2024-10-23
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v25
Trial statusRecruiting→Active, Not Recruiting
Study sites158→156
2024-05-20
minor
Study Status, Contacts/Locations v24
Primary completion date2024-04-15→2025-10-01
Completion date2024-11-15→2026-02-01
Study sites157→158
Show 22 earlier versions
2024-01-08
minor
Study Status, Contacts/Locations v22
Study sitesdetails revised at 2 of 157 sites
2023-11-29
minor
Study Status, Contacts/Locations v21
Study sitesdetails revised at 8 of 157 sites
2023-09-05
minor
Study Status v20
Re-verified, no change to tracked fields
2023-08-14
minor
Study Status, Contacts/Locations v19
Study sitesdetails revised at 2 of 157 sites
2023-07-25
minor
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 157 sites
2023-07-05
minor
Study Status, Contacts/Locations v17
Study sites157 entries, revised
Hospital ClnicoClinico Universitario de Santiago de Compostela
2023-06-13
minor
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 157 sites
2023-05-22
minor
Study Status, Contacts/Locations v15
Study sitesdetails revised at 3 of 157 sites
2023-05-03
minor
Study Status, Contacts/Locations v14
Study sitesdetails revised at 2 of 157 sites
2023-04-12
minor
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 157 sites
2023-03-20
minor
Study Status, Contacts/Locations v12
Study sitesdetails revised at 4 of 157 sites
2023-02-20
minor
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v11
Eligibility criteria+248 characters
[...] herapy regardless of the progression status of the subject.
CentrallyLocally or centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of H [...] status of 0 or 1 at Screening.
Adequate bone marrow, renal, hepatic function, and hepaticblood clotting function within 14 days of randomization.
Exclusion Criteri [...] or partial bowel obstruction) in the opinion of Investigator
Has history of receiving live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention
Secondary endpointsdetails revised at 2 of 8 entries
Study description-53 characters
[...] gy (ASCO) College of American Pathologists (CAP) guidelines and confirmed by central assessment of tumor tissue) who have progressed on or after a trastuzumab-containing reg [...]
2023-01-17
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 3 of 165 sites
2023-01-04
minor
Study Status, Contacts/Locations v9
2022-10-13
minor
Study Status, Contacts/Locations v8
2022-09-16
minor
Study Status, Contacts/Locations v7
2022-08-16
minor
Study Status, Contacts/Locations v6
2022-04-18
minor
Study Status, Contacts/Locations v5
2022-01-18
minor
Study Status, Eligibility, Contacts/Locations v4
Eligibility criteria-122 characters
[...] roved trastuzumab biosimilar-containing regimen.
Note: Prior neoadjuvant or adjuvant therapy with a trastuzumab-containing regimen can [...] the subject progressed on or within 6 months of completing neoadjuvant or adjuvant therapy.
Prior neoadjuvant or adjuvant therapy that does not include trastuzumab will not be counted as a line of therapy regardless of the progression status of the subject.
Centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evid [...] Cooperative Oncology Group performance status of 0 or 1 at both Screening and within 3 days prior to randomization.
Adequate bone marrow, renal, [...] [...]
2021-09-09
minor
Study Status, Contacts/Locations v3
2021-07-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-06→confirmed 2021-05-21
Study sites0→9
2021-03-30
minor
Study Status v1
Start date2021-03-05→2021-06