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ATEMPT 2.0: Adjuvant T-DM1 vs TH

StatusRecruiting
PhasePhase 2
Started2021-06-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Nov 1, 2026 → Nov 1, 2028
See other at-risk trials from Dana-Farber Cancer Institute

Amendment history

2026-08-17
Study Status, Contacts/Locations v40
Primary completion pushed: 2026-11-01 → 2028-11-01
Completion pushed: 2028-05-01 → 2029-05-01
2026-07-20
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 53 sites
2026-04-21
Study Status, Contacts/Locations v38
Study sites52→53
2026-02-20
Study Status, Contacts/Locations v37
Study sites51→52
2025-11-12
Study Status, Oversight, Contacts/Locations v36
Study sites51 entries, revised
SarahGreco-Hainsworth CannonCenters for Research Institute/Tennessee Oncology
Show 35 earlier versions
2025-10-07
Study Status, Contacts/Locations v35
Study sites51 entries, revised
Sarah Cannon Research Institute/Tennessee Oncology - Nashville
2025-07-13
Study Status, Contacts/Locations v34
Study sites50→51
2025-06-03
Study Identification, Study Status, Contacts/Locations v33
Primary completion date2025-05-01→2026-11-01
Study sites49→50
Study titlerevised
ATEMPT 2.0: Adjuvant T-DM1 Vsvs TH
2024-11-13
Study Status, Contacts/Locations v32
Study sitesdetails revised at 4 of 49 sites
2024-09-30
Study Identification, Study Status, Oversight, Contacts/Locations v31
Study sitesdetails revised at 48 of 49 sites
Study titlerevised
ATEMPT 2.0: Adjuvant T-DM1 vsVs TH
2024-06-10
Study Status, Contacts/Locations v30
Study sites48→49
2024-06-04
Study Status, Contacts/Locations v29
Study sites47→48
2024-04-24
Study Status, Contacts/Locations v28
Study sites46→47
2024-02-03
Study Status, Eligibility v27
Eligibility criteria+28 characters
[...] heir primary HER2-positive tumor are eligible. HER2-positive: defined as 3+ by immunohistochemistry.ASCO FISHCAP results2018 willguidelines, notconfirmed beby consideredcentral for eligibilitytesting. NOTE: HER-2 status must be confirmed to be positive by cen [...] treated with wide excision alone, without radiation therapy, or treated with a mastectomy for this current breast cancer. Patients with a history of contralateral DCIS are not elig [...] nts who have undergone partial breast radiation (duration ≤ 714 days) prior to registration are eligible. Partial breast ra [...]
2024-01-17
Study Status, Contacts/Locations v26
Study sites45→46
2024-01-10
Study Status, Contacts/Locations v25
Study sitesdetails revised at 17 of 45 sites
2023-12-19
Study Status, Contacts/Locations v24
Study sites31→45
2023-03-10
Study Status, Contacts/Locations v23
Study sites29→31
2023-03-07
Study Status, Contacts/Locations v22
Study sitescontacts updated at 1 of 29 sites
2023-01-27
Study Status, Contacts/Locations v21
Study sitesdetails revised at 3 of 29 sites
2023-01-19
Study Status, Contacts/Locations v20
Study sites29 entries, revised
Miami Cancer Institute - Plantation (MCIP)
2023-01-12
Study Status, Contacts/Locations v19
Study sites27→29
2022-12-13
Study Status, Sponsor/Collaborators, Contacts/Locations v18
Study sites27 entries, revised
NHMD OncologyAnderson -Cancer HematologyCenter
2022-10-19
Study Status, Contacts/Locations v17
Study sites26→27
2022-09-27
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 26 sites
2022-09-21
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 26 sites
2022-09-20
Study Status, Contacts/Locations v14
Study sites23→26
2022-09-16
Study Status, Contacts/Locations v13
Study sites20→23
2022-08-25
Study Status, Contacts/Locations v12
Study sites17→20
2022-06-20
Study Status, Contacts/Locations v11
Study sites16→17
2022-04-27
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 16 sites
2022-04-19
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 16 sites
2022-03-01
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 16 sites
2022-02-18
Study Status, Contacts/Locations v7
Study sites15→16
2022-01-10
Study Status, Contacts/Locations v6
Study sites11→15
2021-12-22
Study Status, Contacts/Locations v5
Study sites10→11
2021-10-08
Study Status, Contacts/Locations v4
Study sites4→10
2021-07-12
Study Status v3
Start dateestimated 2021-06→confirmed 2021-06-16
2021-06-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2021-11→2021-06
Study sitesdetails revised at 4 of 4 sites
2021-05-21
Study Status, Contacts/Locations v1
Study sites4 entries, revised
BrighamDana-Farber andat Women's HospitalMilford
2021-05-18
Original filing
This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: * Trastuzumab-emtansine (T-DM1, Kadcyla) * Trastuzumab SC (Herceptin Hylecta) * Paclitaxel
Trial Details
NCT Number NCT04893109
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Genentech, Inc.
Conditions Breast Cancer, HER2-positive Breast Cancer
Enrollment 500 participants
Start Date 2021-06-16
Primary Completion 2028-11-01 (estimated)
Study Completion 2029-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-19