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T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

StatusActive, Not Recruiting
PhasePhase 3
Started2021-03-02
View on ClinicalTrials.gov ↗

Amendment history

2026-06-11
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v22
Eligibility criteria+1,193 characters
Inclusion Criteria: • HER2-positive status will be based on pretreatment biopsy ma [...] hologists (CAP) guidelines. Central testing is not required * Known hormone receptor (HR) status as defined by ASCO/CAP gu [...] determined by both known negative ER and known negative PR • Patients with clinical stage T1-4, N0-3 disease at presentat [...] sive disease postoperatively as defined above are eligible. Patients with clinical stage TX disease at presentation are also eligible if their pathologic staging meets eligibility criteria. (Note: Patients with T1a/bN0 tumors are not eligible at init [...] s are not eligible) Pati [...]
Secondary endpoints6 to 7 entries
Disease-free survival
Study description+50 characters
[...] -DM1 alone (T-DM1 plus placebo) improves the following: Ia. Breast cancer freeOverall survival (BCFSOS). Ib. DistantBreast recurrencecancer-free survival (DRFSBCFS). Ic. Disease recurrence-free survival (DRFS) Id. Disease-free survival (DFS) Ie. Brain metastases-free survival (BMFS). Id. Overall survival (OS). II. To evaluate whether treatment with tucatinib plus T-DM1 [...] are followed up at 30 days, then every 6 months for 10 years after registration.
Study sitesdetails revised at 3 of 1176 sites
2025-10-28
Recruiting→Active, Not Recruiting Study Identification, Study Status, Oversight, Conditions, Study Design, Contacts/Locations v21
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 1031→confirmed 1056
Study sitesdetails revised at 1176 of 1176 sites
Study titlerevised
T-DM1 and Tucatinib Compared withWith T-DM1 Alone in Preventing Relapses in People withWith High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
2025-01-09
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v20
Primary completion date2028-01→2028-01-31
Completion date2035-05→2035-05-31
Start date2021-01-06→2021-03-02
Study sitesdetails revised at 805 of 1176 sites
Study titlerevised
T-DM1 and Tucatinib Compared Withwith T-DM1 Alone in Preventing Relapses in People Withwith High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
2024-08-01
Study Status, Contacts/Locations v19
Study sites1172→1176
2024-05-22
Study Status, Contacts/Locations v18
Study sites1154→1172
Show 17 earlier versions
2024-04-08
Study Status, Contacts/Locations v17
Study sites1145→1154
2024-02-19
Study Status, Contacts/Locations v16
Study sites1111→1145
2023-12-20
Study Status, Contacts/Locations v15
Study sites1105→1111
2023-08-30
Study Status, Contacts/Locations v14
Study sites1060→1105
2023-03-09
Study Status, Contacts/Locations v13
Study sites898→1060
2022-02-16
Study Status, Contacts/Locations v12
Study sites880→898
2022-01-11
Study Status, Contacts/Locations v11
Study sites871→880
2021-12-13
Study Status, Contacts/Locations v10
Study sites865→871
2021-11-11
Study Status, Contacts/Locations v9
Study sites864→865
2021-11-01
Study Status, Eligibility, Contacts/Locations v8
Study sites852→864
Eligibility criteria+1,949 characters
[...] rmone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by eith [...] determined by both known negative ER and known negative PR ⇅ moved Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible) Patients with residual HR-negative, HER2 positive (+) diseas [...] ve disease in the breast is not mandatory for these patients. Patients wi [...] [...]
2021-10-11
Study Status, Eligibility, Contacts/Locations v7
Study sites814→852
Eligibility criteria-1 characters
[...] l or paclitaxel is acceptable Patients may have received =< 21 cyclescycle of T-DM1 in the adjuvant setting. Note: These patients will [...]
2021-08-16
Study Status, Contacts/Locations v6
Study sites760→814
2021-07-19
Study Status, Contacts/Locations v5
Study sites737→760
2021-06-09
Study Status, Contacts/Locations v4
Study sites567→737
2021-04-16
Study Status, Contacts/Locations v3
Study sites454→567
2021-03-05
Study Status, Contacts/Locations v2
Study sites199→454
2021-02-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-01→confirmed 2021-01-06
Study sites0→199
2020-06-30
Original filing
This phase III trial compares the effect of usual treatment with trastuzumab emtansine (T-DM1) alone vs. T-DM1 in combination with tucatinib. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib is in a class of medications called kinase inhibitors. It blocks HER2, which may help keep cancer cells from growing and may kill them. Giving T-DM1 in combination with tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
Trial Details
NCT Number NCT04457596
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), Seagen Inc.
Conditions Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Multifocal Breast Carcinoma, Synchronous Bilateral Breast Carcinoma, Anatomic Stage I Breast Cancer AJCC v8
Enrollment 1,056 participants
Start Date 2021-03-02
Primary Completion 2028-01-31 (estimated)
Study Completion 2035-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-15