2023-05-25
minor
Study Status, Outcome Measures, Participant Flow, Outcome Measures (Results), Adverse Events v30
Completion date2023-03→2024-03
Results first postednot stated→2023-06-15
Secondary endpoints9 to 10 entries
Number of Overall Survival Events (Deaths)
Overall Survival (OS) in Participants With HER2-low Breast Cancer (All Patients)
2023-02-15
minor
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v29
Secondary endpointsdetails revised at 5 of 9 entries
Show 28 earlier versions
2023-01-11
minor
Study Status, Outcome Measures, Eligibility, IPDSharing, References, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v28
Eligibility criteria+49 characters
[...] ted with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting
Was never previously HER2-positive (ICH 3 [...] 2 status
assessment of post-treatment status
Has at least 1 protocol-defined measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
Has protocol-defined adequate cardiac, bone marrow, renal, [...]
Secondary endpoints4 to 9 entries
PFS based on Investigator Assessment
OverallProgression-free Survival (OSPFS)
Objective Response Rate (ORR)
Duration of Response (DoR), Based on Blinded Independent Central Review (BICR) andin Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status
Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Overall Survival (OS) in Participants With HER2-low Breast Cancer (All Patients)
Progression-free [...] Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
P [...]
Primary endpoints1 entry, revised
Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Publicationsdetails revised at 1 of 9 entries
2022-12-14
minor
Study Status v27
Primary completion dateestimated 2023-01-01→confirmed 2022-01-11
Completion date2023-01-01→2023-03
2022-01-25
minor
Study Status v26
Re-verified, no change to tracked fields
2021-01-07
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v25
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 540→confirmed 557
Study sitesdetails revised at 208 of 208 sites
2020-10-19
minor
Study Status, Contacts/Locations v24
Study sitesdetails revised at 1 of 208 sites
2020-10-02
minor
Study Status, Contacts/Locations v23
2020-08-21
minor
Study Status, Contacts/Locations v22
2020-07-22
minor
Study Status, Contacts/Locations v21
2020-06-19
minor
Study Status, Contacts/Locations v20
2020-05-21
minor
Study Status, Contacts/Locations v19
2020-04-15
minor
Study Status, Contacts/Locations v18
2020-03-04
minor
Study Status, Contacts/Locations v17
2020-02-03
minor
Study Status, Contacts/Locations v16
2019-12-02
minor
Study Status, Contacts/Locations v15
2019-11-06
minor
Study Status, Contacts/Locations v14
2019-10-08
minor
Study Status, Contacts/Locations v13
2019-09-06
minor
Study Status, Contacts/Locations v12
2019-08-05
minor
Study Status, Contacts/Locations v11
2019-07-19
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v10
Primary completion date2022-01-01→2023-01-01
Completion date2022-01-01→2023-01-01
Study sites19→52
Eligibility criteria+265 characters
[...] or lines of chemotherapy/adjuvant in the metastatic setting
Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
Has documented radiologic progression (during or after most recent treatment)
Has adequate archival tumor samples available or is wiling to provide fresh biops [...] sessment of HER2 status
assessment of post-treatment status
Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Has at least 1 protocol-defined measurable lesion
Has protoc [...] c, bo [...]
Secondary endpoints4 entries, revised
Duration of Response (DoR), basedBased on Blinded Independent Central Review (BICR) and Investigator assessmentAssessment
Study description-527 characters
This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of DS8201atrastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer subjectsparticipants.
The study is expected to enroll ~360 DS-8201a subjects and ~180 physician's choice subjects:
60 hormone receptor (HR)-negative
240 HR-positive who have had prior therapy with a cyclin-dependent kinase (CDK) 4/6 inhibitor
240 HR-positive who are naive to treatment with CDK 4/6
There will be approxima [...] The Sponsor proposes to define a new HER2-low po [...]
Collaborators+36 characters
Daiichi Sankyo Co., Ltd.
AstraZeneca
Study title+25 characters
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer Tha [...]
2019-05-07
minor
Study Status, Contacts/Locations v9
2019-04-02
minor
Study Status, Contacts/Locations v8
2019-04-01
minor
Study Identification, Study Status v7
Re-verified, no change to tracked fields
2019-03-06
minor
Study Status, Contacts/Locations v6
2019-02-15
minor
Study Status, Contacts/Locations v5
Primary completion date2022-01→2022-01-01
Completion date2022-01→2022-01-01
Study sites3→8
2019-02-08
minor
Study Status, IPDSharing v4
Re-verified, no change to tracked fields
2019-01-07
minor
Study Status, Contacts/Locations v3
Start dateestimated 2018-12→confirmed 2018-12-27
Study sites2→3
2018-12-19
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, IPDSharing v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→2
2018-12-13
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria-2,337 characters
[...] documented breast cancer that:
Is unresectable or metastatic.
Has a history of low-HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
Is assessed by a central laboratory as low HER2 expression, defined as IHC 2+/ISH- or IHC 1+
Is HR-positive or HR-negative.
After ~60 HR-negative subjects are enrolled, further enrollment will be limited to only subjects who are HR-positive (either estrogen receptor positive or progesterone receptor positive per ASCO-CAP guidelines).
Is documented refractory to endocrine therapy, defined as havingHas progressed on at least 1 endocrine therapy, [...]
Secondary endpoints4 entries, revised
Confirmed Objective Response Rate (ORR)
Study description-212 characters
[...] safety and efficacy of DS8201a versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer s [...] ~360 DS-8201a subjects and ~180 physician's choice subjects.:
After ~60 hormone receptor (HR)-negative subjects have been enrolled, further enrollment will be limited to only subjects who have HR-positive disease.
After ~240 HR-positive subjects who have not had prior therapy with a cyclin-dependent kinase (CDK) 4/6 inhibitor
240 haveHR-positive beenwho enrolled,are further enrollment will be limitednaive to only subjects who have had prior therapytreatment with aCDK C [...] [...]
Study title-42 characters
DS-8201a ComparedVersus to Treatment of PhysicianInvestigator's Choice for Participants With a Certain Kind ofHER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]