drugset / Trial / NCT01964391
A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.
Timeline
- Start
- 2014-02-21
- Primary completion
- 2016-12-22
- Completion
- 2018-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 600 mg | Subcutaneous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Paclitaxel | Small molecule | — | — |