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DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

StatusActive, Not Recruiting
PhasePhase 3
Started2018-08-09
View on ClinicalTrials.gov ↗

Amendment history

2025-10-17
Study Status v42
Completion date2025-11-27→2026-07-30
2025-07-09
Study Identification, Study Status, Eligibility v41
Completion date2025-06-01→2025-11-27
Eligibility criteria+678 characters
Inclusion Criteria: IsMust be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) or Ethics Committee (EC) approved ICF before performance of any study-specific procedures or tests. Adults ≥18 y old. (Please follow local regulatory requirements if the legal age of majorityconsent infor theirstudy countryparticipation is >18 y old.) Has pathologicallyPathologically documented breast cancer that: is unresectable or metastatic. has confirmed HER2-positive expression as determined accord [...] an Pathologists guidelines evaluated at a central laboratory.23 was previously [...] [...]
2024-05-29
2 amendments v39-v40
2 re-verifications since 2024-04-16, no change to tracked fields
2024-04-02
Study Status, Contacts/Locations v38
Study sites164 entries, revised
ClínicaCatarina dePesquisa NeoplasiasClinica Instituto Litoral Ltda.Americas COIICO - Clínicas Oncológicas Integradas Institut de cancérologie de l'ouest, siteSite René Gauducheau Hôpital d'Instruction des Armees Begin* QueenThe Mary HospitalChinese ChineseThe University of Hong Kong The Christie NHS Foundation TrustHospital
2024-01-17
Study Status v37
Completion date2024-04→2025-06-01
Show 36 earlier versions
2023-02-07
Study Status v36
Completion date2023-04→2024-04
2022-04-01
Study Status, Outcome Measures (Results) v35
Results first postednot stated→2022-04-29
2022-03-07
Study Status, Study Design, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v34
Primary completion date2021-06-29→2021-05-21
Start date2018-07-20→2018-08-09
Enrollment targetestimated 500→confirmed 524
InterventionsAdo-trastuzumab emtansine (T-DM1) (Drug), Trastuzumab deruxtecan (DS-8201a) (Drug)→Ado-trastuzumab emtansine (T-DM1) (Drug), Trastuzumab deruxtecan (T-DXd) (Drug)
Secondary endpoints4 entries, revised
Overall survivalSurvival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Percentage of Participants With Objective responseResponse rateRate (ORR) basedBased on BICR and investigator'sInvestigator assessmentAssessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Duration of responseResponse (DoR) basedBased on BICR and investigator'sInvestigator assessmentAssessment in Participants With HER2-Positive, Unresectable and/or Metasta [...] [...]
Primary endpoints1 entry, revised
Progression-freeFree survivalSurvival (PFS) basedBased on blindedBlinded independentIndependent centralCentral reviewReview (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
2022-01-07
Study Status v33
Primary completion dateestimated 2022-02→confirmed 2021-06-29
2020-12-02
Study Status, Contacts/Locations v32
Study sites166→164
2020-09-23
Study Status, Outcome Measures, Eligibility, Contacts/Locations v31
Completion date2022-02→2023-04
Eligibility criteria+228 characters
[...] oid intercourse during and upon completion of the study for at least 4.57 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males) or 7 months after the last dose of T-DM1 Has adequate renal [...] been treated with an anti-HER2 antibody drug conjugate (ADC) in the metastatic setting. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy Has uncontrolled or significant cardiovascular disease Has a [...]
Secondary endpoints5 to 4 entries
Clinical benefit rate (CBR)
Study sitesdetails revised at 1 of 166 sites
2020-07-08
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Study sites170→166
2020-06-03
Study Status, Contacts/Locations v29
Study sites168→170
2020-04-08
Study Status, Contacts/Locations v28
Study sites161→168
2020-03-03
Study Status, Contacts/Locations v27
Study sites153→161
2020-01-30
Study Status, Contacts/Locations v26
Study sites136→153
2020-01-06
Study Status, Contacts/Locations v25
Study sites134→136
2019-12-06
Study Status, Contacts/Locations v24
Study sites129→134
2019-12-05
Study Status, Contacts/Locations v23
Study sites126→129
2019-10-11
Study Status, Contacts/Locations v22
Study sites123→126
2019-09-16
Study Status, Contacts/Locations v21
Study sites120→123
2019-08-19
Study Status, Contacts/Locations v20
Study sites111→120
2019-07-12
Study Identification, Study Status, Sponsor/Collaborators v19
Collaborators1 to 2 entries
AstraZeneca
2019-07-10
Study Status, Contacts/Locations v18
Study sites100→111
2019-06-11
Study Status, Contacts/Locations v17
Study sites89→100
2019-05-08
Study Status, Contacts/Locations v16
Study sites69→89
2019-04-09
Study Status, Contacts/Locations v15
Study sites47→69
2019-04-01
Study Identification, Study Status v14
Re-verified, no change to tracked fields
2019-03-08
Study Status, Contacts/Locations v13
Study sites43→47
2019-02-26
Study Status, Contacts/Locations v12
Study sites30→43
2019-02-08
Study Status, IPDSharing v11
Re-verified, no change to tracked fields
2018-12-18
Study Status, Contacts/Locations, IPDSharing v10
Study sites15→30
2018-11-21
Study Status, Contacts/Locations v9
Study sites8→15
2018-10-12
Study Status, Outcome Measures, Eligibility v8
Eligibility criteria+772 characters
Inclusion Criteria: Is the age of majority in their country Has pathologically documented breast cancer that: is unresectable or metastatic Hashas confirmed HER2-positive expression as determined according [...] nical Oncology - College of American Pathologists guidelines, evaluated at a central laboratory Waswas previously treated with trastuzumab and taxane in the advan [...] tment or within 6 months after completing adjuvant therapy) Has an adequate tumor sample available for confirmation ofIs HER2 statuspositive as confirmed by Centralcentral Laboratorylaboratory (basedassessment onof most recent tumor [...] [...]
Secondary endpointsdetails revised at 5 of 5 entries
2018-09-21
Study Status, Contacts/Locations v7
Study sites4→8
2018-09-18
Study Identification, Study Status, Conditions v6
Study title+19 characters
[...] Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
2018-08-28
Study Status, Contacts/Locations v5
Study sites2→4
2018-08-20
Study Status v4
Re-verified, no change to tracked fields
2018-08-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-08-10→confirmed 2018-07-20
Study sites0→2
2018-05-31
Study Status, Eligibility v2
Eligibility criteria-8 characters
[...] effective form of contraception or avoid intercourse during and upon completion of the study, and for at least 4.5 months after thestudy completion Has adequate hematopoietic, renal and hepatic functions Exc [...]
2018-05-24
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, IPDSharing v1
InterventionsAdo-trastuzumab emtansine (Drug), Trastuzumab deruxtecan (Drug)→Ado-trastuzumab emtansine (T-DM1) (Drug), Trastuzumab deruxtecan (DS-8201a) (Drug)
Eligibility criteria-113 characters
Inclusion Criteria: MenIs orthe womenage ≥of 20 years oldmajority in Japantheir andcountry Has Korea, ≥ 18 years old in other countries Pathologicallypathologically documented breast cancer that: is unresectable or metastatic hasHas confirmed HER2-positive expression as determined according to American Soci [...] nical Oncology - College of American Pathologists guidelines, evaluated at a central laboratory wasWas previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 momonths after neoadjuvant or adjuvant treatment involving a regimen including tras [...] [...]
Study description-544 characters
Primary Objective: To compare the efficacy of DS-8201a compared to T-DM1 on PFS. Secondary Objectives: The secondary objectives are: To further compare the efficacy of DS-8201a compared to T DM1 on: Overall survival (OS); Objective response rate (ORR); Duration of response (DoR); Duration of Clinica [...]
Study title+23 characters
DS-8201a Versus Ado Trastuzumab EmtansineT-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
2018-05-07
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Trial Details
NCT Number NCT03529110
Lead Sponsor Daiichi Sankyo
Collaborators: Daiichi Sankyo Co., Ltd., AstraZeneca
Conditions Breast Cancer
Enrollment 524 participants
Start Date 2018-08-09
Primary Completion 2021-05-21 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-21