MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
Summary
This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.
Timeline
- Start
- 2014-07
- Primary completion
- 2016-12
- Completion
- 2017-06
Outcome
Outcome not reported
Stopped: “Felt not to show benefit over control per DMC and confirmed via futility analysis”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | — | — |
| Subject | GANCOTAMAB | Other / unclassified | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Vinorelbine | Small molecule | — | — |
| Background | Trastuzumab | Monoclonal antibody | — | — |