Drugs / Trastuzumab
Trastuzumab
DrugTrastuzumab is marketed as Herceptin and is a HER2/neu receptor antagonist used in HER2-overexpressing breast cancer and metastatic gastric/gastroesophageal junction adenocarcinoma. It is administered intravenously and requires companion diagnostic HER2 testing. U.S. initial approval was in 1998.
- Trials
- 978
- Recruiting
- 111
- Completed
- 485
- With results
- 308
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Approved for marketing | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 2 | 1 | 2 | — | 1 | — | 6 |
| Phase 1 | 5 | — | 9 | 82 | 12 | 2 | 2 | 3 | — | 115 |
| Phase 1/2 | 11 | 1 | 9 | 34 | 23 | 6 | — | 10 | — | 94 |
| Phase 2 | 54 | 22 | 40 | 231 | 57 | 14 | 1 | 66 | — | 485 |
| Phase 2/3 | 5 | 2 | 4 | 3 | 2 | — | — | 2 | — | 18 |
| Phase 3 | 27 | 7 | 19 | 97 | 12 | 3 | — | 15 | — | 180 |
| Phase 4 | 6 | 1 | 1 | 5 | 2 | — | — | 1 | — | 16 |
| Not applicable | 2 | 1 | 2 | 8 | 1 | 1 | — | 5 | — | 20 |
| Unknown | 1 | 1 | 2 | 23 | 3 | — | 1 | 11 | 2 | 44 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Breast Neoplasms | 4 | 76 | 62 | 311 | 5 | 122 | 12 | 14 | 32 | 638 |
| Stomach Neoplasms | 1 | 12 | 9 | 34 | 5 | 9 | 1 | 1 | 4 | 76 |
| Neoplasm Metastasis | — | 13 | 10 | 24 | — | 6 | 1 | 2 | 3 | 59 |
| Neoplasms | — | 8 | 4 | 16 | 2 | 4 | 1 | — | 4 | 39 |
| Breast Neoplasms, Male | — | 8 | 4 | 16 | — | 1 | — | 1 | — | 30 |
| Colorectal Neoplasms | — | 5 | 4 | 16 | 1 | 1 | — | 1 | — | 28 |
| Brain Neoplasms | 1 | 5 | 6 | 8 | — | 1 | 1 | 1 | 2 | 25 |
| Carcinoma, Non-Small-Cell Lung | — | 7 | 4 | 8 | — | — | — | 2 | — | 21 |
| Esophageal Neoplasms | — | 5 | 3 | 9 | — | 3 | — | — | — | 20 |
| Inflammatory Breast Neoplasms | — | 3 | 3 | 10 | — | 4 | — | — | — | 20 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Hoffmann-La Roche | 89 | 37 |
| 2 | National Cancer Institute (NCI) | 44 | 12 |
| 3 | Novartis Pharmaceuticals | 24 | 10 |
| 4 | Fudan University | 23 | 7 |
| 5 | Memorial Sloan Kettering Cancer Center | 19 | 0 |
| 6 | Dana-Farber Cancer Institute | 18 | 1 |
| 7 | Genentech, Inc. | 14 | 1 |
| 8 | M.D. Anderson Cancer Center | 11 | 1 |
| 9 | SCRI Development Innovations, LLC | 10 | 0 |
| 10 | City of Hope Medical Center | 9 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Trastuzumab | 978 |
| 2 | pertuzumab | 253 |
| 3 | Docetaxel | 213 |
| 4 | Paclitaxel | 207 |
| 5 | Cyclophosphamide | 126 |
| 6 | Capecitabine | 121 |
| 7 | Carboplatin | 119 |
| 8 | Doxorubicin | 69 |
| 9 | Lapatinib | 65 |
| 10 | Epirubicin | 59 |
Evidence
- Results reported
- 63.5%308 of 485 completed
- Published
- 17.5%85 of 485 completed
- Primary endpoint met
- 49.5%45 of 91 analyses
- Median months to report
- 18
Documents disclosed
Trial profile
- Median enrollment
- 70
- Median duration
- 58months
- Countries
- 91
- Study sites
- 16268
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 15
- Phase 1
- 41
- Phase 1/2
- 34
- Phase 2
- 58
- Phase 2/3
- 163
- Phase 3
- 482
- Phase 4
- 97
- Not applicable
- 44
- Unknown
- 129
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Boston | United States | 118 |
| 2 | New York | United States | 114 |
| 3 | Barcelona | Spain | 113 |
| 4 | Madrid | Spain | 110 |
| 5 | Houston | United States | 105 |
| 6 | Nashville | United States | 96 |
| 7 | Shanghai | China | 89 |
| 8 | Seoul | South Korea | 86 |
| 9 | Milan | Italy | 84 |
| 10 | Valencia | Spain | 82 |
Terminations
- Terminated
- 113
- Withdrawn
- 28
- Suspended
- 4
- Stopped for recruitment
- 4.5%44 of 978 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT04120246 Suspended | Suspended | Study placed on hold. | 2030-02-01 |
| NCT05062889 Suspended | Suspended | due to earlier termination of the agreement between the Sponsor and Central Laboratory for screening test. Enrollment will reopen as soon as a new laboratory is identified. | 2029-12-31 |
| NCT04419181 Withdrawn | Withdrawn | Change in the landscape of current treatment of early stage breast cancer. Larger clinical trials answering similar questions are expected to result in the next few years. | 2027-06-01 |
| NCT05378464 Suspended | Suspended | Wait for the DLT period with our current patient and will not be enrolling any more. | 2026-12-31 |
| NCT05238831 Withdrawn | Withdrawn | Withdrawn due to a change in therapeutic interventions. | 2026-05-31 |
| NCT03738553 Terminated | Terminated | Study closed to accrual after meeting grant enrollment goal, prior to reaching protocol accrual goal, due to end of funding. | 2026-03-01 |
| NCT07040059 Terminated | Terminated | Patient recruitment problems. | 2025-12-29 |
| NCT06038539 Terminated | Terminated | US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study. | 2025-12-23 |
| NCT05553522 Terminated | Terminated | Slow enrollment | 2025-12-17 |
| NCT03367676 Terminated | Terminated | Due to slower than anticipated enrollment, the study was terminated early after 78 patients were recruited. | 2025-10-01 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: