drugset / Trial / NCT01835236

Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

NCT01835236

Phase 2 Completed 208 enrolled Swiss Cancer Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.

Timeline

Start
2013-03-03
Primary completion
2018-01-11
Completion
2020-05-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Paclitaxel Small molecule 90 mg/m2 Intravenous
Comparator Pertuzumab Monoclonal antibody 420 mg Intravenous
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Comparator Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous
Comparator Vinorelbine Small molecule 30 mg/m2 Intravenous

Indications