significant cardiovascular disease.
* Has a corrected QT interval prolongation.
* Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
* Has spinal cord compression or clinically active central nervous system metastases.
* Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral BC.
* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
* Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
* Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
* Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
* Has history of receiving a live, attenuated vaccine (messenger RNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug.
* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade =1 or baseline.
* Is pregnant or breastfeeding or planning to become pregnant.
* Lung-specific intercurrent clinically significant illnesses.
* Any autoimmune, connective tissue, or inflammatory disorders.
* Prior complete pneumonectomy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
30/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Mater Hospital Sydney - North Sydney
Recruitment hospital [2] 0 0
Monash Medical Centre Moorabbin - East Bentleigh
Recruitment postcode(s) [1] 0 0
2065 - North Sydney
Recruitment postcode(s) [2] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
Belgium
State/province [4] 0 0
Anderlecht
Country [5] 0 0
Belgium
State/province [5] 0 0
Antwerpen
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Liege
Country [9] 0 0
Belgium
State/province [9] 0 0
Wilrijk
Country [10] 0 0
Brazil
State/province [10] 0 0
Brasilia
Country [11] 0 0
Brazil
State/province [11] 0 0
Curitiba
Country [12] 0 0
Brazil
State/province [12] 0 0
Florianopolis
Country [13] 0 0
Brazil
State/province [13] 0 0
Ijuí
Country [14] 0 0
Brazil
State/province [14] 0 0
Jaú
Country [15] 0 0
Brazil
State/province [15] 0 0
Londrina
Country [16] 0 0
Brazil
State/province [16] 0 0
Riberão Preto
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio Grande Do Sul
Country [18] 0 0
Brazil
State/province [18] 0 0
Salvador
Country [19] 0 0
Brazil
State/province [19] 0 0
Santa Catarina
Country [20] 0 0
Brazil
State/province [20] 0 0
Santo André
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Jose do Rio Preto
Country [22] 0 0
Brazil
State/province [22] 0 0
São Paulo
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Fujian
Country [25] 0 0
China
State/province [25] 0 0
Guangzhou
Country [26] 0 0
China
State/province [26] 0 0
Hangzhou
Country [27] 0 0
China
State/province [27] 0 0
Hefei
Country [28] 0 0
China
State/province [28] 0 0
Jinan
Country [29] 0 0
China
State/province [29] 0 0
Kunming
Country [30] 0 0
China
State/province [30] 0 0
Nanchang
Country [31] 0 0
China
State/province [31] 0 0
Qingdao
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Zhengzhou
Country [34] 0 0
Ireland
State/province [34] 0 0
Cork
Country [35] 0 0
Ireland
State/province [35] 0 0
Dublin
Country [36] 0 0
Ireland
State/province [36] 0 0
Galway
Country [37] 0 0
Italy
State/province [37] 0 0
Bari
Country [38] 0 0
Italy
State/province [38] 0 0
Bologna
Country [39] 0 0
Italy
State/province [39] 0 0
Genova
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Misterbianco
Country [42] 0 0
Italy
State/province [42] 0 0
Naples
Country [43] 0 0
Italy
State/province [43] 0 0
Padova
Country [44] 0 0
Italy
State/province [44] 0 0
Prato
Country [45] 0 0
Italy
State/province [45] 0 0
Rome
Country [46] 0 0
Italy
State/province [46] 0 0
Trento
Country [47] 0 0
Netherlands
State/province [47] 0 0
Amsterdam
Country [48] 0 0
Netherlands
State/province [48] 0 0
Breda
Country [49] 0 0
Netherlands
State/province [49] 0 0
Den Haag
Country [50] 0 0
Netherlands
State/province [50] 0 0
Leeuwarden
Country [51] 0 0
Netherlands
State/province [51] 0 0
Leiden
Country [52] 0 0
Netherlands
State/province [52] 0 0
Maastricht
Country [53] 0 0
Netherlands
State/province [53] 0 0
Tilburg
Country [54] 0 0
Netherlands
State/province [54] 0 0
Uden
Country [55] 0 0
Portugal
State/province [55] 0 0
Braga
Country [56] 0 0
Portugal
State/province [56] 0 0
Lisboa
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Granada
Country [59] 0 0
Spain
State/province [59] 0 0
Las Palmas de Gran Canaria
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Majadahonda
Country [62] 0 0
Spain
State/province [62] 0 0
Murcia
Country [63] 0 0
Spain
State/province [63] 0 0
Pamplona
Country [64] 0 0
Spain
State/province [64] 0 0
San Sebastian
Country [65] 0 0
Spain
State/province [65] 0 0
Santiago de Compostela
Country [66] 0 0
Spain
State/province [66] 0 0
Sevilla
Country [67] 0 0
Spain
State/province [67] 0 0
Valencia

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

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
(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
908-992-6400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT05950945